Validant Company
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Validant Employees
Employee
Years
Job
Industry
Ryan Antisdale Ryan Antisdale's Validant Experience August 2013 - Present
Job Business Development Associate at Validant
Industry Marketing and Advertising
Experience
Validant August 2013 - Present
Validant April 2013 - August 2013
E. & J. Gallo Winery January 2013 - April 2013
Arizona Daily Wildcat February 2012 - December 2012
MKTG INC June 2012 - August 2012
Woodway Country Club May 2006 - August 2011
Colony Grill May 2009 - August 2010
Skills
Microsoft Office, PowerPoint skills, Excel, Social Networking, Social Media, Salesforce.com, Social Media Marketing, Sales, PowerPoint, Management, Event Management, Business Development, Microsoft Excel, Research, Project Planning, Advertising
Education
University of Arizona 2008 — 2012
Bachelor of Arts (BA), English Language and Literature, General, Communication, Senior
Validant August 2013 - Present
Validant April 2013 - August 2013
E. & J. Gallo Winery January 2013 - April 2013
Arizona Daily Wildcat February 2012 - December 2012
MKTG INC June 2012 - August 2012
Woodway Country Club May 2006 - August 2011
Colony Grill May 2009 - August 2010
Skills
Microsoft Office, PowerPoint skills, Excel, Social Networking, Social Media, Salesforce.com, Social Media Marketing, Sales, PowerPoint, Management, Event Management, Business Development, Microsoft Excel, Research, Project Planning, Advertising
Education
University of Arizona 2008 — 2012
Bachelor of Arts (BA), English Language and Literature, General, Communication, Senior
Ashley Ahwal Ashley Ahwal's Validant Experience October 2013 - April 2015
Job Finance Recruiting Manager at Truex Metier
Industry Financial Services
Experience
Truex Metier May 2015 - Present
Validant October 2013 - April 2015
Validant April 2013 - September 2013
Google October 2012 - March 2013
Skills
Social Networking, Recruiting, Customer Service, Strategy, Salesforce.com, Social Media, Public Speaking, Microsoft Excel, Project Planning, Multi-tasking Skills, Microsoft Word, Data Analysis, PowerPoint, Highly detail oriented, Quality Assurance, Google Analytics, Research, Youth Mentoring, Time Management, Educational Fundraising, Google Adwords, Cross-functional Team...
Education
Tracy High School
University of California, Santa Cruz
Political Science
Truex Metier May 2015 - Present
Validant October 2013 - April 2015
Validant April 2013 - September 2013
Google October 2012 - March 2013
Skills
Social Networking, Recruiting, Customer Service, Strategy, Salesforce.com, Social Media, Public Speaking, Microsoft Excel, Project Planning, Multi-tasking Skills, Microsoft Word, Data Analysis, PowerPoint, Highly detail oriented, Quality Assurance, Google Analytics, Research, Youth Mentoring, Time Management, Educational Fundraising, Google Adwords, Cross-functional Team...
Education
Tracy High School
University of California, Santa Cruz
Political Science
William L. Drake Jr, MS, PMP William L. Drake Jr, MS, PMP's Validant Experience 2015 - Present
Job Product Development Program Manager
Industry Medical Devices
Experience
Validant 2015 - Present
Covidien 2008 - 2014
Baxa Corporation 2006 - 2008
Skills
Product Development, Six Sigma, Cross-functional Team..., R&D, Program Management, Medical Devices, FDA, Testing, Design Control, ISO 13485, Leadership, Quality System, Product Design, Management, Design of Experiments, Product Launch, Engineering, Engineering Management, Manufacturing
Education
University of Colorado Denver 2005 — 2007
Master of Science (MS), Dual MS: Management, Finance, 3.95 cummulative GPA
Validant 2015 - Present
Covidien 2008 - 2014
Baxa Corporation 2006 - 2008
Skills
Product Development, Six Sigma, Cross-functional Team..., R&D, Program Management, Medical Devices, FDA, Testing, Design Control, ISO 13485, Leadership, Quality System, Product Design, Management, Design of Experiments, Product Launch, Engineering, Engineering Management, Manufacturing
Education
University of Colorado Denver 2005 — 2007
Master of Science (MS), Dual MS: Management, Finance, 3.95 cummulative GPA
Brittany Oliver Brittany Oliver's Validant Experience April 2012 - May 2014
Job Recruiter at Coinbase
Industry Staffing and Recruiting
Experience
Coinbase May 2014 - Present
Validant April 2012 - May 2014
Biocodex USA January 2011 - March 2012
Nordstrom 2007 - 2011
Skills
Adobe Creative Suite, Microsoft Office, Social Media, Salesforce.com, User Experience, Content Creation, Business Management, Facebook, Customer Service, Social Media Marketing, Pharmaceutical Industry, Pharmaceutical..., Biotechnology Industry, Recruiting, Medical Devices, Leadership, Management, Start-ups, Project Planning, Program Management, Strategy, Project Management, Sales Management, Social Networking, Marketing Strategy, Sales, Market Research, Interviews
Education
UCSB 2008 — 2010
Bachelor of Arts, Communication
Coinbase May 2014 - Present
Validant April 2012 - May 2014
Biocodex USA January 2011 - March 2012
Nordstrom 2007 - 2011
Skills
Adobe Creative Suite, Microsoft Office, Social Media, Salesforce.com, User Experience, Content Creation, Business Management, Facebook, Customer Service, Social Media Marketing, Pharmaceutical Industry, Pharmaceutical..., Biotechnology Industry, Recruiting, Medical Devices, Leadership, Management, Start-ups, Project Planning, Program Management, Strategy, Project Management, Sales Management, Social Networking, Marketing Strategy, Sales, Market Research, Interviews
Education
UCSB 2008 — 2010
Bachelor of Arts, Communication
April Baranowski April Baranowski's Validant Experience August 2014 - October 2014
Job Senior Associate, Quality Systems at Astellas Pharma
Industry Pharmaceuticals
Experience
Astellas Pharma October 2014 - Present
Validant August 2014 - October 2014
Maetrics, LLC December 2012 - June 2014
Baxter Healthcare July 2011 - December 2012
Mote Marine Laboratory January 2011 - April 2011
Skills
FDA, Medical Devices, Regulatory Affairs, Data Analysis, Change Control, Microsoft Office, Laboratory Equipment, Process Improvement, PowerPoint, Research, V&V, ISO 13485, Complaint Processing, MDR, FDA GMP, Adverse Event Reporting, 21 CFR Part 11, CAPA, Product Surveillance, Necropsy, Marine Mammals, Specimen Collection, Quality Consulting, Customer Support, Lean Process Improvement, Lean Projects, Quality Auditing, Technical Writing, Strategic Policy..., Reports, Healthcare Consulting, Quality Assurance, Quality Control, ISO 14971, Root Cause Analysis, Quality System
Education
St. Mary-of-the-Woods College 2007 — 2011
BS, Biology
Astellas Pharma October 2014 - Present
Validant August 2014 - October 2014
Maetrics, LLC December 2012 - June 2014
Baxter Healthcare July 2011 - December 2012
Mote Marine Laboratory January 2011 - April 2011
Skills
FDA, Medical Devices, Regulatory Affairs, Data Analysis, Change Control, Microsoft Office, Laboratory Equipment, Process Improvement, PowerPoint, Research, V&V, ISO 13485, Complaint Processing, MDR, FDA GMP, Adverse Event Reporting, 21 CFR Part 11, CAPA, Product Surveillance, Necropsy, Marine Mammals, Specimen Collection, Quality Consulting, Customer Support, Lean Process Improvement, Lean Projects, Quality Auditing, Technical Writing, Strategic Policy..., Reports, Healthcare Consulting, Quality Assurance, Quality Control, ISO 14971, Root Cause Analysis, Quality System
Education
St. Mary-of-the-Woods College 2007 — 2011
BS, Biology
Scott Hopkins Scott Hopkins's Validant Experience October 2011 - October 2012
Job Senior Quality Engineer at Volcano Corporation
Industry Medical Devices
Experience
Volcano Corporation November 2012 - Present
Validant October 2011 - October 2012
ArthroCare Corporation November 2005 - September 2011
ArthroCare Corporation August 2001 - November 2005
Intella Interventional Systems 2000 - 2001
SURx 1998 - 2000
LaserScope 1994 - 1997
Skills
Quality Systems, Quality Engineering, ISO 13485, Medical Devices, Design Control, FDA, CAPA, ISO, QSR, Product Development, SPC, Validation, Process Development, GMP, FMEA, Regulatory Affairs, Quality Management, Process Validation, Compliance, Process Engineering, V&V, Quality System
Education
Oregon Institute of Technology 1990 — 1994
BS, Laser Optical Engineering
Volcano Corporation November 2012 - Present
Validant October 2011 - October 2012
ArthroCare Corporation November 2005 - September 2011
ArthroCare Corporation August 2001 - November 2005
Intella Interventional Systems 2000 - 2001
SURx 1998 - 2000
LaserScope 1994 - 1997
Skills
Quality Systems, Quality Engineering, ISO 13485, Medical Devices, Design Control, FDA, CAPA, ISO, QSR, Product Development, SPC, Validation, Process Development, GMP, FMEA, Regulatory Affairs, Quality Management, Process Validation, Compliance, Process Engineering, V&V, Quality System
Education
Oregon Institute of Technology 1990 — 1994
BS, Laser Optical Engineering
Matthew Gross Matthew Gross's Validant Experience February 2015 - April 2015
Job Senior Research Associate II at Gilead Sciences
Industry Pharmaceuticals
Experience
Gilead Sciences June 2015 - Present
Neozene, Inc. April 2015 - May 2015
Validant February 2015 - April 2015
Irvine Pharmaceutical Services February 2014 - December 2014
Bayer HealthCare April 2011 - July 2013
KU Medical Center March 2011 - April 2011
PRA International July 2010 - December 2010
Aptuit July 2007 - August 2009
Aptuit February 2007 - July 2007
Aptuit / Quintiles March 2002 - February 2007
Skills
Sop, Pharmaceutical Industry, GLP, HPLC, LC-MS, FDA, CRO, Validation, GMP, Quality Control, Laboratory, Technology Transfer, Bioanalysis, R&D, Cleaning Validation, Analytical Chemistry, Protein Chemistry, LIMS, Chromatography, Biopharmaceuticals, 21 CFR Part 11
Education
University of Nebraska-Lincoln
B.S., Chemistry
Gilead Sciences June 2015 - Present
Neozene, Inc. April 2015 - May 2015
Validant February 2015 - April 2015
Irvine Pharmaceutical Services February 2014 - December 2014
Bayer HealthCare April 2011 - July 2013
KU Medical Center March 2011 - April 2011
PRA International July 2010 - December 2010
Aptuit July 2007 - August 2009
Aptuit February 2007 - July 2007
Aptuit / Quintiles March 2002 - February 2007
Skills
Sop, Pharmaceutical Industry, GLP, HPLC, LC-MS, FDA, CRO, Validation, GMP, Quality Control, Laboratory, Technology Transfer, Bioanalysis, R&D, Cleaning Validation, Analytical Chemistry, Protein Chemistry, LIMS, Chromatography, Biopharmaceuticals, 21 CFR Part 11
Education
University of Nebraska-Lincoln
B.S., Chemistry
Jonathon Moore Jonathon Moore's Validant Experience August 2013 - Present
Job Recruiter At Validant
Industry Staffing and Recruiting
Experience
Validant August 2013 - Present
ITT Technical Institute November 2011 - August 2013
ITT Technical Institute March 2011 - November 2011
Skills
Higher Education, Student Financial Aid, Admissions, Campus, Enrollment Management, Retaining Customers, Student Recruiting, Resume Writing, Higher Education..., Career Counseling, Financial Aid..., FDA, Training, Career Development, Management, Technical Recruiting, Leadership, Customer Service, Consulting, Cross-functional Team..., Medical Devices, Recruiting, Internet Recruiting, Biotechnology, Microsoft Office
Education
The Defiance College
Bachelor of Arts (B.A.), Business Administration and Management, General
Validant August 2013 - Present
ITT Technical Institute November 2011 - August 2013
ITT Technical Institute March 2011 - November 2011
Skills
Higher Education, Student Financial Aid, Admissions, Campus, Enrollment Management, Retaining Customers, Student Recruiting, Resume Writing, Higher Education..., Career Counseling, Financial Aid..., FDA, Training, Career Development, Management, Technical Recruiting, Leadership, Customer Service, Consulting, Cross-functional Team..., Medical Devices, Recruiting, Internet Recruiting, Biotechnology, Microsoft Office
Education
The Defiance College
Bachelor of Arts (B.A.), Business Administration and Management, General
Connie Hetzler Connie Hetzler's Validant Experience June 2013 - October 2013
Job Senior Director Validation North America at Alere, Inc.
Industry Medical Devices
Experience
Alere, Inc. November 2013 - Present
Validant June 2013 - October 2013
Baxter Healthcare October 2011 - May 2013
Baxter International Inc. October 2010 - September 2011
BD June 2008 - October 2010
BD May 2004 - May 2008
BD January 2002 - May 2004
BD January 1999 - January 2002
BD March 1998 - January 1999
Kimberly-Clark June 1993 - March 1998
Skills
Design Control, Quality Risk Management, Cross-functional Team..., Manage Client..., Organizational Change..., Global Resource..., Talent Management, Training Facilitation, Program Facilitation, Operational Efficiency, Risk Management, Drug Delivery, Regulatory Compliance, Product Development, Six Sigma, Change Management, Marketing Strategy, Program Management, Medical Devices, Process Improvement, CAPA, Strategy, Business Development, Leadership, R&D, Biotechnology, Management, Market Research, Analysis, Training, Integration, Testing, Project Planning, FDA, CRM, V&V, Validation, Regulatory Requirements, Pharmaceutics, Change Control, Project Management, ISO 13485, GMP, Biopharmaceuticals
Education
University of Wisconsin - Green Bay 1988 — 1992
Master of Science (M.S.), Environmental Science and Policy
Purdue University 1981 — 1986
Bachelor of Science Chemical Engineering
Alere, Inc. November 2013 - Present
Validant June 2013 - October 2013
Baxter Healthcare October 2011 - May 2013
Baxter International Inc. October 2010 - September 2011
BD June 2008 - October 2010
BD May 2004 - May 2008
BD January 2002 - May 2004
BD January 1999 - January 2002
BD March 1998 - January 1999
Kimberly-Clark June 1993 - March 1998
Skills
Design Control, Quality Risk Management, Cross-functional Team..., Manage Client..., Organizational Change..., Global Resource..., Talent Management, Training Facilitation, Program Facilitation, Operational Efficiency, Risk Management, Drug Delivery, Regulatory Compliance, Product Development, Six Sigma, Change Management, Marketing Strategy, Program Management, Medical Devices, Process Improvement, CAPA, Strategy, Business Development, Leadership, R&D, Biotechnology, Management, Market Research, Analysis, Training, Integration, Testing, Project Planning, FDA, CRM, V&V, Validation, Regulatory Requirements, Pharmaceutics, Change Control, Project Management, ISO 13485, GMP, Biopharmaceuticals
Education
University of Wisconsin - Green Bay 1988 — 1992
Master of Science (M.S.), Environmental Science and Policy
Purdue University 1981 — 1986
Bachelor of Science Chemical Engineering
Robert Bergstrand Robert Bergstrand's Validant Experience April 2015 - Present
Job Quality Manager/Pharmaceutical Professional
Industry Pharmaceuticals
Experience
Validant April 2015 - Present
Actavis plc April 2013 - January 2015
Actavis plc September 2008 - March 2013
Actavis plc January 2008 - September 2008
Actavis plc April 2006 - December 2007
Actavis plc February 2003 - March 2006
Actavis plc July 2000 - January 2003
Actavis plc January 1999 - June 2000
Actavis plc January 1995 - December 1998
Eastman Chemical Company October 1994 - December 1994
Skills
HPLC, GMP, Quality Assurance, V&V, Cross-functional Team..., Sop, Quality System, FDA, Quality Control, R&D, Management, 21 CFR Part 11
Education
Occidental College 1990 — 1994
Bachelor's Degree, Chemistry
Validant April 2015 - Present
Actavis plc April 2013 - January 2015
Actavis plc September 2008 - March 2013
Actavis plc January 2008 - September 2008
Actavis plc April 2006 - December 2007
Actavis plc February 2003 - March 2006
Actavis plc July 2000 - January 2003
Actavis plc January 1999 - June 2000
Actavis plc January 1995 - December 1998
Eastman Chemical Company October 1994 - December 1994
Skills
HPLC, GMP, Quality Assurance, V&V, Cross-functional Team..., Sop, Quality System, FDA, Quality Control, R&D, Management, 21 CFR Part 11
Education
Occidental College 1990 — 1994
Bachelor's Degree, Chemistry
Brenda Bruyere Brenda Bruyere's Validant Experience February 2012 - October 2013
Job Sr. Quality Consultant at Oxford International
Industry Medical Devices
Experience
Oxford International November 2013 - Present
Validant February 2012 - October 2013
Genzyme November 1995 - December 2011
Skills
Certified Auditor, Batch record review, Internal Audits, Supplier Audits, Supplier Qualification, Change Control, Document Control, Product Complaints, Product Recall, BPDRs & Field Alerts, Document Management, CQA, Recalls, Internal Audit, GMP, Computer System..., Reviews, Quality System, Sop, Validation, CAPA, GxP, Medical Devices, FDA, GAMP, V&V, 21 CFR Part 11, Pharmaceutical Industry, Biotechnology, Supplier Evaluation, SOP
Education
Northeastern University
Oxford International November 2013 - Present
Validant February 2012 - October 2013
Genzyme November 1995 - December 2011
Skills
Certified Auditor, Batch record review, Internal Audits, Supplier Audits, Supplier Qualification, Change Control, Document Control, Product Complaints, Product Recall, BPDRs & Field Alerts, Document Management, CQA, Recalls, Internal Audit, GMP, Computer System..., Reviews, Quality System, Sop, Validation, CAPA, GxP, Medical Devices, FDA, GAMP, V&V, 21 CFR Part 11, Pharmaceutical Industry, Biotechnology, Supplier Evaluation, SOP
Education
Northeastern University
Richard MacDonald Richard MacDonald's Validant Experience July 2014 - Present
Job Validation Engineer with Validant contracted to Meridian/Pfizer in St. Louis, Mo
Industry Pharmaceuticals
Experience
Validant July 2014 - Present
ProPharma Group March 2014 - June 2014
ProPharma Group October 2012 - January 2014
Novartis February 2012 - October 2012
ProPharma Group August 2011 - December 2011
ProPharma Group September 2010 - June 2011
ProPharma Group June 2010 - August 2010
Novartis Vaccines and Diagnostics July 2009 - February 2010
Pfizer 2006 - 2008
Pfizer August 1987 - December 2006
Skills
Validation, Process Validation, Technology Transfer, Manufacturing, Aseptic Processing, Biopharmaceuticals, V&V, Sop, Root Cause Analysis, Pharmaceutics, Change Control, GMP, CAPA, FDA, GAMP, GxP, Computer System..., 21 CFR Part 11, Quality System, Pharmaceutical Industry, Quality Auditing, Testing, Sterilization, Regulatory Requirements, LIMS, ISO 13485, Quality Control, GLP, Quality Assurance, Cleaning Validation, Calibration, Biotechnology, Regulatory Affairs, Medical Devices, Vaccines, Process Simulation, Quality Management, Lifesciences, R&D, Trackwise, Microbiology, ISO, Design of Experiments, Software Documentation, Six Sigma, Process Improvement, Continuous Improvement, Document Management, Process Engineering, TrackWise
Education
University of Phoenix
BSBM, Management
Validant July 2014 - Present
ProPharma Group March 2014 - June 2014
ProPharma Group October 2012 - January 2014
Novartis February 2012 - October 2012
ProPharma Group August 2011 - December 2011
ProPharma Group September 2010 - June 2011
ProPharma Group June 2010 - August 2010
Novartis Vaccines and Diagnostics July 2009 - February 2010
Pfizer 2006 - 2008
Pfizer August 1987 - December 2006
Skills
Validation, Process Validation, Technology Transfer, Manufacturing, Aseptic Processing, Biopharmaceuticals, V&V, Sop, Root Cause Analysis, Pharmaceutics, Change Control, GMP, CAPA, FDA, GAMP, GxP, Computer System..., 21 CFR Part 11, Quality System, Pharmaceutical Industry, Quality Auditing, Testing, Sterilization, Regulatory Requirements, LIMS, ISO 13485, Quality Control, GLP, Quality Assurance, Cleaning Validation, Calibration, Biotechnology, Regulatory Affairs, Medical Devices, Vaccines, Process Simulation, Quality Management, Lifesciences, R&D, Trackwise, Microbiology, ISO, Design of Experiments, Software Documentation, Six Sigma, Process Improvement, Continuous Improvement, Document Management, Process Engineering, TrackWise
Education
University of Phoenix
BSBM, Management
Michael Beatrice Michael Beatrice's Validant Experience May 2013 - Present
Job President Validant
Industry Management Consulting
Experience
Validant May 2013 - Present
Abbott Laboratories November 1999 - October 2012
Quintiles Transnational March 1996 - October 1999
United States Public Health Service 1994 - 1996
United States Food and Drug Administration (FDA) 1975 - 1996
National Institutes of Health 1974 - 1975
Skills
Teaching, Lecturing, Pharmaceutical Industry, Regulations, Program Management, Consulting, Product Development, FDA, Regulatory Affairs, Pharmacy Practice, GMP, Quality System, Quality Assurance, IND, Biotechnology, Regulatory Submissions, Medical Devices, CAPA, Drug Development, Sop, Regulatory Requirements, Validation, R&D, 21 CFR Part 11, Clinical Development, Biopharmaceuticals, V&V, Clinical Research, Computer System..., Technology Transfer, Change Control, GLP, Quality Auditing, GxP, Clinical Trials, Lifesciences, SOP, Life Sciences
Education
University of Maryland Baltimore 1988 — 2001
PhD, Pharmaceutics
University of Oklahoma 1972 — 1974
MS, Pharmacy
The University of New Mexico
BS, Pharmacy
Validant May 2013 - Present
Abbott Laboratories November 1999 - October 2012
Quintiles Transnational March 1996 - October 1999
United States Public Health Service 1994 - 1996
United States Food and Drug Administration (FDA) 1975 - 1996
National Institutes of Health 1974 - 1975
Skills
Teaching, Lecturing, Pharmaceutical Industry, Regulations, Program Management, Consulting, Product Development, FDA, Regulatory Affairs, Pharmacy Practice, GMP, Quality System, Quality Assurance, IND, Biotechnology, Regulatory Submissions, Medical Devices, CAPA, Drug Development, Sop, Regulatory Requirements, Validation, R&D, 21 CFR Part 11, Clinical Development, Biopharmaceuticals, V&V, Clinical Research, Computer System..., Technology Transfer, Change Control, GLP, Quality Auditing, GxP, Clinical Trials, Lifesciences, SOP, Life Sciences
Education
University of Maryland Baltimore 1988 — 2001
PhD, Pharmaceutics
University of Oklahoma 1972 — 1974
MS, Pharmacy
The University of New Mexico
BS, Pharmacy
Connie So Connie So's Validant Experience August 2013 - September 2014
Job International Student Programs at Ohlone College
Industry Higher Education
Experience
Ohlone College: International Programs & Services September 2014 - Present
Validant August 2013 - September 2014
UCSC International Education Office September 2012 - June 2013
Delta Sigma Pi: Professional Business Fraternity January 2012 - December 2012
Volunteer Center of Santa Cruz County July 2011 - January 2012
Delta Sigma Pi: Professional Business Fraternity June 2011 - December 2011
Skills
Leadership, Social Networking, Marketing, Social Media, Community Outreach, Research, Email Marketing, Newsletters, Market Research, Business Development, Event Planning, Recruiting, Data Entry, Interviews, Marketing Strategy, Strategy, Project Planning, Event Management, Fundraising, Time Management, Social Media Marketing, Public Speaking, Nonprofits
Education
University of California, Santa Cruz
Bachelor of Arts (B.A.), Business Management Economics
University of California, Santa Cruz
Bachelor of Arts (B.A.), Psychology
Ohlone College: International Programs & Services September 2014 - Present
Validant August 2013 - September 2014
UCSC International Education Office September 2012 - June 2013
Delta Sigma Pi: Professional Business Fraternity January 2012 - December 2012
Volunteer Center of Santa Cruz County July 2011 - January 2012
Delta Sigma Pi: Professional Business Fraternity June 2011 - December 2011
Skills
Leadership, Social Networking, Marketing, Social Media, Community Outreach, Research, Email Marketing, Newsletters, Market Research, Business Development, Event Planning, Recruiting, Data Entry, Interviews, Marketing Strategy, Strategy, Project Planning, Event Management, Fundraising, Time Management, Social Media Marketing, Public Speaking, Nonprofits
Education
University of California, Santa Cruz
Bachelor of Arts (B.A.), Business Management Economics
University of California, Santa Cruz
Bachelor of Arts (B.A.), Psychology
Eliezer Concepcion Eliezer Concepcion's Validant Experience June 2013 - April 2015
Job Talent Acquisition Manager Life Sciences Executive Search
Industry Human Resources
Experience
Life Sciences Executive Search Firm June 2015 - Present
Validant June 2013 - April 2015
Validant February 2012 - June 2013
Validant January 2012 - February 2012
Validant August 2011 - January 2012
Lash Group June 2010 - July 2011
Genentech June 2006 - December 2008
Macy's April 2004 - February 2007
Skyline College 2002 - 2007
Skills
FDA, Biotechnology, Medical Devices, Pharmaceutical Industry, Lifesciences, 21 CFR Part 11, Biopharmaceuticals, Quality System, Regulatory Affairs, Laboratory, LIMS, Pharmaceutics, Cross-functional Team..., Recruiting, Analytical Chemistry, Leadership, Clinical Trials, Technology Transfer, Process Improvement, Sop, Chemistry, Project Management, Quality Auditing, Quality Control, Microbiology, GCP, Software Documentation, ISO 13485, Microsoft Office, Tactical Planning, Technical Recruiting, R&D, Clinical Development, Regulatory Submissions, Protein Chemistry, Temporary Placement, Hardware Diagnostics, Quality Management, Cell Culture, PCR, Healthcare, Oncology, Biochemistry, Clinical Research, Molecular Biology, ELISA, Data Analysis, Technical Writing, Drug Development, UV/Vis
Education
University of California, San Diego 2007 — 2009
B.S., Human Biology
Skyline College
A.S., Biotechnology/Natural Science
Life Sciences Executive Search Firm June 2015 - Present
Validant June 2013 - April 2015
Validant February 2012 - June 2013
Validant January 2012 - February 2012
Validant August 2011 - January 2012
Lash Group June 2010 - July 2011
Genentech June 2006 - December 2008
Macy's April 2004 - February 2007
Skyline College 2002 - 2007
Skills
FDA, Biotechnology, Medical Devices, Pharmaceutical Industry, Lifesciences, 21 CFR Part 11, Biopharmaceuticals, Quality System, Regulatory Affairs, Laboratory, LIMS, Pharmaceutics, Cross-functional Team..., Recruiting, Analytical Chemistry, Leadership, Clinical Trials, Technology Transfer, Process Improvement, Sop, Chemistry, Project Management, Quality Auditing, Quality Control, Microbiology, GCP, Software Documentation, ISO 13485, Microsoft Office, Tactical Planning, Technical Recruiting, R&D, Clinical Development, Regulatory Submissions, Protein Chemistry, Temporary Placement, Hardware Diagnostics, Quality Management, Cell Culture, PCR, Healthcare, Oncology, Biochemistry, Clinical Research, Molecular Biology, ELISA, Data Analysis, Technical Writing, Drug Development, UV/Vis
Education
University of California, San Diego 2007 — 2009
B.S., Human Biology
Skyline College
A.S., Biotechnology/Natural Science
Colin Larsen's Validant Experience September 2012 - Present
Job Client Services Manager at Validant
Industry Medical Devices
Experience
Validant September 2012 - Present
Validant Consulting July 2008 - September 2012
Apex Systems, Inc. August 2006 - July 2008
Apex Systems, Inc. June 2005 - August 2006
Skills
Regulatory Affairs, Quality System, Applicant Tracking..., Medical Devices, Business Development, Contract Recruitment, Biotechnology, Recruiting, Consulting, Sourcing, Technical Recruiting, FDA, Quality Assurance, ISO 13485, Outsourcing, Pharmaceutical Industry, Validation, CAPA
Education
San Diego State University-California State University 2000 — 2005
Bachelor of Science (B.S.), Business Administration - Marketing
Validant September 2012 - Present
Validant Consulting July 2008 - September 2012
Apex Systems, Inc. August 2006 - July 2008
Apex Systems, Inc. June 2005 - August 2006
Skills
Regulatory Affairs, Quality System, Applicant Tracking..., Medical Devices, Business Development, Contract Recruitment, Biotechnology, Recruiting, Consulting, Sourcing, Technical Recruiting, FDA, Quality Assurance, ISO 13485, Outsourcing, Pharmaceutical Industry, Validation, CAPA
Education
San Diego State University-California State University 2000 — 2005
Bachelor of Science (B.S.), Business Administration - Marketing
Mara (Yanoshik) Mitchell's Validant Experience July 2013 - Present
Job Client Services Manager at Validant
Industry Pharmaceuticals
Experience
Validant July 2013 - Present
Validant April 2012 - July 2013
Panama Lens July 2009 - April 2012
Prime Realty August 2011 - March 2012
New York One News Station January 2007 - June 2007
Skills
Pharmaceutical Industry, Social Media Marketing, Social Media, Validation, Negotiation, Customer Service, Team Leadership, Data Analysis, Consulting, Cross-functional Team..., Pharmaceutics, Research, Marketing, Medical Devices, Biotechnology, New Business Development, Regulatory Affairs, Sales, Leadership, Microsoft Office, Market Research, Project Planning, Event Planning, Copywriting, Quality System, Strategic Planning, Microsoft Excel, Strategy, Budgets, Social Networking, PowerPoint, Public Relations, Sales Management, Account Management, Management, Team Building, Event Management, Advertising, Technical Recruiting, Process Improvement, Outlook, Marketing Strategy, Contract Negotiation, Public Speaking, Microsoft Word, Real Estate, Recruiting, Business Strategy, Training, Time Management
Education
Pace University, Dyson College of Arts and Sciences 2004 — 2008
Bachelor of Arts, Communication Studies, 3.6 GPA Cum Laude
University of Virginia 2007 — 2007
University of Pittsburgh 2005 — 2005
Quince Orchard High School 2000 — 2004
Validant July 2013 - Present
Validant April 2012 - July 2013
Panama Lens July 2009 - April 2012
Prime Realty August 2011 - March 2012
New York One News Station January 2007 - June 2007
Skills
Pharmaceutical Industry, Social Media Marketing, Social Media, Validation, Negotiation, Customer Service, Team Leadership, Data Analysis, Consulting, Cross-functional Team..., Pharmaceutics, Research, Marketing, Medical Devices, Biotechnology, New Business Development, Regulatory Affairs, Sales, Leadership, Microsoft Office, Market Research, Project Planning, Event Planning, Copywriting, Quality System, Strategic Planning, Microsoft Excel, Strategy, Budgets, Social Networking, PowerPoint, Public Relations, Sales Management, Account Management, Management, Team Building, Event Management, Advertising, Technical Recruiting, Process Improvement, Outlook, Marketing Strategy, Contract Negotiation, Public Speaking, Microsoft Word, Real Estate, Recruiting, Business Strategy, Training, Time Management
Education
Pace University, Dyson College of Arts and Sciences 2004 — 2008
Bachelor of Arts, Communication Studies, 3.6 GPA Cum Laude
University of Virginia 2007 — 2007
University of Pittsburgh 2005 — 2005
Quince Orchard High School 2000 — 2004
Anna Cross Anna Cross's Validant Experience 2013 - June 2014
Job Science Department Program Coordinator at UC Berkeley Extension
Industry Higher Education
Experience
UC Berkeley Extension August 2014 - Present
Validant 2013 - June 2014
Teach For America 2012 - 2013
UC Berkeley 2010 - 2012
UC Berkeley 2009 - 2011
Cytokinetics 2008 - 2009
Cytokinetics 2007 - 2008
Skills
Gel Electrophoresis, Immunohistochemistry, Histology, PCR, Cell Culture, Lifesciences, Biotechnology, Microsoft Office, Phone Screening, Science Education, Strategic Planning, Molecular Biology, Human Biology, Organic Chemistry, Experimental Design, Curriculum Design, Curriculum Development, Literacy, Laboratory, Bacterial Transformation, Bacterial Culture, NMR, Titration, Necropsy, Tissue Processing, Staining, Oracle Calendar, Microscopy, GLP, Microbiology, FDA, Life Sciences
Education
University of California, Berkeley
Bachelor of Arts, Integrative Biology, Human Biology & Health Sciences
UC Berkeley Extension August 2014 - Present
Validant 2013 - June 2014
Teach For America 2012 - 2013
UC Berkeley 2010 - 2012
UC Berkeley 2009 - 2011
Cytokinetics 2008 - 2009
Cytokinetics 2007 - 2008
Skills
Gel Electrophoresis, Immunohistochemistry, Histology, PCR, Cell Culture, Lifesciences, Biotechnology, Microsoft Office, Phone Screening, Science Education, Strategic Planning, Molecular Biology, Human Biology, Organic Chemistry, Experimental Design, Curriculum Design, Curriculum Development, Literacy, Laboratory, Bacterial Transformation, Bacterial Culture, NMR, Titration, Necropsy, Tissue Processing, Staining, Oracle Calendar, Microscopy, GLP, Microbiology, FDA, Life Sciences
Education
University of California, Berkeley
Bachelor of Arts, Integrative Biology, Human Biology & Health Sciences
Ingrid Warner, MBA Ingrid Warner, MBA's Validant Experience March 2013 - July 2013
Job Quality Systems, Biotechnology Professional
Industry Pharmaceuticals
Experience
Wellstat Management Company October 2014 - Present
Wellstat Management Company July 2013 - Present
Validant March 2013 - July 2013
Hill Dermaceuticals, Inc. April 2008 - July 2012
Hill Dermaceuticals, Inc. December 2001 - April 2008
Skills
SOP, Quality Assurance, Validation, Pharmaceutical Industry, GMP, Product Development, Healthcare, Regulatory Submissions, Microsoft Office, Program Management, Sop, Medical Devices, Root Cause Analysis, Coaching, Project Planning, Product Launch, Account Management, Strategic Planning, PowerPoint, Project Management
Education
University of Central Florida - College of Business Administration 2001 — 2003
Master of Business Administration (M.B.A.), Concentration in Health Services Management
University of Central Florida 1997 — 2000
Bachelor of Science (B.S.), Health Services Administration
Wellstat Management Company October 2014 - Present
Wellstat Management Company July 2013 - Present
Validant March 2013 - July 2013
Hill Dermaceuticals, Inc. April 2008 - July 2012
Hill Dermaceuticals, Inc. December 2001 - April 2008
Skills
SOP, Quality Assurance, Validation, Pharmaceutical Industry, GMP, Product Development, Healthcare, Regulatory Submissions, Microsoft Office, Program Management, Sop, Medical Devices, Root Cause Analysis, Coaching, Project Planning, Product Launch, Account Management, Strategic Planning, PowerPoint, Project Management
Education
University of Central Florida - College of Business Administration 2001 — 2003
Master of Business Administration (M.B.A.), Concentration in Health Services Management
University of Central Florida 1997 — 2000
Bachelor of Science (B.S.), Health Services Administration
David Betts David Betts's Validant Experience November 2012 - March 2013
Job Laboratory Operations Manager, Sterility Assurance Testing Services at NAMSA
Industry Biotechnology
Experience
NAMSA February 2015 - Present
Ajinomoto Althea, Inc March 2013 - February 2015
Validant November 2012 - March 2013
Dendreon April 2011 - November 2012
Cognate BioServices August 2007 - April 2011
KV Pharmaceutical October 2005 - August 2007
Cell Genesys 2002 - 2005
InSite Vision 1996 - 2002
Allergan 1993 - 1996
Bolin Laboratories 1992 - 1993
Skills
GMP, Technology Transfer, Auditing, Microbiology, Bioanalysis, Biotechnology, Validation, Biopharmaceuticals, LIMS, Sop, GLP, FDA, Cell Culture, V&V, Quality Assurance, Medical Devices, Sterilization, ELISA, 21 CFR Part 11, Pharmaceutical Industry, Assay Development, Laboratory, Computer System..., CAPA, PCR, Quality Control, FDA GMP, SOP, Life Sciences, Change Control, Quality System, Aseptic Processing, Pharmaceutics
Education
University of Arizona 1988 — 1992
BS, Microbiology
NAMSA February 2015 - Present
Ajinomoto Althea, Inc March 2013 - February 2015
Validant November 2012 - March 2013
Dendreon April 2011 - November 2012
Cognate BioServices August 2007 - April 2011
KV Pharmaceutical October 2005 - August 2007
Cell Genesys 2002 - 2005
InSite Vision 1996 - 2002
Allergan 1993 - 1996
Bolin Laboratories 1992 - 1993
Skills
GMP, Technology Transfer, Auditing, Microbiology, Bioanalysis, Biotechnology, Validation, Biopharmaceuticals, LIMS, Sop, GLP, FDA, Cell Culture, V&V, Quality Assurance, Medical Devices, Sterilization, ELISA, 21 CFR Part 11, Pharmaceutical Industry, Assay Development, Laboratory, Computer System..., CAPA, PCR, Quality Control, FDA GMP, SOP, Life Sciences, Change Control, Quality System, Aseptic Processing, Pharmaceutics
Education
University of Arizona 1988 — 1992
BS, Microbiology
Sean Mulhern's Validant Experience April 2012 - September 2013
Job MBA Candidate at Seton Hall University
Industry Marketing and Advertising
Experience
Seton Hall University August 2014 - Present
Seton Hall University- Stillman School of Business August 2014 - Present
Validant April 2012 - September 2013
University of Kansas Athletics August 2008 - May 2011
Skills
Recruiting, Training, Management, Team Building, Coaching, Regulatory Affairs, Social Media, Business Development, Lifesciences, Strategy, Consulting, Sales Operations, Sales Process, Accounting, Project Planning, Medical Devices, Biotechnology, Engineering, Research, Auditing, Program Management, Networking
Education
Seton Hall University 2014 — 2016
Master of Business Administration (M.B.A.), Marketing
University of Kansas 2006 — 2011
Liberal Arts and Sciences, American Studies, Communication Studies
St. Ignatius College Prep 2002 — 2006
Seton Hall University August 2014 - Present
Seton Hall University- Stillman School of Business August 2014 - Present
Validant April 2012 - September 2013
University of Kansas Athletics August 2008 - May 2011
Skills
Recruiting, Training, Management, Team Building, Coaching, Regulatory Affairs, Social Media, Business Development, Lifesciences, Strategy, Consulting, Sales Operations, Sales Process, Accounting, Project Planning, Medical Devices, Biotechnology, Engineering, Research, Auditing, Program Management, Networking
Education
Seton Hall University 2014 — 2016
Master of Business Administration (M.B.A.), Marketing
University of Kansas 2006 — 2011
Liberal Arts and Sciences, American Studies, Communication Studies
St. Ignatius College Prep 2002 — 2006
Scott Edwards's Validant Experience November 2013 - July 2015
Job Director of Quality Assurance and Regulatory Affairs at AMD LASERS, an AMD GROUP LLC company
Industry Medical Devices
Experience
AMD LASERS, an AMD GROUP LLC company August 2015 - Present
Validant November 2013 - July 2015
Black Diamond Networks May 2013 - November 2013
Validant November 2012 - May 2013
Aircom Manufacturing May 2012 - November 2012
Beckman Coulter May 2011 - May 2012
Validant July 2010 - May 2011
Zimmer, Inc August 2008 - March 2010
Zimmer 2008 - 2010
Zimmer 2008 - 2010
Skills
CAPA, Medical Devices, Quality Systems, Process Validation, Manufacturing, V&V, Quality System, Quality Assurance, ISO 13485, Leadership, FDA, Training, Six Sigma, ISO, Continuous Improvement, Software Documentation, Project Management, Design Control, Design for Manufacturing, DMAIC, ISO 14971, Hardware Diagnostics, Manufacturing Operations, Business Development, Strategic Planning, Operating Budgets, Business Strategy, Business Process..., Personnel Management, Performance Improvement, International Business..., Cross-functional Team..., Organizational..., Production Process..., Validation, Sop, Manufacturing..., Process Improvement, Product Development, Engineering, Quality Control, Testing, GMP, Quality Auditing, FMEA, Computer System..., SOP, Change Control, Root Cause Analysis
Education
Purdue University 1984 — 1988
Bachelor of Science
AMD LASERS, an AMD GROUP LLC company August 2015 - Present
Validant November 2013 - July 2015
Black Diamond Networks May 2013 - November 2013
Validant November 2012 - May 2013
Aircom Manufacturing May 2012 - November 2012
Beckman Coulter May 2011 - May 2012
Validant July 2010 - May 2011
Zimmer, Inc August 2008 - March 2010
Zimmer 2008 - 2010
Zimmer 2008 - 2010
Skills
CAPA, Medical Devices, Quality Systems, Process Validation, Manufacturing, V&V, Quality System, Quality Assurance, ISO 13485, Leadership, FDA, Training, Six Sigma, ISO, Continuous Improvement, Software Documentation, Project Management, Design Control, Design for Manufacturing, DMAIC, ISO 14971, Hardware Diagnostics, Manufacturing Operations, Business Development, Strategic Planning, Operating Budgets, Business Strategy, Business Process..., Personnel Management, Performance Improvement, International Business..., Cross-functional Team..., Organizational..., Production Process..., Validation, Sop, Manufacturing..., Process Improvement, Product Development, Engineering, Quality Control, Testing, GMP, Quality Auditing, FMEA, Computer System..., SOP, Change Control, Root Cause Analysis
Education
Purdue University 1984 — 1988
Bachelor of Science
Andrew Conrad Andrew Conrad's Validant Experience December 2013 - Present
Job Post Market Surveillance Complaint Specialist at Validant
Industry Medical Devices
Experience
Validant December 2013 - Present
Synthes July 2012 - December 2013
Synthes September 2010 - July 2012
Synthes September 2009 - September 2010
Vector Marketing June 2008 - September 2008
Skills
Quality Assurance, Complaint Management, Medical Devices, Software Documentation, Troubleshooting, Process Improvement, Visio, Lean Manufacturing, Continuous Improvement, Technical Writing, Six Sigma, Quality Control, Customer Service, Manufacturing, Access, Electronics, Validation, Cross-functional Team..., Customer Satisfaction, Testing, Technical Support, ISO, Root Cause Analysis, FDA, Logistics, Process Optimization, Lean Thinking, Fish Philosophy, Highly detail oriented, Adaptability, Work Ethic, AutoCAD, Solidworks, Manufacturing..., Metallurgy, Training, Employee Training, Psychology, Sales
Education
Pennsylvania College of Technology 2005 — 2007
Associate's Degree, CAD/CADD Drafting and/or Design Technology/Technician
Great Valley High School 2001 — 2005
High School, 9th - 12th
Validant December 2013 - Present
Synthes July 2012 - December 2013
Synthes September 2010 - July 2012
Synthes September 2009 - September 2010
Vector Marketing June 2008 - September 2008
Skills
Quality Assurance, Complaint Management, Medical Devices, Software Documentation, Troubleshooting, Process Improvement, Visio, Lean Manufacturing, Continuous Improvement, Technical Writing, Six Sigma, Quality Control, Customer Service, Manufacturing, Access, Electronics, Validation, Cross-functional Team..., Customer Satisfaction, Testing, Technical Support, ISO, Root Cause Analysis, FDA, Logistics, Process Optimization, Lean Thinking, Fish Philosophy, Highly detail oriented, Adaptability, Work Ethic, AutoCAD, Solidworks, Manufacturing..., Metallurgy, Training, Employee Training, Psychology, Sales
Education
Pennsylvania College of Technology 2005 — 2007
Associate's Degree, CAD/CADD Drafting and/or Design Technology/Technician
Great Valley High School 2001 — 2005
High School, 9th - 12th
Eugenia (Jean) Poulos Eugenia (Jean) Poulos's Validant Experience April 2012 - June 2012
Job Vice President, Global Regulatory at Aceto Corporation
Industry Pharmaceuticals
Experience
Aceto Corporation, Rising Pharmaceticals subsidiary January 2014 - Present
Johnson & Johnson February 2013 - January 2014
Tunnell Consulting, Inc. June 2012 - February 2013
Validant April 2012 - June 2012
TUNNELL CONSULTING August 2011 - March 2012
LUITPOLD PHARMACEUTICALS INC May 2003 - June 2011
ICON LABORATORIES March 2002 - May 2003
BRISTOL-MYERS SQUIBB (formerly DUPONT PHARMACEUTICALS) February 1998 - March 2002
BRISTOL-MYERS SQUIBB (formerly DUPONT PHARMACEUTICALS ) May 1995 - February 1998
HI-TECH PHARMACAL CO, INC February 1994 - March 1995
Skills
Regulatory Affairs, Pharmaceutical Industry, Vaccines, Quality Assurance, Quality Control, Pharmaceutics, Change Control, CAPA, FDA, GMP, Validation, Regulatory Compliance, Solid Oral Dosage Forms, Parenteral, Sterility Assurance, Medical Devices, ISO 13485, Strategy, ISO, Regulatory Requirements, Biopharmaceuticals, Quality Auditing, Sop, Biotechnology, Root Cause Analysis, V&V, Compliance, Technology Transfer, Aseptic Processing, Quality System, R&D, Computer System..., Cross-functional Team...
Education
CW Post, LIU 2000 — 2004
MBA, Management
St. John's University 1977 — 1981
MS, Industrial Pharmacy
Aceto Corporation, Rising Pharmaceticals subsidiary January 2014 - Present
Johnson & Johnson February 2013 - January 2014
Tunnell Consulting, Inc. June 2012 - February 2013
Validant April 2012 - June 2012
TUNNELL CONSULTING August 2011 - March 2012
LUITPOLD PHARMACEUTICALS INC May 2003 - June 2011
ICON LABORATORIES March 2002 - May 2003
BRISTOL-MYERS SQUIBB (formerly DUPONT PHARMACEUTICALS) February 1998 - March 2002
BRISTOL-MYERS SQUIBB (formerly DUPONT PHARMACEUTICALS ) May 1995 - February 1998
HI-TECH PHARMACAL CO, INC February 1994 - March 1995
Skills
Regulatory Affairs, Pharmaceutical Industry, Vaccines, Quality Assurance, Quality Control, Pharmaceutics, Change Control, CAPA, FDA, GMP, Validation, Regulatory Compliance, Solid Oral Dosage Forms, Parenteral, Sterility Assurance, Medical Devices, ISO 13485, Strategy, ISO, Regulatory Requirements, Biopharmaceuticals, Quality Auditing, Sop, Biotechnology, Root Cause Analysis, V&V, Compliance, Technology Transfer, Aseptic Processing, Quality System, R&D, Computer System..., Cross-functional Team...
Education
CW Post, LIU 2000 — 2004
MBA, Management
St. John's University 1977 — 1981
MS, Industrial Pharmacy
Jaime Neumann Jaime Neumann's Validant Experience January 2014 - October 2014
Job Complaint Specialist at Prestige Brands, Inc.
Industry Medical Devices
Experience
Prestige Brands, Inc. October 2014 - Present
Otsuka Pharmaceutical Companies (U.S.) April 2014 - October 2014
Validant January 2014 - October 2014
Ethicon, Inc. January 2014 - March 2014
Novartis April 2013 - January 2014
Green Key Resources March 2013 - January 2014
Polymedco September 2012 - March 2013
Natural Organics Inc. April 2012 - August 2012
San-Mar Labs, Inc November 2003 - April 2012
SPAR Group, Inc. July 2000 - September 2003
Skills
Optimization, Project Coordination, Quality Assurance, GMP, Quality Systems, SOP, Quality Auditing, Analytical Abilities, Training & Development, Change Control, Quality Management..., Master Site Planning, Complaints, CAPA, Root Cause Analysis, Root Cause Problem..., Manufacturing..., 21 CFR Part 211, FDA GMP, FDA QUIST Practices, FDA Inspection Liaison, MSDS Documentation, Process Validation, Systems Organization, Batch Release, Batch Records, Dietary Supplement..., Dietary Supplement GMP, NSF Certification..., CA Prop 65 Compliance, Value Stream Mapping, SPC, Manufacturing, Sop, Reports, Quality System, GLP, Quality Management, 21 CFR Part 11, FDA, Medical Devices, V&V, Technology Transfer, Raw Materials, Analytical Chemistry, R&D, Quality Control, LIMS, Software Documentation, Pharmaceutical Industry
Education
Tusculum College 1985 — 1986
Prestige Brands, Inc. October 2014 - Present
Otsuka Pharmaceutical Companies (U.S.) April 2014 - October 2014
Validant January 2014 - October 2014
Ethicon, Inc. January 2014 - March 2014
Novartis April 2013 - January 2014
Green Key Resources March 2013 - January 2014
Polymedco September 2012 - March 2013
Natural Organics Inc. April 2012 - August 2012
San-Mar Labs, Inc November 2003 - April 2012
SPAR Group, Inc. July 2000 - September 2003
Skills
Optimization, Project Coordination, Quality Assurance, GMP, Quality Systems, SOP, Quality Auditing, Analytical Abilities, Training & Development, Change Control, Quality Management..., Master Site Planning, Complaints, CAPA, Root Cause Analysis, Root Cause Problem..., Manufacturing..., 21 CFR Part 211, FDA GMP, FDA QUIST Practices, FDA Inspection Liaison, MSDS Documentation, Process Validation, Systems Organization, Batch Release, Batch Records, Dietary Supplement..., Dietary Supplement GMP, NSF Certification..., CA Prop 65 Compliance, Value Stream Mapping, SPC, Manufacturing, Sop, Reports, Quality System, GLP, Quality Management, 21 CFR Part 11, FDA, Medical Devices, V&V, Technology Transfer, Raw Materials, Analytical Chemistry, R&D, Quality Control, LIMS, Software Documentation, Pharmaceutical Industry
Education
Tusculum College 1985 — 1986
Chol Yoon Chol Yoon's Validant Experience February 2012 - September 2014
Job Contractor at Novartis
Industry Pharmaceuticals
Experience
PRO Unlimited November 2014 - Present
Validant February 2012 - September 2014
Merck January 2010 - December 2011
Schering-Plough Research Institute January 2003 - December 2010
Siemens Healthcare November 1994 - June 2002
Skills
Manufacturing, Regulatory Affairs, Chromatography, HPLC, Microsoft Office, Interwise (Presentation..., GCM Trackwise..., Word, Excel, Access, Visio, Outlook, foreign languages korean, Spectrophotometry, Filtration, Titration, Sterile Manufacturing..., EtQ, Microsoft Excel, Pharmaceutical Industry, Change Management, GMP, SOP, Change Control, FDA, Quality Assurance, Training, POE, Continuous Improvement, Computer System..., Documentation
Education
San Jose State University 2000 — 2002
M.B.A., Master, Business Administration
San Francisco State University 1990 — 1994
B.S, Cell & Molecular Biology
San Francisco State University 1990 — 1994
B.A, Psychology
PRO Unlimited November 2014 - Present
Validant February 2012 - September 2014
Merck January 2010 - December 2011
Schering-Plough Research Institute January 2003 - December 2010
Siemens Healthcare November 1994 - June 2002
Skills
Manufacturing, Regulatory Affairs, Chromatography, HPLC, Microsoft Office, Interwise (Presentation..., GCM Trackwise..., Word, Excel, Access, Visio, Outlook, foreign languages korean, Spectrophotometry, Filtration, Titration, Sterile Manufacturing..., EtQ, Microsoft Excel, Pharmaceutical Industry, Change Management, GMP, SOP, Change Control, FDA, Quality Assurance, Training, POE, Continuous Improvement, Computer System..., Documentation
Education
San Jose State University 2000 — 2002
M.B.A., Master, Business Administration
San Francisco State University 1990 — 1994
B.S, Cell & Molecular Biology
San Francisco State University 1990 — 1994
B.A, Psychology
Timothy Tran Timothy Tran's Validant Experience August 2013 - April 2014
Job Game Content Manager
Industry Entertainment
Experience
TinyCo June 2015 - Present
Voltage Entertainment USA April 2014 - June 2015
Validant August 2013 - April 2014
AggieTV June 2012 - June 2013
Kaplan Test Prep and Admissions November 2010 - June 2013
USDA-ARS October 2011 - June 2012
UC Davis September 2011 - June 2012
AggieTV October 2010 - June 2012
The Imaginary Zebra March 2010 - June 2012
UC Davis Medical Center April 2010 - March 2011
Skills
Public Speaking, Photography, Microsoft Office, Marketing, Community Outreach, Photoshop, Final Cut Pro, Event Planning, Video, Teaching, Illustrator, Entertainment, Social Media, Technical Recruiting, Research, Microbiology, PowerPoint, Facebook, Project Planning, Project Management
Education
University of California, Davis
Bachelor of Science, Clinical Nutrition
Valley Christian High school
High School Diploma
TinyCo June 2015 - Present
Voltage Entertainment USA April 2014 - June 2015
Validant August 2013 - April 2014
AggieTV June 2012 - June 2013
Kaplan Test Prep and Admissions November 2010 - June 2013
USDA-ARS October 2011 - June 2012
UC Davis September 2011 - June 2012
AggieTV October 2010 - June 2012
The Imaginary Zebra March 2010 - June 2012
UC Davis Medical Center April 2010 - March 2011
Skills
Public Speaking, Photography, Microsoft Office, Marketing, Community Outreach, Photoshop, Final Cut Pro, Event Planning, Video, Teaching, Illustrator, Entertainment, Social Media, Technical Recruiting, Research, Microbiology, PowerPoint, Facebook, Project Planning, Project Management
Education
University of California, Davis
Bachelor of Science, Clinical Nutrition
Valley Christian High school
High School Diploma
Joshua Fishman Joshua Fishman's Validant Experience December 2012 - June 2015
Job Clinician Advocate at DocMatter
Industry Hospital & Health Care
Experience
DocMatter July 2015 - Present
Validant December 2012 - June 2015
BASIS Science September 2012 - December 2012
Abbott Vascular May 2011 - August 2011
Nordstrom May 2009 - December 2010
John Muir Health May 2010 - August 2010
San Ramon Regional Medical Center May 2009 - August 2009
Education
University of Colorado at Boulder 2008 — 2012
Bachelor of Arts (B.A.)
School for International Training 2011 — 2011
DocMatter July 2015 - Present
Validant December 2012 - June 2015
BASIS Science September 2012 - December 2012
Abbott Vascular May 2011 - August 2011
Nordstrom May 2009 - December 2010
John Muir Health May 2010 - August 2010
San Ramon Regional Medical Center May 2009 - August 2009
Education
University of Colorado at Boulder 2008 — 2012
Bachelor of Arts (B.A.)
School for International Training 2011 — 2011
Katie Phillips Katie Phillips's Validant Experience May 2013 - Present
Job Recruiting Manager at Validant
Industry Staffing and Recruiting
Experience
Validant May 2013 - Present
Validant October 2012 - May 2013
Validant May 2011 - October 2012
Nordstrom October 2005 - May 2011
Skills
Quality Assurance, Medical Devices, Validation, Sop, Pharmaceutical Industry, Process Improvement, Quality Auditing, Technical Recruiting, CAPA, Six Sigma, FDA, Cross-functional Team..., ISO 13485, Quality Management, Quality System, Manufacturing, Consulting, Recruiting, Change Control, Computer System..., GMP, R&D, Process Simulation, Biotechnology, V&V, DMAIC, SOP, GLP, Pharmaceutics, ISO, Strategy, 21 CFR Part 11, Clinical Trials, Regulatory Affairs, Auditing, GxP, Process Engineering, Cold Calling, Laboratory, Biopharmaceuticals, Lifesciences, Document Management, Sourcing, Continuous Improvement, Lean Manufacturing, Software Documentation, Testing, Minitab, Applicant Tracking...
Education
UCSB 2000 — 2004
B.A., Spanish, Chemistry minor
Validant May 2013 - Present
Validant October 2012 - May 2013
Validant May 2011 - October 2012
Nordstrom October 2005 - May 2011
Skills
Quality Assurance, Medical Devices, Validation, Sop, Pharmaceutical Industry, Process Improvement, Quality Auditing, Technical Recruiting, CAPA, Six Sigma, FDA, Cross-functional Team..., ISO 13485, Quality Management, Quality System, Manufacturing, Consulting, Recruiting, Change Control, Computer System..., GMP, R&D, Process Simulation, Biotechnology, V&V, DMAIC, SOP, GLP, Pharmaceutics, ISO, Strategy, 21 CFR Part 11, Clinical Trials, Regulatory Affairs, Auditing, GxP, Process Engineering, Cold Calling, Laboratory, Biopharmaceuticals, Lifesciences, Document Management, Sourcing, Continuous Improvement, Lean Manufacturing, Software Documentation, Testing, Minitab, Applicant Tracking...
Education
UCSB 2000 — 2004
B.A., Spanish, Chemistry minor
Armen John Armen John's Validant Experience August 2014 - October 2014
Job QA Specialist III Method Validation
Industry Pharmaceuticals
Experience
Gilead Sciences October 2014 - Present
Validant August 2014 - October 2014
Impax Laboratories November 2013 - August 2014
Medtronic June 2002 - December 2010
B. Braun Medical January 2002 - June 2002
Banner Pharmacaps May 1997 - July 2001
University of California los Angeles May 1996 - July 1996
Skills
HPLC/UPLC, GC, NMR, Wet Chemistry, Drug Eluting Stents, Equipment Qualification, Method Development, Formulation Chemistry, Scientific Writing, Cleaning Validation, Container Closure..., Extractables &..., Method Transfers, Documentation Practices, FTIR, UV-VIS, Software Validation, Method Validation, Gas Chromatography, V&V, UV/Vis, FDA, GMP
Education
University of California, Berkeley
Bachelor of Science (BS), Chemistry
Gilead Sciences October 2014 - Present
Validant August 2014 - October 2014
Impax Laboratories November 2013 - August 2014
Medtronic June 2002 - December 2010
B. Braun Medical January 2002 - June 2002
Banner Pharmacaps May 1997 - July 2001
University of California los Angeles May 1996 - July 1996
Skills
HPLC/UPLC, GC, NMR, Wet Chemistry, Drug Eluting Stents, Equipment Qualification, Method Development, Formulation Chemistry, Scientific Writing, Cleaning Validation, Container Closure..., Extractables &..., Method Transfers, Documentation Practices, FTIR, UV-VIS, Software Validation, Method Validation, Gas Chromatography, V&V, UV/Vis, FDA, GMP
Education
University of California, Berkeley
Bachelor of Science (BS), Chemistry
Paul Wanback Paul Wanback's Validant Experience January 2014 - August 2014
Job Pharmaceutical Consultant
Industry Pharmaceuticals
Experience
ALKU Consulting May 2015 - Present
Regulatory Compliance Associates Inc. October 2014 - March 2015
Validant January 2014 - August 2014
ABC Laboratories November 2011 - January 2014
Patheon Pharmaceutical July 2010 - May 2011
DSM Pharmaceutical January 2009 - July 2010
Norwich Pharmaceutical July 2007 - September 2008
Quality Chemical Laboratories May 2004 - January 2007
Pfizer July 2001 - January 2003
Skills
HPLC, UV/Vis, Validation, FTIR, Dissolution, Method Development, TOC, Viscosity, GMP, LIMS, Gas Chromatography, Analytical Chemistry, Sop, FDA, Pharmaceutical Industry, Chemistry, USP, Cleaning Validation, GLP, UV, GC-FID, GC-Headspace, Laboratory, Wet Chemistry, V&V, CAPA, ELISA, TLC, Quality Control, Assay Development, Organic Synthesis, Empower, Biochemistry, SOP
Education
S.U.N.Y Plattsburgh 2003 — 2004
Master of Arts, Natural Science
S.U.N.Y Plattsburgh 1998 — 2001
Bachelor of Science, Cellular Biochemistry
State University of New York College at Plattsburgh 1998 — 2001
BS, Cellular Biochemistry
ALKU Consulting May 2015 - Present
Regulatory Compliance Associates Inc. October 2014 - March 2015
Validant January 2014 - August 2014
ABC Laboratories November 2011 - January 2014
Patheon Pharmaceutical July 2010 - May 2011
DSM Pharmaceutical January 2009 - July 2010
Norwich Pharmaceutical July 2007 - September 2008
Quality Chemical Laboratories May 2004 - January 2007
Pfizer July 2001 - January 2003
Skills
HPLC, UV/Vis, Validation, FTIR, Dissolution, Method Development, TOC, Viscosity, GMP, LIMS, Gas Chromatography, Analytical Chemistry, Sop, FDA, Pharmaceutical Industry, Chemistry, USP, Cleaning Validation, GLP, UV, GC-FID, GC-Headspace, Laboratory, Wet Chemistry, V&V, CAPA, ELISA, TLC, Quality Control, Assay Development, Organic Synthesis, Empower, Biochemistry, SOP
Education
S.U.N.Y Plattsburgh 2003 — 2004
Master of Arts, Natural Science
S.U.N.Y Plattsburgh 1998 — 2001
Bachelor of Science, Cellular Biochemistry
State University of New York College at Plattsburgh 1998 — 2001
BS, Cellular Biochemistry
Matt Granger Matt Granger's Validant Experience February 2012 - April 2012
Job Project Lead / Senior Validation Engineer at Validation Technologies, Inc.
Industry Biotechnology
Experience
Validation Technologies, Inc. August 2014 - Present
Validation Technologies, Inc. April 2012 - August 2014
Validant February 2012 - April 2012
Hyde Engineering + Consulting May 2011 - August 2011
Pall Corporation August 2007 - July 2010
The Validation Company December 2006 - August 2007
Artes Medical February 2005 - August 2005
Biogen Idec August 2004 - December 2004
Skills
Engineering, Process Engineering, Validation, Cross-functional Team..., Manufacturing, Process Simulation, Software Documentation, Sop, V&V, Root Cause Analysis, Change Control, Biotechnology, Project Management, Testing, Chromatography, Technology Transfer, Quality Control, Quality Assurance, Filtration, GMP, Biopharmaceuticals, SOP
Education
University of California, San Diego 1999 — 2006
Bioengineering, Bioengineering & Design
La Jolla High School 1995 — 1999
Diploma, Physics
Validation Technologies, Inc. August 2014 - Present
Validation Technologies, Inc. April 2012 - August 2014
Validant February 2012 - April 2012
Hyde Engineering + Consulting May 2011 - August 2011
Pall Corporation August 2007 - July 2010
The Validation Company December 2006 - August 2007
Artes Medical February 2005 - August 2005
Biogen Idec August 2004 - December 2004
Skills
Engineering, Process Engineering, Validation, Cross-functional Team..., Manufacturing, Process Simulation, Software Documentation, Sop, V&V, Root Cause Analysis, Change Control, Biotechnology, Project Management, Testing, Chromatography, Technology Transfer, Quality Control, Quality Assurance, Filtration, GMP, Biopharmaceuticals, SOP
Education
University of California, San Diego 1999 — 2006
Bioengineering, Bioengineering & Design
La Jolla High School 1995 — 1999
Diploma, Physics
David A. White David A. White's Validant Experience April 2011 - August 2011
Job Contract Design Quality Engineer
Industry Medical Devices
Experience
Takeda Pharmaceuticals January 2015 - May 2015
St. Jude Medical August 2011 - December 2014
Validant April 2011 - August 2011
Terumo Cardiovascular Systems April 2011 - August 2011
Abbott Laboratories 2002 - 2010
Abbott Laboratories 1998 - 2002
Abbott Laboratories 1995 - 1998
Abbott Diagnostics 1984 - 1995
Skills
CAPA, Design Control, FDA, ISO 13485, Quality Assurance, Medical Devices, Risk Management, Quality Management, ISO 14971, Root Cause Analysis, Validation, Process Control, Quality System, R&D, Quality Control, GMP, Design of Experiments, Quality Auditing, V&V, Change Control, FMEA, Manufacturing, 21 CFR, DMAIC, SPC
Education
University of North Texas
Bachelor's degree, Biology, Genetics
Takeda Pharmaceuticals January 2015 - May 2015
St. Jude Medical August 2011 - December 2014
Validant April 2011 - August 2011
Terumo Cardiovascular Systems April 2011 - August 2011
Abbott Laboratories 2002 - 2010
Abbott Laboratories 1998 - 2002
Abbott Laboratories 1995 - 1998
Abbott Diagnostics 1984 - 1995
Skills
CAPA, Design Control, FDA, ISO 13485, Quality Assurance, Medical Devices, Risk Management, Quality Management, ISO 14971, Root Cause Analysis, Validation, Process Control, Quality System, R&D, Quality Control, GMP, Design of Experiments, Quality Auditing, V&V, Change Control, FMEA, Manufacturing, 21 CFR, DMAIC, SPC
Education
University of North Texas
Bachelor's degree, Biology, Genetics
Alex Kalionzes Alex Kalionzes's Validant Experience February 2014 - March 2014
Job Consultant at Quintiles
Industry Pharmaceuticals
Experience
Quintiles August 2015 - Present
Laboratory Validation Specialists Inc. March 2014 - August 2014
Validant February 2014 - March 2014
Oxford Global Resources May 2013 - October 2013
Laboratory Validation Specialists Inc. January 2012 - October 2012
Teva Pharmaceuticals April 2006 - June 2011
Bachem December 2004 - April 2006
Firmenich June 2004 - October 2004
Skills
LIMS, HPLC, Wet Chemistry, Chromatography, Gas Chromatography, Chemstation, USP, Analytical Chemistry, UV/Vis, GMP, Sop, 21 CFR part 210, 21 CFR Part 211, Training Laboratory..., Data Review/Approval, Laboratory Auditing, UV-Vis, TLC, IR, Titration, 21 CFR Part 11, cGMP, Empower, Laboratory, Chemistry, Cleaning Validation, Quality Control, NMR, Change Control, R&D, Quality System, Raw Materials, FTIR, GLP, Quality Assurance, Validation, Technology Transfer, Calibration, CAPA, FDA, SOP
Education
University of California, Santa Barbara 1994 — 1999
BS, Chemistry
Quintiles August 2015 - Present
Laboratory Validation Specialists Inc. March 2014 - August 2014
Validant February 2014 - March 2014
Oxford Global Resources May 2013 - October 2013
Laboratory Validation Specialists Inc. January 2012 - October 2012
Teva Pharmaceuticals April 2006 - June 2011
Bachem December 2004 - April 2006
Firmenich June 2004 - October 2004
Skills
LIMS, HPLC, Wet Chemistry, Chromatography, Gas Chromatography, Chemstation, USP, Analytical Chemistry, UV/Vis, GMP, Sop, 21 CFR part 210, 21 CFR Part 211, Training Laboratory..., Data Review/Approval, Laboratory Auditing, UV-Vis, TLC, IR, Titration, 21 CFR Part 11, cGMP, Empower, Laboratory, Chemistry, Cleaning Validation, Quality Control, NMR, Change Control, R&D, Quality System, Raw Materials, FTIR, GLP, Quality Assurance, Validation, Technology Transfer, Calibration, CAPA, FDA, SOP
Education
University of California, Santa Barbara 1994 — 1999
BS, Chemistry
Roland Bizanek's Validant Experience January 2015 - Present
Job Senior Consultant at Drug Development Resources
Industry Pharmaceuticals
Experience
Validant January 2015 - Present
Drug Development Resources September 2012 - Present
Compass Pharma Consulting, LLC September 2011 - Present
Anika Therapeutics July 2014 - January 2015
NextPharma July 2013 - April 2014
Complya Consulting Group January 2011 - April 2014
Ebewe Pharma December 2011 - December 2012
The Quantic Group, Ltd August 2011 - December 2012
AVEO Pharmaceuticals January 2011 - August 2011
Biogen Idec August 2007 - December 2010
Skills
Investigations, Compliance, Validation, Process Improvement, Process Optimization, Medical Devices, Regulatory Submissions, Continuous Improvement, Troubleshooting, Quality Assurance, Quality Management, Contract Manufacturing, GxP, Change Management, FDA, Quality Systems, Quality Auditing, Pharmaceuticals, Root Cause Analysis, Biotechnology, Operational Excellence, Problem Solving, Technology Transfer, Supplier Management, ISO 13485, GMP, Auditing, GCP, Clinical Trials, Regulatory Requirements, Quality System, Pharmaceutical Industry, 21 CFR Part 11, V&V, CAPA, Change Control, Biopharmaceuticals, Supply Management, Regulatory Affairs, Pharmaceutics, Computer System..., Sop, Clinical Development, GLP, Process Simulation, Manufacturing, LIMS, Aseptic Processing, Drug Development, R&D
Education
Northwestern University 2004 — 2006
Masters of Science, Product Development
University of Münster 1981 — 1990
Dr. rer. nat. (Ph.D.), Chemistry
Validant January 2015 - Present
Drug Development Resources September 2012 - Present
Compass Pharma Consulting, LLC September 2011 - Present
Anika Therapeutics July 2014 - January 2015
NextPharma July 2013 - April 2014
Complya Consulting Group January 2011 - April 2014
Ebewe Pharma December 2011 - December 2012
The Quantic Group, Ltd August 2011 - December 2012
AVEO Pharmaceuticals January 2011 - August 2011
Biogen Idec August 2007 - December 2010
Skills
Investigations, Compliance, Validation, Process Improvement, Process Optimization, Medical Devices, Regulatory Submissions, Continuous Improvement, Troubleshooting, Quality Assurance, Quality Management, Contract Manufacturing, GxP, Change Management, FDA, Quality Systems, Quality Auditing, Pharmaceuticals, Root Cause Analysis, Biotechnology, Operational Excellence, Problem Solving, Technology Transfer, Supplier Management, ISO 13485, GMP, Auditing, GCP, Clinical Trials, Regulatory Requirements, Quality System, Pharmaceutical Industry, 21 CFR Part 11, V&V, CAPA, Change Control, Biopharmaceuticals, Supply Management, Regulatory Affairs, Pharmaceutics, Computer System..., Sop, Clinical Development, GLP, Process Simulation, Manufacturing, LIMS, Aseptic Processing, Drug Development, R&D
Education
Northwestern University 2004 — 2006
Masters of Science, Product Development
University of Münster 1981 — 1990
Dr. rer. nat. (Ph.D.), Chemistry
Matt A Kramer, BA, CNMT, RT(NM)(CT)'s Validant Experience January 2015 - Present
Job Product Investigations Engineer at Validant
Industry Hospital & Health Care
Experience
Validant January 2015 - Present
Heart Care & Vascular Medicine, P A August 2014 - January 2015
WUESTHOFF MEMORIAL HOSPITAL, Health Management Associates, Rockledge September 2000 - December 2013
Temple University Health System October 1991 - September 2000
Temple University Hospital October 1989 - October 1991
Skills
Nuclear Medicine, Medical Imaging, PACS, Hospitals, Cardiology, Radiation Safety, Research, Quality Assurance, Molecular Imaging, Radiology, SPECT, Quality Control, Educational Leadership, RIS, Digital Imaging, Nuclear Cardiology, Radiopharmaceuticals, Clinical Research, Healthcare, ARRT CERTIFIED, NMTCB CERTIFIED, Nuclear Medicine..., Cardiovascular Imaging, Nuclear Safety, Publications, Computed Tomography, Medicine, HIPAA, Nuclear Pharmacy, ACR, Pediatrics, Radiation, ADVANCED CLINICAL..., Pediatric Imaging, CT CERTIFIED, Supervising, ARRT, BLS, Healthcare Information..., Teleradiology, DEXA, Medical Devices, Patient Safety, EHR
Education
Temple University 1982 — 1986
Bachelor's Degree, Biology, General
Temple University 1987 — 1989
Nuclear Medicine Technology, Diagnostic Molecular Imaging, A
Florida National University/MRI-CTEdGroup 2014 — 2014
Computed Tomography Certificate Program, CT & Certification for Intravenous Venipuncture for Contrast Media, A
Validant January 2015 - Present
Heart Care & Vascular Medicine, P A August 2014 - January 2015
WUESTHOFF MEMORIAL HOSPITAL, Health Management Associates, Rockledge September 2000 - December 2013
Temple University Health System October 1991 - September 2000
Temple University Hospital October 1989 - October 1991
Skills
Nuclear Medicine, Medical Imaging, PACS, Hospitals, Cardiology, Radiation Safety, Research, Quality Assurance, Molecular Imaging, Radiology, SPECT, Quality Control, Educational Leadership, RIS, Digital Imaging, Nuclear Cardiology, Radiopharmaceuticals, Clinical Research, Healthcare, ARRT CERTIFIED, NMTCB CERTIFIED, Nuclear Medicine..., Cardiovascular Imaging, Nuclear Safety, Publications, Computed Tomography, Medicine, HIPAA, Nuclear Pharmacy, ACR, Pediatrics, Radiation, ADVANCED CLINICAL..., Pediatric Imaging, CT CERTIFIED, Supervising, ARRT, BLS, Healthcare Information..., Teleradiology, DEXA, Medical Devices, Patient Safety, EHR
Education
Temple University 1982 — 1986
Bachelor's Degree, Biology, General
Temple University 1987 — 1989
Nuclear Medicine Technology, Diagnostic Molecular Imaging, A
Florida National University/MRI-CTEdGroup 2014 — 2014
Computed Tomography Certificate Program, CT & Certification for Intravenous Venipuncture for Contrast Media, A
Graelynn McKeown's Validant Experience September 2012 - January 2014
Job Manager, QA cGMP Training at Lannett Company
Industry Pharmaceuticals
Experience
Lannett Company February 2014 - Present
Validant September 2012 - January 2014
McNeil Consumer Healthcare September 2012 - January 2014
Charles River Laboratories November 2007 - February 2012
LPW Training Services 2012 - 2012
Novo Nordisk, Inc. November 2005 - October 2007
Arthur Murray International, Inc. August 2005 - June 2007
New Brunswick Public Schools - Adult Learning Center May 2003 - January 2005
Robert Wood Johnson University Hospital September 1999 - May 2003
Skills
Training Delivery, Adult Learning Theory, ADDIE, Instructor-led Training, Curriculum Development, E-Learning, Microsoft Office, Siebel, CRM, Cloud Applications, FDA, GLP, GMP, 21 CFR Part 11, Animal Welfare, Change Control, Biotechnology, Validation, Training Facilitation, Leadership, CRO, Sop, Pharmaceutical Industry, Training, Employee Training, Program Management, Clinical Development, Human Resources, Quality Assurance, Technical Writing, Technical Training, Articulate Storyline, Instructional Design, Onboarding, Needs Analysis, Learning Management, Captivate, Adult Education, Learning Management..., GxP, Blended Learning, Training Needs Analysis, SOP, Management
Education
Rutgers, The State University of New Jersey-New Brunswick
B.S., Biology
Lannett Company February 2014 - Present
Validant September 2012 - January 2014
McNeil Consumer Healthcare September 2012 - January 2014
Charles River Laboratories November 2007 - February 2012
LPW Training Services 2012 - 2012
Novo Nordisk, Inc. November 2005 - October 2007
Arthur Murray International, Inc. August 2005 - June 2007
New Brunswick Public Schools - Adult Learning Center May 2003 - January 2005
Robert Wood Johnson University Hospital September 1999 - May 2003
Skills
Training Delivery, Adult Learning Theory, ADDIE, Instructor-led Training, Curriculum Development, E-Learning, Microsoft Office, Siebel, CRM, Cloud Applications, FDA, GLP, GMP, 21 CFR Part 11, Animal Welfare, Change Control, Biotechnology, Validation, Training Facilitation, Leadership, CRO, Sop, Pharmaceutical Industry, Training, Employee Training, Program Management, Clinical Development, Human Resources, Quality Assurance, Technical Writing, Technical Training, Articulate Storyline, Instructional Design, Onboarding, Needs Analysis, Learning Management, Captivate, Adult Education, Learning Management..., GxP, Blended Learning, Training Needs Analysis, SOP, Management
Education
Rutgers, The State University of New Jersey-New Brunswick
B.S., Biology
Eoin Harrington Eoin Harrington's Validant Experience May 2010 - January 2012
Job SVP Quality & Innovation at Restoration Hardware
Industry Retail
Experience
Restoration Hardware January 2015 - Present
Restoration Hardware February 2012 - January 2015
Validant May 2010 - January 2012
Roche 2010 - 2010
Genentech INC. 2007 - 2010
Genentech INC. August 2000 - August 2005
Skills
Biopharmaceuticals, Biotechnology, FDA, Leadership, Project Management, Validation, Management, Cross-functional Team..., Social Media, GMP, V&V, Drug Development, Quality Assurance, Pharmaceutical Industry, Change Control, CAPA, Clinical Development, Social Media Marketing, GLP, Marketing, Strategy, Sop, Music Industry, Marketing Strategy, Lifesciences, Quality System, Strategic Planning, Start-ups, Medical Devices, Regulatory Affairs, 21 CFR Part 11, Computer System..., Program Management, Quality Auditing, Process Improvement, Technology Transfer
Education
University College Dublin 1995 — 1999
Bachelor's Degree, Chemical Engineering, Honors
Belvedere College, Dublin, Ireland
Restoration Hardware January 2015 - Present
Restoration Hardware February 2012 - January 2015
Validant May 2010 - January 2012
Roche 2010 - 2010
Genentech INC. 2007 - 2010
Genentech INC. August 2000 - August 2005
Skills
Biopharmaceuticals, Biotechnology, FDA, Leadership, Project Management, Validation, Management, Cross-functional Team..., Social Media, GMP, V&V, Drug Development, Quality Assurance, Pharmaceutical Industry, Change Control, CAPA, Clinical Development, Social Media Marketing, GLP, Marketing, Strategy, Sop, Music Industry, Marketing Strategy, Lifesciences, Quality System, Strategic Planning, Start-ups, Medical Devices, Regulatory Affairs, 21 CFR Part 11, Computer System..., Program Management, Quality Auditing, Process Improvement, Technology Transfer
Education
University College Dublin 1995 — 1999
Bachelor's Degree, Chemical Engineering, Honors
Belvedere College, Dublin, Ireland
Fauz Shere's Validant Experience June 2011 - October 2013
Job Compliance Excellence Champion
Industry Biotechnology
Experience
Baxter International Inc. March 2015 - Present
Lonza April 2014 - May 2014
Gilead Sciences June 2013 - October 2013
Validant June 2011 - October 2013
Validant June 2010 - April 2011
Amylin Pharmaceuticals February 2008 - February 2010
Genentech September 2005 - February 2008
Baxter International Inc. May 2002 - September 2005
Baxter International Inc. December 1999 - May 2002
NexStar Pharmaceuticals Inc March 1999 - October 1999
Skills
21 CFR Part 11, Aseptic Processing, Biotechnology, CAPA, Change Control, Design Control, FDA, GMP, Lifesciences, Manufacturing, Medical Devices, Microbiology, Pharmaceutical Industry, Process Improvement, Quality Assurance, Quality Control, Quality System, SOP, V, Validation, Sop, Testing, Life Sciences
Education
UCLA 1994 — 1998
Bachelor of Science, Microbiology & Molecular Genetics
Baxter International Inc. March 2015 - Present
Lonza April 2014 - May 2014
Gilead Sciences June 2013 - October 2013
Validant June 2011 - October 2013
Validant June 2010 - April 2011
Amylin Pharmaceuticals February 2008 - February 2010
Genentech September 2005 - February 2008
Baxter International Inc. May 2002 - September 2005
Baxter International Inc. December 1999 - May 2002
NexStar Pharmaceuticals Inc March 1999 - October 1999
Skills
21 CFR Part 11, Aseptic Processing, Biotechnology, CAPA, Change Control, Design Control, FDA, GMP, Lifesciences, Manufacturing, Medical Devices, Microbiology, Pharmaceutical Industry, Process Improvement, Quality Assurance, Quality Control, Quality System, SOP, V, Validation, Sop, Testing, Life Sciences
Education
UCLA 1994 — 1998
Bachelor of Science, Microbiology & Molecular Genetics
Gerard (Gerry) Mallon Gerard (Gerry) Mallon's Validant Experience July 2010 - July 2015
Job GPM Medical Device Consulting LLC
Industry Medical Devices
Experience
Global Medical Device Provider January 2015 - July 2015
Validant July 2010 - July 2015
Fresenius Medical Care December 2013 - January 2015
Fresenius Medical Care December 2013 - May 2014
Medtronic May 2013 - November 2013
Zimmer October 2012 - April 2013
Terumo CVS July 2011 - August 2012
Ortho Clinical Diagnostics February 2004 - January 2010
Ortho Clinical Diagnostics June 1999 - December 2003
Ortho Clinical Diagnostics 1997 - 1999
Skills
Six Sigma, Lean Manufacturing, Project Management, Product Quality, Organization, CAPA, ISO 13485, FDA, Medical Devices, Quality System, Design Control, Validation, Continuous Improvement, Quality Control, Manufacturing, ISO 14971, Process Improvement, Change Control, Quality Assurance, ISO, V&V, Product Development, Root Cause Analysis, GMP, DMAIC, Supplier Quality, Manufacturing..., 21 CFR Part 11, Minitab, Complaint Management, Manufacturing Operations, Hardware Diagnostics, FDA GMP, Gage R, Quality Management, Engineering Management, Design of Experiments, Black Belt, Quality Auditing, SPC, Sop, Computer System..., GxP, Iso 9000, Calibration, Process Simulation, R&D, Engineering, Value Stream Mapping, Regulatory Affairs
Education
Rochester Institute of Technology 1982 — 1986
Bachelor of Science Engineering Technology, Electrical and Electronics Engineering
Global Medical Device Provider January 2015 - July 2015
Validant July 2010 - July 2015
Fresenius Medical Care December 2013 - January 2015
Fresenius Medical Care December 2013 - May 2014
Medtronic May 2013 - November 2013
Zimmer October 2012 - April 2013
Terumo CVS July 2011 - August 2012
Ortho Clinical Diagnostics February 2004 - January 2010
Ortho Clinical Diagnostics June 1999 - December 2003
Ortho Clinical Diagnostics 1997 - 1999
Skills
Six Sigma, Lean Manufacturing, Project Management, Product Quality, Organization, CAPA, ISO 13485, FDA, Medical Devices, Quality System, Design Control, Validation, Continuous Improvement, Quality Control, Manufacturing, ISO 14971, Process Improvement, Change Control, Quality Assurance, ISO, V&V, Product Development, Root Cause Analysis, GMP, DMAIC, Supplier Quality, Manufacturing..., 21 CFR Part 11, Minitab, Complaint Management, Manufacturing Operations, Hardware Diagnostics, FDA GMP, Gage R, Quality Management, Engineering Management, Design of Experiments, Black Belt, Quality Auditing, SPC, Sop, Computer System..., GxP, Iso 9000, Calibration, Process Simulation, R&D, Engineering, Value Stream Mapping, Regulatory Affairs
Education
Rochester Institute of Technology 1982 — 1986
Bachelor of Science Engineering Technology, Electrical and Electronics Engineering
Paul McDaniel Paul McDaniel's Validant Experience February 2011 - Present
Job Design Assurance Subject Matter Expert at Fresenius Medical
Industry Medical Devices
Experience
Fresenius Medical Care January 2014 - Present
Validant February 2011 - Present
Fresenius Medical Care July 2013 - January 2014
Stryker Sustainability Solutions May 2012 - July 2013
Orion Health December 2011 - June 2012
Stryker August 2010 - November 2011
Sicel Technologies January 2005 - January 2011
Hill Rom January 1997 - January 2005
Hill Rom 1995 - 1997
Skills
Strategic Planning, Program Management, Risk Management, Operations Management, Process Improvement, Quality Systems, Quality System, Analysis, Business Process, CAPA, Continuous Improvement, Cross-functional Team..., Design Control, FDA, GMP, ISO, ISO 13485, ISO 14971, Integration, Leadership, Medical Devices, Product Development, Lean Manufacturing, Management, Management Consulting, Manufacturing, Quality Assurance, Quality Control, Supply Chain Management, Validation
Education
Strayer University 2007 — 2010
MBA, MBA Program
University of Kentucky 1979 — 1984
BS, Electrical Engineering
Fresenius Medical Care January 2014 - Present
Validant February 2011 - Present
Fresenius Medical Care July 2013 - January 2014
Stryker Sustainability Solutions May 2012 - July 2013
Orion Health December 2011 - June 2012
Stryker August 2010 - November 2011
Sicel Technologies January 2005 - January 2011
Hill Rom January 1997 - January 2005
Hill Rom 1995 - 1997
Skills
Strategic Planning, Program Management, Risk Management, Operations Management, Process Improvement, Quality Systems, Quality System, Analysis, Business Process, CAPA, Continuous Improvement, Cross-functional Team..., Design Control, FDA, GMP, ISO, ISO 13485, ISO 14971, Integration, Leadership, Medical Devices, Product Development, Lean Manufacturing, Management, Management Consulting, Manufacturing, Quality Assurance, Quality Control, Supply Chain Management, Validation
Education
Strayer University 2007 — 2010
MBA, MBA Program
University of Kentucky 1979 — 1984
BS, Electrical Engineering
Catherine Morgan Catherine Morgan's Validant Experience August 2010 - December 2011
Job Senior Engineer at Terumo Cardiovascular Systems
Industry Medical Devices
Experience
Terumo Cardiovascular Systems December 2011 - Present
Validant August 2010 - December 2011
ISSYS May 2004 - June 2010
University of Michigan August 2001 - May 2004
Sandia National Laboratories July 1999 - August 2001
TRW, Inc. June 1982 - June 1987
Skills
Medical Devices, MEMS, Labview, Sensors, Validation, Matlab, Analog, Manufacturing, R&D, LabVIEW, Quality System, Root Cause Analysis, Semiconductors, FMEA, Lean Manufacturing, Biomedical Engineering, Spectroscopy, Design of Experiments, FDA, ISO 13485, Design Control, Simulink
Education
University of Washington
Ph.D., Bioengineering
University of California, Los Angeles 1977 — 1982
BS, Electrical Engineering
Terumo Cardiovascular Systems December 2011 - Present
Validant August 2010 - December 2011
ISSYS May 2004 - June 2010
University of Michigan August 2001 - May 2004
Sandia National Laboratories July 1999 - August 2001
TRW, Inc. June 1982 - June 1987
Skills
Medical Devices, MEMS, Labview, Sensors, Validation, Matlab, Analog, Manufacturing, R&D, LabVIEW, Quality System, Root Cause Analysis, Semiconductors, FMEA, Lean Manufacturing, Biomedical Engineering, Spectroscopy, Design of Experiments, FDA, ISO 13485, Design Control, Simulink
Education
University of Washington
Ph.D., Bioengineering
University of California, Los Angeles 1977 — 1982
BS, Electrical Engineering
James Bentson James Bentson's Validant Experience August 2011 - April 2012
Job Sr Manager Risk Management and CAPA at Accuray
Industry Biotechnology
Experience
Accuray September 2014 - Present
Accuray September 2014 - May 2015
Johnson & Johnson September 2013 - September 2014
Johnson & Johnson April 2013 - September 2013
Wright Medical Technology August 2012 - April 2013
Validant August 2011 - April 2012
Validant Consulting August 2011 - April 2012
Terumo Cardiovascular Systems August 2011 - April 2012
Medtronic Ablation Frontiers LLC October 2009 - September 2010
Arbor Surgical 2003 - 2008
Skills
Engineering, Auditing, CAPA, Medical Devices, Process Validation, FDA, ISO standards, Production Management, Process Mapping, Process Development, Process Optimization, Regulatory Affairs, Quality Systems, Facilities Management, Quality Engineering, Product Development, Product Launches, Start-ups, V&V, Quality System, Quality Control, Manufacturing, Product Launch, Process Simulation, Root Cause Analysis, Quality Assurance, ISO 13485, Business Process Mapping, Design Control, Sop, Cross-functional Team..., Change Control, R&D, Quality Management, Manufacturing..., Software Documentation, Validation
Education
UCLA Anderson School of Management 1997 — 1997
Ccertificate, Group Dynamics
Wayne State University 1973 — 1978
Bachelor of Engineering (B.Eng.), Industrial Engineering
Accuray September 2014 - Present
Accuray September 2014 - May 2015
Johnson & Johnson September 2013 - September 2014
Johnson & Johnson April 2013 - September 2013
Wright Medical Technology August 2012 - April 2013
Validant August 2011 - April 2012
Validant Consulting August 2011 - April 2012
Terumo Cardiovascular Systems August 2011 - April 2012
Medtronic Ablation Frontiers LLC October 2009 - September 2010
Arbor Surgical 2003 - 2008
Skills
Engineering, Auditing, CAPA, Medical Devices, Process Validation, FDA, ISO standards, Production Management, Process Mapping, Process Development, Process Optimization, Regulatory Affairs, Quality Systems, Facilities Management, Quality Engineering, Product Development, Product Launches, Start-ups, V&V, Quality System, Quality Control, Manufacturing, Product Launch, Process Simulation, Root Cause Analysis, Quality Assurance, ISO 13485, Business Process Mapping, Design Control, Sop, Cross-functional Team..., Change Control, R&D, Quality Management, Manufacturing..., Software Documentation, Validation
Education
UCLA Anderson School of Management 1997 — 1997
Ccertificate, Group Dynamics
Wayne State University 1973 — 1978
Bachelor of Engineering (B.Eng.), Industrial Engineering
Ellen Golds Ellen Golds's Validant Experience June 2011 - January 2012
Job Owner, Golds Associates, LLC
Industry Medical Devices
Experience
Golds Associates, LLC 2001 - Present
Validant June 2011 - January 2012
AlvaMed, LLC August 2003 - June 2008
Renaltech 2000 - 2000
Boston Scientific Corp. 1997 - 2000
Datascope 1996 - 1997
US Surgical Corp 1992 - 1996
Baxter Healthcare 1984 - 1990
American Medical Systems September 1978 - September 1984
Skills
Project Management, Medical Device Product..., Medical Devices, Quality Systems, Product Development, Design Control, MS Project, Project Planning, Project Implementation, Program Management, Project Portfolio..., Expert Witness, Quality System, FDA, CAPA, R&D, GMP, Cross-functional Team..., Validation, Quality Management, 21 CFR Part 11, Pharmaceutical Industry, V&V, Quality Assurance, Commercialization, ISO 13485, ISO 14971, Manufacturing, Regulatory Affairs
Education
Northwestern University 1974 — 1978
BS BME
Golds Associates, LLC 2001 - Present
Validant June 2011 - January 2012
AlvaMed, LLC August 2003 - June 2008
Renaltech 2000 - 2000
Boston Scientific Corp. 1997 - 2000
Datascope 1996 - 1997
US Surgical Corp 1992 - 1996
Baxter Healthcare 1984 - 1990
American Medical Systems September 1978 - September 1984
Skills
Project Management, Medical Device Product..., Medical Devices, Quality Systems, Product Development, Design Control, MS Project, Project Planning, Project Implementation, Program Management, Project Portfolio..., Expert Witness, Quality System, FDA, CAPA, R&D, GMP, Cross-functional Team..., Validation, Quality Management, 21 CFR Part 11, Pharmaceutical Industry, V&V, Quality Assurance, Commercialization, ISO 13485, ISO 14971, Manufacturing, Regulatory Affairs
Education
Northwestern University 1974 — 1978
BS BME
Tatiana Shmeleva Tatiana Shmeleva's Validant Experience April 2014 - March 2015
Job Senior Software Quality Assurance Engineer at Philips Healthcare
Industry Biotechnology
Experience
Philips Healthcare April 2015 - Present
Validant April 2014 - March 2015
Genzyme July 2011 - March 2014
Boston Scientific May 2007 - July 2011
Skills
Quality Assurance, 21 CFR Part 11, Validation, Quality System, CAPA, FDA, Computer System..., Software Documentation, Change Control, GMP, 21 CFR, Quality Auditing, Testing, ISO 13485, SDLC, Medical Devices, Test Planning, Quality Systems, Software Quality..., Quality Management, Quality Control, ISO, Root Cause Analysis, Sop, Regulatory Affairs, Software Validation, Process Simulation, Quality Engineering, Software Quality, Continuous Improvement, Six Sigma, Process Improvement, Regulatory Submissions, Design Control, MS Project, Biotechnology, Test Methodologies, Documentation, Auditing, Technical Writing, User Acceptance Testing, Regulatory Requirements, Internal Audit, Compliance, Gap Analysis, Account Management, Project Management, SOP
Education
American Society for Quality 2010 — 2010
Quality Process Analyst
American Society for Quality 2009 — 2009
Quality Improvement Associate
Northeastern University 2008 — 2009
Ceritificate, Accounting
Herzen State University of Russia 1999 — 2003
BA, Psychology
Philips Healthcare April 2015 - Present
Validant April 2014 - March 2015
Genzyme July 2011 - March 2014
Boston Scientific May 2007 - July 2011
Skills
Quality Assurance, 21 CFR Part 11, Validation, Quality System, CAPA, FDA, Computer System..., Software Documentation, Change Control, GMP, 21 CFR, Quality Auditing, Testing, ISO 13485, SDLC, Medical Devices, Test Planning, Quality Systems, Software Quality..., Quality Management, Quality Control, ISO, Root Cause Analysis, Sop, Regulatory Affairs, Software Validation, Process Simulation, Quality Engineering, Software Quality, Continuous Improvement, Six Sigma, Process Improvement, Regulatory Submissions, Design Control, MS Project, Biotechnology, Test Methodologies, Documentation, Auditing, Technical Writing, User Acceptance Testing, Regulatory Requirements, Internal Audit, Compliance, Gap Analysis, Account Management, Project Management, SOP
Education
American Society for Quality 2010 — 2010
Quality Process Analyst
American Society for Quality 2009 — 2009
Quality Improvement Associate
Northeastern University 2008 — 2009
Ceritificate, Accounting
Herzen State University of Russia 1999 — 2003
BA, Psychology
Amy Winegarden Amy Winegarden's Validant Experience 2014 - Present
Job Professional Editor and Writer
Industry Writing and Editing
Experience
Validant 2014 - Present
Philips Healthcare November 2010 - April 2014
Philips Respironics November 2008 - June 2010
Respironics March 2006 - November 2008
Bondi Media July 2002 - March 2006
Skills
Editing, Technical Writing, Technical Documentation, Leadership, Regulatory Affairs, Design Control, Quality System..., Procedural Documentation, ISO 13485, 21 CFR, 21 CFR Part 11, FDA, FDA GMP, Document Lifecycle..., Quality Assurance, Medical Devices, Product Lifecycle..., Quality Documentation, Regulatory Documentation, Product Development, Harmonized Standards, Medical Device Directive, Unique Device..., CAPA, Creative Problem Solving, Positive Can-do Attitude, Communication Skills, Collaborative Problem..., Workshop Facilitation, Team Building, Workshop Development, Strategic Communications, Desktop Publishing, Proofreading, Copy Editing, Adobe Creative Suite, Multimedia, Public Speaking, Adobe Acrobat, Community Outreach, Non-profit Consulting, Fundraising, Visionary, Grant Writing, Creative Writing, Motivational Speaking, Building Relationships, Volunteer Management, Speech Writing, Philanthropy
Education
University of Pittsburgh
Bachelor of Arts (B.A.), Liberal Arts and Sciences, Concentration in English Communications
Validant 2014 - Present
Philips Healthcare November 2010 - April 2014
Philips Respironics November 2008 - June 2010
Respironics March 2006 - November 2008
Bondi Media July 2002 - March 2006
Skills
Editing, Technical Writing, Technical Documentation, Leadership, Regulatory Affairs, Design Control, Quality System..., Procedural Documentation, ISO 13485, 21 CFR, 21 CFR Part 11, FDA, FDA GMP, Document Lifecycle..., Quality Assurance, Medical Devices, Product Lifecycle..., Quality Documentation, Regulatory Documentation, Product Development, Harmonized Standards, Medical Device Directive, Unique Device..., CAPA, Creative Problem Solving, Positive Can-do Attitude, Communication Skills, Collaborative Problem..., Workshop Facilitation, Team Building, Workshop Development, Strategic Communications, Desktop Publishing, Proofreading, Copy Editing, Adobe Creative Suite, Multimedia, Public Speaking, Adobe Acrobat, Community Outreach, Non-profit Consulting, Fundraising, Visionary, Grant Writing, Creative Writing, Motivational Speaking, Building Relationships, Volunteer Management, Speech Writing, Philanthropy
Education
University of Pittsburgh
Bachelor of Arts (B.A.), Liberal Arts and Sciences, Concentration in English Communications
Patrick Cavana Patrick Cavana's Validant Experience March 2012 - December 2014
Job
Industry Pharmaceuticals
Experience
Validant March 2012 - December 2014
Johnson & Johnson Pharmaceutical Research & Development, L.L.C 2004 - 2007
ALZA Corporation 1997 - 2004
ALZA Corporation 1995 - 1997
ALZA Corporation 1994 - 1995
Lab Support, Inc April 1992 - January 1994
ALZA Corporation 1994 - 1994
Penederm, Inc November 1989 - October 1991
Skills
Cleaning Validation, GMP, Laboratory, Supplier Evaluation, Quality Control, Pharmaceutics, Training, CAPA, Change Control, Computer System..., Validation, Sop, FDA, Quality Assurance, Raw Materials, pharmacopeia, USP/NF, Analytical Method..., ICH-Quality Guidelines, Chromatography, UV/Vis, Chemistry, HPLC, Wet Chemistry, Gas Chromatography
Education
University of California, Santa Barbara 1985 — 1989
Bachelor of Science, Chemistry
Validant March 2012 - December 2014
Johnson & Johnson Pharmaceutical Research & Development, L.L.C 2004 - 2007
ALZA Corporation 1997 - 2004
ALZA Corporation 1995 - 1997
ALZA Corporation 1994 - 1995
Lab Support, Inc April 1992 - January 1994
ALZA Corporation 1994 - 1994
Penederm, Inc November 1989 - October 1991
Skills
Cleaning Validation, GMP, Laboratory, Supplier Evaluation, Quality Control, Pharmaceutics, Training, CAPA, Change Control, Computer System..., Validation, Sop, FDA, Quality Assurance, Raw Materials, pharmacopeia, USP/NF, Analytical Method..., ICH-Quality Guidelines, Chromatography, UV/Vis, Chemistry, HPLC, Wet Chemistry, Gas Chromatography
Education
University of California, Santa Barbara 1985 — 1989
Bachelor of Science, Chemistry
David Plescia's Validant Experience September 2014 - Present
Job Sr. Consultant, Medical Devices at Validant
Industry Medical Devices
Experience
Validant September 2014 - Present
Alcon Laboratories, Inc. September 2013 - September 2014
Terumo Cardiovascular Systems June 2011 - August 2013
Johnson & Johnson June 2004 - May 2011
YSI January 2000 - June 2004
Skills
Medical Devices, Design Control, Design of Experiments, Biomedical Engineering, ISO 13485, R&D, V&V, Quality System, Design for Manufacturing, Validation, Engineering, FDA, ISO 14971, SolidWorks, Patents, Innovation, Labview, Microcontrollers, FPGA, C++, C#, Matlab, Statistics, Design Verification..., Combination Products, Functional Verification, Drug Delivery
Education
University of Dayton 2000 — 2002
MSME, Mechanical Engineering
University of Dayton 1997 — 2000
BSME, Mechanical Engineering
The Catholic University of America 1995 — 1997
BSME, Biomedical Engineering
Validant September 2014 - Present
Alcon Laboratories, Inc. September 2013 - September 2014
Terumo Cardiovascular Systems June 2011 - August 2013
Johnson & Johnson June 2004 - May 2011
YSI January 2000 - June 2004
Skills
Medical Devices, Design Control, Design of Experiments, Biomedical Engineering, ISO 13485, R&D, V&V, Quality System, Design for Manufacturing, Validation, Engineering, FDA, ISO 14971, SolidWorks, Patents, Innovation, Labview, Microcontrollers, FPGA, C++, C#, Matlab, Statistics, Design Verification..., Combination Products, Functional Verification, Drug Delivery
Education
University of Dayton 2000 — 2002
MSME, Mechanical Engineering
University of Dayton 1997 — 2000
BSME, Mechanical Engineering
The Catholic University of America 1995 — 1997
BSME, Biomedical Engineering
Kim McClain-Gregal's Validant Experience 2011 - 2011
Job Quality Assurance Manager at ASO, LLC and Millennium Coating
Industry Medical Devices
Experience
ASO Worldwide January 2013 - Present
RedBubble March 2009 - Present
IDEX Corporation May 2012 - December 2012
none March 2011 - August 2011
Baxter Healthcare May 2008 - February 2011
Baxter Healthcare January 1999 - February 2011
Validant 2011 - 2011
Baxter Healthcare 2004 - 2008
ESI-Baxter 2002 - 2005
Baxter Healthcare 2004 - 2004
Skills
Quality System, Six Sigma, Cross-functional Team..., GMP, Pharmaceutical Industry, Quality Management, Quality Assurance, Sop, Lean Manufacturing, Medical Devices, FDA, ISO 13485, Process Improvement, Project Management, Process Simulation, Product Launch, CAPA, Product Development, Manufacturing, Quality Auditing, Design of Experiments, Engineering, Regulatory Affairs, ISO 14001, Design Control, Validation, Training, FMEA, R&D, ISO, Root Cause Analysis, Product Management, Team Leadership, Continuous Improvement, Testing, Iso 9000, Quality Control, Software Documentation, DMAIC, 21 CFR Part 11, SPC, Minitab, Change Control, Technical Writing, Supply Chain, Process Engineering, Management, Leadership, V&V, Biotechnology
Education
Purdue University 1982 — 1987
Bachelor's degree, Bioengineering and Biomedical Engineering
INDIANA UNIV. PURDUE UNIV. AT INDPLS (IUPUI)
B.S.E. Bioengineering, Mechanical Engineering
ASO Worldwide January 2013 - Present
RedBubble March 2009 - Present
IDEX Corporation May 2012 - December 2012
none March 2011 - August 2011
Baxter Healthcare May 2008 - February 2011
Baxter Healthcare January 1999 - February 2011
Validant 2011 - 2011
Baxter Healthcare 2004 - 2008
ESI-Baxter 2002 - 2005
Baxter Healthcare 2004 - 2004
Skills
Quality System, Six Sigma, Cross-functional Team..., GMP, Pharmaceutical Industry, Quality Management, Quality Assurance, Sop, Lean Manufacturing, Medical Devices, FDA, ISO 13485, Process Improvement, Project Management, Process Simulation, Product Launch, CAPA, Product Development, Manufacturing, Quality Auditing, Design of Experiments, Engineering, Regulatory Affairs, ISO 14001, Design Control, Validation, Training, FMEA, R&D, ISO, Root Cause Analysis, Product Management, Team Leadership, Continuous Improvement, Testing, Iso 9000, Quality Control, Software Documentation, DMAIC, 21 CFR Part 11, SPC, Minitab, Change Control, Technical Writing, Supply Chain, Process Engineering, Management, Leadership, V&V, Biotechnology
Education
Purdue University 1982 — 1987
Bachelor's degree, Bioengineering and Biomedical Engineering
INDIANA UNIV. PURDUE UNIV. AT INDPLS (IUPUI)
B.S.E. Bioengineering, Mechanical Engineering
Jeff Green Jeff Green's Validant Experience March 2008 - December 2009
Job President/Owner and Principal Consultant; (Medical Device and Pharma Industries)
Industry Medical Devices
Experience
Dohmen Life Science Services April 2015 - Present
DePuy/Synthes January 2013 - Present
DayBreak Solutions. LLC (Medical Device Consulting) January 2005 - Present
ProPharma Group September 2014 - January 2015
Quality Hub Limited May 2014 - August 2014
Ellissen Consulting GmbH April 2014 - May 2014
Quantic Group June 2009 - February 2013
Validant March 2008 - December 2009
RCA 2008 - 2009
Quintiles 2007 - 2008
Skills
FDA, CAPA, Medical Devices, Process Validation, ISO 13485, Consent Decree, QSR, ISO, GMP, Regulatory Affairs, Training, Diagnostic, Pharmaceutical Industry, Biopharmaceuticals, Quality System, Quality Assurance, 21 CFR Part 11, Start-ups, Design Control, Change Control, Quality Control, Quality Auditing, Biotechnology, GLP, V, Validation, Computer System..., Cross-functional Team..., Document Management, V&V
Education
University of South Carolina-Columbia 1962 — 1966
BS, Biology, Pre Med.
Dohmen Life Science Services April 2015 - Present
DePuy/Synthes January 2013 - Present
DayBreak Solutions. LLC (Medical Device Consulting) January 2005 - Present
ProPharma Group September 2014 - January 2015
Quality Hub Limited May 2014 - August 2014
Ellissen Consulting GmbH April 2014 - May 2014
Quantic Group June 2009 - February 2013
Validant March 2008 - December 2009
RCA 2008 - 2009
Quintiles 2007 - 2008
Skills
FDA, CAPA, Medical Devices, Process Validation, ISO 13485, Consent Decree, QSR, ISO, GMP, Regulatory Affairs, Training, Diagnostic, Pharmaceutical Industry, Biopharmaceuticals, Quality System, Quality Assurance, 21 CFR Part 11, Start-ups, Design Control, Change Control, Quality Control, Quality Auditing, Biotechnology, GLP, V, Validation, Computer System..., Cross-functional Team..., Document Management, V&V
Education
University of South Carolina-Columbia 1962 — 1966
BS, Biology, Pre Med.
Henry Urbach Henry Urbach's Validant Experience November 2013 - March 2014
Job GxP Training Specialist/Technical Writer/Principal Consultant
Industry Pharmaceuticals
Experience
Yoh, A Day & Zimmermann Company July 2014 - June 2015
Validant November 2013 - March 2014
Tunnell Consulting, Inc. February 2013 - September 2013
a-connect February 2012 - November 2012
Oriel STAT A MATRIX June 2011 - 2012
ImClone Systems, wholly-owned subsidiary of Eli Lilly & Co. August 2004 - October 2009
Wyeth October 2001 - November 2003
Wyeth January 1996 - October 2001
Teva Pharmaceuticals (formerly Biocraft Labs) September 1989 - January 1996
Baxter Healthcare, Microscan Division 1988 - 1989
Skills
GMP, cGMP practices, cGMP manufacturing, Training Delivery, Training Facilitation, SOP development, ICH guidelines, 21 cfr 211, CAPA, Quality Assurance, Environmental Monitoring, Environmental..., Training Effectiveness, Quality System..., Curriculum Development, Curriculum Assessment, Problem Solving, Presentation Coaching, Train the Trainer..., Project Management, Continuous Improvement, Training, FDA, Instructional Design, Auditing, Technology Transfer, Change Control, GLP, Pharmaceutical Industry, Lifesciences, 21 CFR Part 11, Validation, Quality System, Computer System..., Biotechnology, Biopharmaceuticals, Sop, Program Management, Quality Control, Laboratory, GxP, Regulatory Requirements, Microbiology, Cross-functional Team..., Quality Auditing, Quality Management, Operational Excellence
Education
William Paterson University of New Jersey 1990 — 1994
M.B.A., Management
Rutgers, The State University of New Jersey-Newark
B.A., Biology
North Bergen High School
Yoh, A Day & Zimmermann Company July 2014 - June 2015
Validant November 2013 - March 2014
Tunnell Consulting, Inc. February 2013 - September 2013
a-connect February 2012 - November 2012
Oriel STAT A MATRIX June 2011 - 2012
ImClone Systems, wholly-owned subsidiary of Eli Lilly & Co. August 2004 - October 2009
Wyeth October 2001 - November 2003
Wyeth January 1996 - October 2001
Teva Pharmaceuticals (formerly Biocraft Labs) September 1989 - January 1996
Baxter Healthcare, Microscan Division 1988 - 1989
Skills
GMP, cGMP practices, cGMP manufacturing, Training Delivery, Training Facilitation, SOP development, ICH guidelines, 21 cfr 211, CAPA, Quality Assurance, Environmental Monitoring, Environmental..., Training Effectiveness, Quality System..., Curriculum Development, Curriculum Assessment, Problem Solving, Presentation Coaching, Train the Trainer..., Project Management, Continuous Improvement, Training, FDA, Instructional Design, Auditing, Technology Transfer, Change Control, GLP, Pharmaceutical Industry, Lifesciences, 21 CFR Part 11, Validation, Quality System, Computer System..., Biotechnology, Biopharmaceuticals, Sop, Program Management, Quality Control, Laboratory, GxP, Regulatory Requirements, Microbiology, Cross-functional Team..., Quality Auditing, Quality Management, Operational Excellence
Education
William Paterson University of New Jersey 1990 — 1994
M.B.A., Management
Rutgers, The State University of New Jersey-Newark
B.A., Biology
North Bergen High School
Linda Peters's Validant Experience August 2015 - Present
Job Senior Vice President, Validant Healthcare
Industry Management Consulting
Experience
Validant August 2015 - Present
Baxter International, Inc. January 2011 - July 2015
MedImmune an AstraZeneca Company January 2005 - December 2010
Sequoia Pharmaceuticals, Inc. January 2007 - January 2010
Baxter Healthcare 2002 - 2005
Takeda Pharmaceuticals May 1999 - May 2002
TAP Pharmaceuticals 1995 - 1999
Searle 1994 - 1995
Skills
Vaccines, Biologics, Pharmaceutical Industry, Regulatory Affairs, Biotechnology, FDA, Regulatory Submissions, Clinical Development, Lifesciences, Clinical Trials, Medical Devices, Biopharmaceuticals, Infectious Diseases, Regulatory Requirements, Healthcare, Strategy, EMA, Organizational..., GMP, Drug Development, Commercialization, Change Management, GCP, Oncology, R&D, Technology Transfer, CAPA, CRO, Pharmaceutics, 21 CFR Part 11, IND, Change Control, GLP, Pharmacovigilance, Validation, Product Launch, Pharmaceutical Sales, Therapeutic Areas, Cardiology, Immunology, Sop, Regulations, CTMS, Market Access, Global Marketing, V&V, Medical Affairs, Sales Effectiveness, Managed Care, Life Sciences
Education
Northwestern University - Kellogg School of Management 2002 — 2004
MBA, Management, Marketing
Southern Illinois University, Carbondale
Master of Science (M.S.), Animal Science, Biochemistry
Southern Illinois University, Carbondale
Bachelor of Science (B.S.), Animal Science
Validant August 2015 - Present
Baxter International, Inc. January 2011 - July 2015
MedImmune an AstraZeneca Company January 2005 - December 2010
Sequoia Pharmaceuticals, Inc. January 2007 - January 2010
Baxter Healthcare 2002 - 2005
Takeda Pharmaceuticals May 1999 - May 2002
TAP Pharmaceuticals 1995 - 1999
Searle 1994 - 1995
Skills
Vaccines, Biologics, Pharmaceutical Industry, Regulatory Affairs, Biotechnology, FDA, Regulatory Submissions, Clinical Development, Lifesciences, Clinical Trials, Medical Devices, Biopharmaceuticals, Infectious Diseases, Regulatory Requirements, Healthcare, Strategy, EMA, Organizational..., GMP, Drug Development, Commercialization, Change Management, GCP, Oncology, R&D, Technology Transfer, CAPA, CRO, Pharmaceutics, 21 CFR Part 11, IND, Change Control, GLP, Pharmacovigilance, Validation, Product Launch, Pharmaceutical Sales, Therapeutic Areas, Cardiology, Immunology, Sop, Regulations, CTMS, Market Access, Global Marketing, V&V, Medical Affairs, Sales Effectiveness, Managed Care, Life Sciences
Education
Northwestern University - Kellogg School of Management 2002 — 2004
MBA, Management, Marketing
Southern Illinois University, Carbondale
Master of Science (M.S.), Animal Science, Biochemistry
Southern Illinois University, Carbondale
Bachelor of Science (B.S.), Animal Science
Karen Jean Charles Karen Jean Charles's Validant Experience March 2014 - Present
Job Training/Performance Improvement Consultant at Validant
Industry Pharmaceuticals
Experience
Validant March 2014 - Present
Skills
Pharmaceutical Industry, Quality Assurance, Training, GMP, FDA, Human Error Prevention, Human Performance..., Project Management, Articulate Storyline, Training Facilitation, Management, Instructional Design, Sop, Six Sigma, LIMS, Data Analysis, Chemistry, Pharmaceutics, Vaccines, HPLC, GLP, Biotechnology, Regulatory Affairs, Analytical Chemistry, Software Documentation, CAPA, Auditing, Troubleshooting, SOP
Education
Temple University
Master of Science, Quality Assurance; Regulatory Affairs
Temple University
Bachelor of Science, Chemistry
Temple University
Certificate, Clinical Trial Management2004
Validant March 2014 - Present
Skills
Pharmaceutical Industry, Quality Assurance, Training, GMP, FDA, Human Error Prevention, Human Performance..., Project Management, Articulate Storyline, Training Facilitation, Management, Instructional Design, Sop, Six Sigma, LIMS, Data Analysis, Chemistry, Pharmaceutics, Vaccines, HPLC, GLP, Biotechnology, Regulatory Affairs, Analytical Chemistry, Software Documentation, CAPA, Auditing, Troubleshooting, SOP
Education
Temple University
Master of Science, Quality Assurance; Regulatory Affairs
Temple University
Bachelor of Science, Chemistry
Temple University
Certificate, Clinical Trial Management2004
Madelaine Bess's Validant Experience September 2009 - June 2012
Job Assistant Account Manager at Grenadier
Industry Marketing and Advertising
Experience
Grenadier January 2015 - Present
Grenadier September 2014 - December 2014
Metrolist June 2013 - September 2013
University of Denver February 2013 - June 2013
Anthropologie June 2012 - January 2013
Validant September 2009 - June 2012
The Sink May 2007 - July 2009
Colorado Tobacco Education and Prevention Alliance January 2008 - May 2008
Lewis Bess Williams & Weese June 2007 - August 2007
Skills
Accounts Payable, Accounts Receivable, Microsoft Excel, Research, PowerPoint, QuickBooks, Customer Service, Accounting, Marketing, Social Media Marketing, Social Media, Microsoft Office, Microsoft Word, Time Management, Management, Sales, Training, Coaching, Fundraising, Event Planning
Education
University of Denver - Daniels College of Business 2012 — 2014
Master of Business Administration (M.B.A.), Marketing
University of Colorado at Boulder 2004 — 2008
Bachelor of Arts, Political Science; French
Grenadier January 2015 - Present
Grenadier September 2014 - December 2014
Metrolist June 2013 - September 2013
University of Denver February 2013 - June 2013
Anthropologie June 2012 - January 2013
Validant September 2009 - June 2012
The Sink May 2007 - July 2009
Colorado Tobacco Education and Prevention Alliance January 2008 - May 2008
Lewis Bess Williams & Weese June 2007 - August 2007
Skills
Accounts Payable, Accounts Receivable, Microsoft Excel, Research, PowerPoint, QuickBooks, Customer Service, Accounting, Marketing, Social Media Marketing, Social Media, Microsoft Office, Microsoft Word, Time Management, Management, Sales, Training, Coaching, Fundraising, Event Planning
Education
University of Denver - Daniels College of Business 2012 — 2014
Master of Business Administration (M.B.A.), Marketing
University of Colorado at Boulder 2004 — 2008
Bachelor of Arts, Political Science; French
Denise Grippo Denise Grippo's Validant Experience July 2012 - December 2012
Job Executive Director, GMP Quality at XenoPort, Inc.
Industry Pharmaceuticals
Experience
XenoPort, Inc. May 2015 - Present
Mylan December 2012 - May 2015
Validant July 2012 - December 2012
Watson Pharmaceuticals Inc. November 2011 - July 2012
Alvogen Inc./Norwich Pharmaceuticals Inc. January 2010 - November 2011
Norwich Pharmaceuticals, Inc. July 2008 - January 2010
Skills
Auditing, CAPA, GMP, Sop, FDA, 21 CFR Part 11, Validation, Quality System, Change Control, V&V, Regulatory Affairs, Pharmaceutical Industry, Cleaning Validation, GLP, Quality Auditing, Technology Transfer, Quality Assurance, Computer System..., Aseptic Processing, GxP, Process Improvement, Medical Devices, LIMS, Regulatory Submissions, Quality Management, Quality Control, Software Documentation, Biotechnology, GCP, Clinical Trials, Training, Lifesciences, Trackwise, Pharmacovigilance, Pharmaceutics, HPLC, Microbiology, Regulatory Requirements, Analytical Chemistry, Deviations, Contract Manufacturing, Root Cause Analysis, GAMP, Biopharmaceuticals, Design Control, Vaccines, ISO, Chromatography, Manufacturing, CRO
Education
University of Scranton 1998 — 2000
M.S., Clinical Chemistry
Temple University 1994 — 1998
B.S., Biology
XenoPort, Inc. May 2015 - Present
Mylan December 2012 - May 2015
Validant July 2012 - December 2012
Watson Pharmaceuticals Inc. November 2011 - July 2012
Alvogen Inc./Norwich Pharmaceuticals Inc. January 2010 - November 2011
Norwich Pharmaceuticals, Inc. July 2008 - January 2010
Skills
Auditing, CAPA, GMP, Sop, FDA, 21 CFR Part 11, Validation, Quality System, Change Control, V&V, Regulatory Affairs, Pharmaceutical Industry, Cleaning Validation, GLP, Quality Auditing, Technology Transfer, Quality Assurance, Computer System..., Aseptic Processing, GxP, Process Improvement, Medical Devices, LIMS, Regulatory Submissions, Quality Management, Quality Control, Software Documentation, Biotechnology, GCP, Clinical Trials, Training, Lifesciences, Trackwise, Pharmacovigilance, Pharmaceutics, HPLC, Microbiology, Regulatory Requirements, Analytical Chemistry, Deviations, Contract Manufacturing, Root Cause Analysis, GAMP, Biopharmaceuticals, Design Control, Vaccines, ISO, Chromatography, Manufacturing, CRO
Education
University of Scranton 1998 — 2000
M.S., Clinical Chemistry
Temple University 1994 — 1998
B.S., Biology
Dan Smelker-Cheeseman's Validant Experience May 2012 - August 2012
Job Learning & Development/LEAN Coordinator at BASF
Industry Chemicals
Experience
BASF August 2012 - Present
Validant May 2012 - August 2012
Bristol-Myers Squibb February 2010 - January 2012
MEI Rigging & Crating October 2008 - January 2010
Intel Corporation November 1995 - September 2007
Skills
Coaching, Continuous Improvement, Lean Manufacturing, Team Leadership, Safety Leadership, Training Coordination, Operational Streamlining, Teamwork, Teaching, Classroom Instruction, Process Improvement, Team Building, Leadership Development, Organizational..., Supervisory Skills, Problem Solving, Six Sigma, Team Management, Technical Writing, Manufacturing, Microsoft Office, Public Speaking, Documentation, ISO, Excel, Change Management, Word, Kaizen, Mentoring, Cost Reduction, 5S, Value Stream Mapping, Training Delivery, Operations Management, Instructional Design, Organizational Change, Staff Development, Performance Improvement, Technical Training, Training Skills, E-learning, Human Performance, Training, Software Documentation, E-Learning, Cross-functional Team..., Project Planning, Instructor-led Training, Performance Management, Analysis
Education
University of Phoenix 2008 — 2009
Masters of Arts, Adult Education and Training
DeVry University 2002 — 2004
Bachelor of Science, Technical Management (Project Management major)
DeVry University 1993 — 1995
Associate of Applied Science, Electronics Technology
Bridgman High School Bridgman, MI 1984 — 1988
High School Diploma, General
BASF August 2012 - Present
Validant May 2012 - August 2012
Bristol-Myers Squibb February 2010 - January 2012
MEI Rigging & Crating October 2008 - January 2010
Intel Corporation November 1995 - September 2007
Skills
Coaching, Continuous Improvement, Lean Manufacturing, Team Leadership, Safety Leadership, Training Coordination, Operational Streamlining, Teamwork, Teaching, Classroom Instruction, Process Improvement, Team Building, Leadership Development, Organizational..., Supervisory Skills, Problem Solving, Six Sigma, Team Management, Technical Writing, Manufacturing, Microsoft Office, Public Speaking, Documentation, ISO, Excel, Change Management, Word, Kaizen, Mentoring, Cost Reduction, 5S, Value Stream Mapping, Training Delivery, Operations Management, Instructional Design, Organizational Change, Staff Development, Performance Improvement, Technical Training, Training Skills, E-learning, Human Performance, Training, Software Documentation, E-Learning, Cross-functional Team..., Project Planning, Instructor-led Training, Performance Management, Analysis
Education
University of Phoenix 2008 — 2009
Masters of Arts, Adult Education and Training
DeVry University 2002 — 2004
Bachelor of Science, Technical Management (Project Management major)
DeVry University 1993 — 1995
Associate of Applied Science, Electronics Technology
Bridgman High School Bridgman, MI 1984 — 1988
High School Diploma, General
Heather Keller's Validant Experience April 2012 - April 2015
Job Vice President of Operations at Wollborg/Michelson
Industry Staffing and Recruiting
Experience
Wollborg/Michelson May 2015 - Present
Validant April 2012 - April 2015
On Assignment Lab Support February 2009 - April 2012
On Assignment Lab Support October 2002 - January 2009
Deltagen July 1999 - October 2002
Skills
Leadership, Talent Acquisition, Staffing Services, Kicking Ass, Recruiting, Operations Management, Interviews, Business Development, Quality Assurance, Training, Job Coaching, Talent Management, Medical Devices, GMP, Pharmaceutical Industry, Account Management, Cross-functional Team..., FDA, Strategy, Training & Development, Onboarding, Interview Coaching, Consulting, Contract Negotiation, Human Resources, Performance Management, Biotechnology, Technical Recruiting, Validation, Management
Education
University of California, Davis
BS, Biological Sciences
Wollborg/Michelson May 2015 - Present
Validant April 2012 - April 2015
On Assignment Lab Support February 2009 - April 2012
On Assignment Lab Support October 2002 - January 2009
Deltagen July 1999 - October 2002
Skills
Leadership, Talent Acquisition, Staffing Services, Kicking Ass, Recruiting, Operations Management, Interviews, Business Development, Quality Assurance, Training, Job Coaching, Talent Management, Medical Devices, GMP, Pharmaceutical Industry, Account Management, Cross-functional Team..., FDA, Strategy, Training & Development, Onboarding, Interview Coaching, Consulting, Contract Negotiation, Human Resources, Performance Management, Biotechnology, Technical Recruiting, Validation, Management
Education
University of California, Davis
BS, Biological Sciences
Jamie Degnan's Validant Experience November 2011 - April 2015
Job Account Executive at Front Desk, Inc
Industry Medical Devices
Experience
Front Desk, Inc April 2015 - Present
Validant November 2011 - April 2015
Focus Inc. (Acquired by Ziff Davis B2B) June 2010 - November 2011
Infineon Technologies, Inc February 2009 - June 2010
GEOS Language Corporation October 2007 - February 2009
Infineon Technologies, Inc June 2007 - September 2007
Infineon Technologies, Inc May 2006 - August 2006
Skills
Strategy, Sales, Market Research, Software Engineering, Product Management, Salesforce.com, Business Development, FDA, Medical Devices, Microsoft Excel, Recruiting, Marketing, PowerPoint, New Business Development, Product Development, Validation, Project Management, Project Planning
Education
University of Colorado at Boulder 2003 — 2007
Bachelor of Arts (B.A.), Communication
Semester at Sea 2005 — 2005
Entrepreneurship, World Politics
Front Desk, Inc April 2015 - Present
Validant November 2011 - April 2015
Focus Inc. (Acquired by Ziff Davis B2B) June 2010 - November 2011
Infineon Technologies, Inc February 2009 - June 2010
GEOS Language Corporation October 2007 - February 2009
Infineon Technologies, Inc June 2007 - September 2007
Infineon Technologies, Inc May 2006 - August 2006
Skills
Strategy, Sales, Market Research, Software Engineering, Product Management, Salesforce.com, Business Development, FDA, Medical Devices, Microsoft Excel, Recruiting, Marketing, PowerPoint, New Business Development, Product Development, Validation, Project Management, Project Planning
Education
University of Colorado at Boulder 2003 — 2007
Bachelor of Arts (B.A.), Communication
Semester at Sea 2005 — 2005
Entrepreneurship, World Politics
Will Nelson Will Nelson's Validant Experience March 2011 - December 2014
Job Senior Consultant with Cardinal Health Regulatory Sciences
Industry Pharmaceuticals
Experience
Cardinal Health Regulatory Sciences January 2015 - Present
Validant March 2011 - December 2014
Aptuit April 2010 - February 2011
Cedarburg Hauser Pharmaceuticals, Inc. March 2009 - February 2010
Boehringer Ingelheim Vetmedica October 2005 - March 2009
DSM Pharma Chemicals August 2002 - September 2005
Restoragen (BioNebraska) May 2001 - July 2002
Oread December 1996 - April 2001
Hauser August 1995 - December 1996
Oread September 1991 - August 1995
Skills
Process Validation, Validation, FDA, Regulatory Affairs, Quality Assurance, V&V, Cleaning Validation, Equipment Qualification, Consent Decree, Compliance Remediation, 21 CFR Part 11, GMP, Quality Management, GLP, Sop, Analytical Chemistry, Technology Transfer, Pharmaceutics, Drug Development, CAPA, Pharmaceutical Industry, Quality Control, GxP, Change Control, SOP
Education
University of Nebraska-Lincoln 1981 — 1986
Bachelor of Science, Chemistry
Cardinal Health Regulatory Sciences January 2015 - Present
Validant March 2011 - December 2014
Aptuit April 2010 - February 2011
Cedarburg Hauser Pharmaceuticals, Inc. March 2009 - February 2010
Boehringer Ingelheim Vetmedica October 2005 - March 2009
DSM Pharma Chemicals August 2002 - September 2005
Restoragen (BioNebraska) May 2001 - July 2002
Oread December 1996 - April 2001
Hauser August 1995 - December 1996
Oread September 1991 - August 1995
Skills
Process Validation, Validation, FDA, Regulatory Affairs, Quality Assurance, V&V, Cleaning Validation, Equipment Qualification, Consent Decree, Compliance Remediation, 21 CFR Part 11, GMP, Quality Management, GLP, Sop, Analytical Chemistry, Technology Transfer, Pharmaceutics, Drug Development, CAPA, Pharmaceutical Industry, Quality Control, GxP, Change Control, SOP
Education
University of Nebraska-Lincoln 1981 — 1986
Bachelor of Science, Chemistry
Gail Hamilton Gail Hamilton's Validant Experience April 2012 - September 2012
Job Quality Systems Consultant
Industry Medical Devices
Experience
Acclarent 2015 - 2015
Redbock February 2014 - September 2014
Black Diamond Networks January 2013 - December 2013
Reglera October 2012 - November 2012
Validant April 2012 - September 2012
Validant December 2011 - April 2012
Terumo Cardiovascular Systems 2012 - 2012
Generic Medical Devices, Inc. August 2009 - October 2011
Abbott Diagnostics August 2000 - November 2008
Johnson & Johnson Medical, Inc. August 1991 - August 2000
Skills
CAPA, ISO 13485, FDA, Medical Devices, Quality System, Validation, Design Control, V&V, GMP, Biotechnology, Regulatory Affairs, GLP, 21 CFR Part 11, Change Control
Education
Stephen F. Austin State University 1977 — 1980
B.S.
Acclarent 2015 - 2015
Redbock February 2014 - September 2014
Black Diamond Networks January 2013 - December 2013
Reglera October 2012 - November 2012
Validant April 2012 - September 2012
Validant December 2011 - April 2012
Terumo Cardiovascular Systems 2012 - 2012
Generic Medical Devices, Inc. August 2009 - October 2011
Abbott Diagnostics August 2000 - November 2008
Johnson & Johnson Medical, Inc. August 1991 - August 2000
Skills
CAPA, ISO 13485, FDA, Medical Devices, Quality System, Validation, Design Control, V&V, GMP, Biotechnology, Regulatory Affairs, GLP, 21 CFR Part 11, Change Control
Education
Stephen F. Austin State University 1977 — 1980
B.S.
Bill Schroeder's Validant Experience April 2013 - January 2014
Job Cleaning Validation SME/Consultant
Industry Biotechnology
Experience
Tunnell Consulting, Inc. March 2015 - July 2015
ALKU Technologies November 2014 - January 2015
Validation Technologies, Inc. March 2014 - September 2014
Validant April 2013 - January 2014
ProPharma Group February 2012 - March 2013
Pharmceutical Validation Solutions December 2007 - April 2012
Amgen January 2006 - October 2007
VaxGen June 2005 - November 2005
Boston Scientific, MN November 2004 - June 2005
various Ambulance Services June 1993 - August 2004
Skills
Cleaning Validation, Validation, Commissioning, Project Management, Technical Writing, Quality Assurance, Consent Decree..., Consent Decree, FDA, Change Control, V&V, Sop, GAMP, GLP, Aseptic Processing, Trackwise, GMP, CAPA, Computer System..., GxP, 21 CFR Part 11, Medical Devices, Biotechnology, Quality System
Education
Three Rivers Community College 1995 — 1996
Englewood Sr High School 1983 — 1986
HS Diploma
Tunnell Consulting, Inc. March 2015 - July 2015
ALKU Technologies November 2014 - January 2015
Validation Technologies, Inc. March 2014 - September 2014
Validant April 2013 - January 2014
ProPharma Group February 2012 - March 2013
Pharmceutical Validation Solutions December 2007 - April 2012
Amgen January 2006 - October 2007
VaxGen June 2005 - November 2005
Boston Scientific, MN November 2004 - June 2005
various Ambulance Services June 1993 - August 2004
Skills
Cleaning Validation, Validation, Commissioning, Project Management, Technical Writing, Quality Assurance, Consent Decree..., Consent Decree, FDA, Change Control, V&V, Sop, GAMP, GLP, Aseptic Processing, Trackwise, GMP, CAPA, Computer System..., GxP, 21 CFR Part 11, Medical Devices, Biotechnology, Quality System
Education
Three Rivers Community College 1995 — 1996
Englewood Sr High School 1983 — 1986
HS Diploma
Cynthia Adrean Cynthia Adrean's Validant Experience February 2010 - March 2011
Job Diagnostic Account Executive
Industry Medical Devices
Experience
BD March 2013 - Present
Becton, Dickinson and Company April 2011 - March 2013
Validant February 2010 - March 2011
Newton-Wellesley Hospital 2004 - 2009
Skills
Microbiology, Laboratory, Biotechnology, Validation, Project Management, Medical Devices, Lifesciences, Immunology, ELISA, Sales, PCR, Molecular Biology, Team Management
Education
University of Delaware 2003 — 2007
Bachelor of Science, Medical Technology
BD March 2013 - Present
Becton, Dickinson and Company April 2011 - March 2013
Validant February 2010 - March 2011
Newton-Wellesley Hospital 2004 - 2009
Skills
Microbiology, Laboratory, Biotechnology, Validation, Project Management, Medical Devices, Lifesciences, Immunology, ELISA, Sales, PCR, Molecular Biology, Team Management
Education
University of Delaware 2003 — 2007
Bachelor of Science, Medical Technology
Renan Estuardo Peña Renan Estuardo Peña's Validant Experience May 2014 - December 2014
Job Post Market Clinical and Pharmacovigilance Analyst – Team Lead at Oxford Global Resources
Industry Medical Devices
Experience
Oxford Global Resources June 2015 - Present
Black Diamond Networks February 2015 - July 2015
Validant May 2014 - December 2014
Maetrics, LLC September 2013 - May 2014
Medtronic May 2010 - September 2013
Skills
Medical Devices, Process Improvement, Troubleshooting, Software Documentation, FDA, Market Development, Customer Service, Management, Training, SAP, Cross-functional Team..., Quality System, Quality Assurance, CAPA, Six Sigma, GMP, Microsoft Office, Pharmaceutical Industry
Education
The University of Texas at San Antonio 2006 — 2012
Bachelor of Science (BS), Mechanical Engineering
Texas A&M University 2005 — 2006
Bachelor of Science (BS), Naval Architecture and Marine Engineering
Oxford Global Resources June 2015 - Present
Black Diamond Networks February 2015 - July 2015
Validant May 2014 - December 2014
Maetrics, LLC September 2013 - May 2014
Medtronic May 2010 - September 2013
Skills
Medical Devices, Process Improvement, Troubleshooting, Software Documentation, FDA, Market Development, Customer Service, Management, Training, SAP, Cross-functional Team..., Quality System, Quality Assurance, CAPA, Six Sigma, GMP, Microsoft Office, Pharmaceutical Industry
Education
The University of Texas at San Antonio 2006 — 2012
Bachelor of Science (BS), Mechanical Engineering
Texas A&M University 2005 — 2006
Bachelor of Science (BS), Naval Architecture and Marine Engineering
Derek Jaekle's Validant Experience June 2009 - January 2011
Job Helping IT Professionals Understand the Benefits of the Software Defined Data Center
Industry Information Technology and Services
Experience
VMware January 2014 - Present
VMware May 2012 - January 2014
Remedy Intelligent Staffing January 2012 - May 2012
Whitaker Medical March 2011 - December 2011
Validant June 2009 - January 2011
Fisher Investments September 2006 - June 2009
Silver Legacy Hotel & Casino June 2005 - August 2006
Arlington Clinical Pharmaceuticals March 2003 - July 2003
Skills
Sales, Recruiting, Microsoft Office, Cold Calling, Customer Service, Clinical Operations, Research, Leadership, Marketing, Microsoft Excel, Account Management, PowerPoint, Team Building, Microsoft Word, Training, Team Leadership, Applicant Tracking..., Negotiation, Social Media, VTSP, Analysis, Cloud Computing, CRM, Event Management, Sales Operations, Talent Acquisition, Networking, Management, Business Development, Sales Management, Talent Management, Interviews, Virtualization, Salesforce.com, New Business Development, Sales Process, Consulting, Direct Sales, Whiteboarding
Education
University of Nevada-Reno 2000 — 2006
Bachelor's Degree, Biology
VMware January 2014 - Present
VMware May 2012 - January 2014
Remedy Intelligent Staffing January 2012 - May 2012
Whitaker Medical March 2011 - December 2011
Validant June 2009 - January 2011
Fisher Investments September 2006 - June 2009
Silver Legacy Hotel & Casino June 2005 - August 2006
Arlington Clinical Pharmaceuticals March 2003 - July 2003
Skills
Sales, Recruiting, Microsoft Office, Cold Calling, Customer Service, Clinical Operations, Research, Leadership, Marketing, Microsoft Excel, Account Management, PowerPoint, Team Building, Microsoft Word, Training, Team Leadership, Applicant Tracking..., Negotiation, Social Media, VTSP, Analysis, Cloud Computing, CRM, Event Management, Sales Operations, Talent Acquisition, Networking, Management, Business Development, Sales Management, Talent Management, Interviews, Virtualization, Salesforce.com, New Business Development, Sales Process, Consulting, Direct Sales, Whiteboarding
Education
University of Nevada-Reno 2000 — 2006
Bachelor's Degree, Biology
ED Soliman's Validant Experience 2011 - 2013
Job Sr Technical Writer at Valeant Pharmaceuticals
Industry Pharmaceuticals
Experience
Pfizer June 2014 - September 2014
Valeant Pharmaceuticals September 2013 - May 2014
McNeil Consumer Healthcare 2011 - 2013
Validant 2011 - 2013
Validant 2011 - 2013
SCHERING-PLOUGH CORP (Merck) October 2003 - July 2006
SETARAM January 2001 - July 2003
Warner Lambert November 1986 - July 2000
Skills
Pharmaceutical Industry, GMP, FDA, Validation, Sop, Change Control, Manufacturing, Root Cause Analysis, Regulatory Affairs, Software Documentation, Technical Writing, CAPA, Chromatography, Pharmaceutics, Medical Devices, Training, SOP
Education
Fairleigh Dickinson University-Metropolitan Campus
Executive MBA
Purdue University
Master of Science (MSc), Nutrition
Rutgers University-New Brunswick
Doctor of Philosophy (PhD), Food Technology and Processing
Pfizer June 2014 - September 2014
Valeant Pharmaceuticals September 2013 - May 2014
McNeil Consumer Healthcare 2011 - 2013
Validant 2011 - 2013
Validant 2011 - 2013
SCHERING-PLOUGH CORP (Merck) October 2003 - July 2006
SETARAM January 2001 - July 2003
Warner Lambert November 1986 - July 2000
Skills
Pharmaceutical Industry, GMP, FDA, Validation, Sop, Change Control, Manufacturing, Root Cause Analysis, Regulatory Affairs, Software Documentation, Technical Writing, CAPA, Chromatography, Pharmaceutics, Medical Devices, Training, SOP
Education
Fairleigh Dickinson University-Metropolitan Campus
Executive MBA
Purdue University
Master of Science (MSc), Nutrition
Rutgers University-New Brunswick
Doctor of Philosophy (PhD), Food Technology and Processing
Theodore Hellen's Validant Experience 2012 - Present
Job Business Development Manager at Validant
Industry Pharmaceuticals
Experience
Validant 2012 - Present
Validant 2009 - 2012
Validant Consulting 2008 - 2009
Meridian Wealth Management February 2006 - February 2007
Skills
Business Development, Recruiting, Outsourcing, FDA, Quality System, Medical Devices, Validation, Regulatory Affairs, Biotechnology, CAPA, GMP, Pharmaceutical Industry, R&D, V&V, Quality Assurance, 21 CFR Part 11, Pharmaceutics, Program Management, ISO 13485, Change Control, Cross-functional Team..., Sop, Manufacturing, Quality Auditing, Talent Management, Clinical Trials, Six Sigma, Biopharmaceuticals, Quality Management, Quality Control, Technology Transfer, Regulatory Submissions, Root Cause Analysis, Consulting, Computer System..., ISO, Lifesciences, Process Simulation, Technical Recruiting, DMAIC, GxP, Process Improvement, Contract Recruitment, GLP, Design Control, Drug Development, Vaccines
Education
University of Colorado Boulder 2003 — 2007
BS Business Administration, Finance, Management
Validant 2012 - Present
Validant 2009 - 2012
Validant Consulting 2008 - 2009
Meridian Wealth Management February 2006 - February 2007
Skills
Business Development, Recruiting, Outsourcing, FDA, Quality System, Medical Devices, Validation, Regulatory Affairs, Biotechnology, CAPA, GMP, Pharmaceutical Industry, R&D, V&V, Quality Assurance, 21 CFR Part 11, Pharmaceutics, Program Management, ISO 13485, Change Control, Cross-functional Team..., Sop, Manufacturing, Quality Auditing, Talent Management, Clinical Trials, Six Sigma, Biopharmaceuticals, Quality Management, Quality Control, Technology Transfer, Regulatory Submissions, Root Cause Analysis, Consulting, Computer System..., ISO, Lifesciences, Process Simulation, Technical Recruiting, DMAIC, GxP, Process Improvement, Contract Recruitment, GLP, Design Control, Drug Development, Vaccines
Education
University of Colorado Boulder 2003 — 2007
BS Business Administration, Finance, Management
Gerard Dunn Gerard Dunn's Validant Experience November 2014 - August 2015
Job Independent Consultant
Industry Biotechnology
Experience
Validant November 2014 - August 2015
Philips November 1998 - January 2014
Bon Secours Health System June 1994 - November 1998
Sentara Healthcare March 1989 - January 1998
US Army March 1984 - January 1989
Skills
Medical Imaging, PACS, DICOM, Digital Imaging, Radiology, Medical Devices, RIS, Biomedical Engineering, X-ray, Nuclear Medicine, Hardware Diagnostics, Healthcare Information..., Hospitals, Healthcare, Field Service, MRI, Cardiology, HL7, Microsoft Office, Microsoft Excel, Microsoft Word, HIPAA, Computed Tomography, CompTIA, Instructor-led Training, Employee Training, Hands-on Training, Medical Education, Elementary Education
Education
Old Dominion University 1991 — 1994
BS, Nuclear Medicine
Tidewater Community College 1989 — 1991
AAS, Radiologic Technology
Validant November 2014 - August 2015
Philips November 1998 - January 2014
Bon Secours Health System June 1994 - November 1998
Sentara Healthcare March 1989 - January 1998
US Army March 1984 - January 1989
Skills
Medical Imaging, PACS, DICOM, Digital Imaging, Radiology, Medical Devices, RIS, Biomedical Engineering, X-ray, Nuclear Medicine, Hardware Diagnostics, Healthcare Information..., Hospitals, Healthcare, Field Service, MRI, Cardiology, HL7, Microsoft Office, Microsoft Excel, Microsoft Word, HIPAA, Computed Tomography, CompTIA, Instructor-led Training, Employee Training, Hands-on Training, Medical Education, Elementary Education
Education
Old Dominion University 1991 — 1994
BS, Nuclear Medicine
Tidewater Community College 1989 — 1991
AAS, Radiologic Technology
Dr. Ali Mehrabi Dr. Ali Mehrabi's Validant Experience November 2014 - Present
Job Senior Regulatory Affairs Consultant at Validant
Industry Medical Devices
Experience
Validant November 2014 - Present
Johnson and Johnson, DuPuy Synthes July 2013 - November 2014
Johnson and Johnson, Ethicon Endo-Surgery 2013 - 2013
E4D Technologies, Inc. 2012 - 2013
Insight Consulting Services 2000 - 2013
U.S. Food and Drug Administration January 2008 - December 2012
DeVry University May 2004 - May 2008
Radiance Technologies, Inc. 2002 - 2004
InTank, Inc. 2001 - 2002
JDS Uniphase 2000 - 2001
Skills
Biomedical Engineering, Matlab, Program Management, Engineering, Software Development, Product Development, Quality Assurance, Requirements Analysis, C, Software Documentation, SDLC, Team Leadership
Education
University of Oklahoma
Ph.D., Electrical Engineering
Oklahoma State University 1985 — 1986
Master of Science, Electrical Engineering
Validant November 2014 - Present
Johnson and Johnson, DuPuy Synthes July 2013 - November 2014
Johnson and Johnson, Ethicon Endo-Surgery 2013 - 2013
E4D Technologies, Inc. 2012 - 2013
Insight Consulting Services 2000 - 2013
U.S. Food and Drug Administration January 2008 - December 2012
DeVry University May 2004 - May 2008
Radiance Technologies, Inc. 2002 - 2004
InTank, Inc. 2001 - 2002
JDS Uniphase 2000 - 2001
Skills
Biomedical Engineering, Matlab, Program Management, Engineering, Software Development, Product Development, Quality Assurance, Requirements Analysis, C, Software Documentation, SDLC, Team Leadership
Education
University of Oklahoma
Ph.D., Electrical Engineering
Oklahoma State University 1985 — 1986
Master of Science, Electrical Engineering
Sean Scott Sean Scott's Validant Experience November 2011 - April 2014
Job Regional Business Development Manager at Oxford Healthcare IT
Industry Hospital & Health Care
Experience
Oxford Healthcare IT August 2015 - Present
CSols Inc. July 2014 - May 2015
Validant November 2011 - April 2014
Datatrial January 2009 - June 2011
Inclinix, Inc. March 2007 - December 2008
Skills
Analytical Chemistry, Medical Devices, Statistical Modeling, Pharmaceutical Industry, FDA, Biotechnology, Regulatory Affairs, Clinical Trials, EDC, GMP, GLP, CRO, Lifesciences, Quality System, Clinical Development, Sop, Regulatory Submissions, R&D, Technology Transfer, Validation, Pharmaceutics, CAPA, 21 CFR Part 11, Drug Development, Biopharmaceuticals, V&V, Change Control, Regulatory Requirements, Life Sciences, SOP
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2012 — 2014
Master of Business Administration (M.B.A.), Leadership and Strategy
University of Minnesota-Twin Cities 1998 — 2001
BS, Chemistry
Oxford Healthcare IT August 2015 - Present
CSols Inc. July 2014 - May 2015
Validant November 2011 - April 2014
Datatrial January 2009 - June 2011
Inclinix, Inc. March 2007 - December 2008
Skills
Analytical Chemistry, Medical Devices, Statistical Modeling, Pharmaceutical Industry, FDA, Biotechnology, Regulatory Affairs, Clinical Trials, EDC, GMP, GLP, CRO, Lifesciences, Quality System, Clinical Development, Sop, Regulatory Submissions, R&D, Technology Transfer, Validation, Pharmaceutics, CAPA, 21 CFR Part 11, Drug Development, Biopharmaceuticals, V&V, Change Control, Regulatory Requirements, Life Sciences, SOP
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2012 — 2014
Master of Business Administration (M.B.A.), Leadership and Strategy
University of Minnesota-Twin Cities 1998 — 2001
BS, Chemistry
Jeffrey Phan Jeffrey Phan's Validant Experience June 2012 - April 2013
Job Senior Consultant/Project Manager
Industry Pharmaceuticals
Experience
Pharmatech Associates December 2014 - Present
Pharmatech Associates, at Thermo Fisher Scientific April 2014 - November 2014
Pharmatech Associates, at Innovent Biologics November 2013 - April 2014
Pharmatech Associates, at Hybio Pharmaceuticals May 2013 - November 2013
Validant June 2012 - April 2013
Pharmatech Associates May 2011 - June 2012
Novartis Vaccines and Diagnostics April 2008 - March 2011
Novartis June 2006 - April 2008
Chiron Corporation June 2003 - May 2006
Bayer Berkeley December 2000 - June 2003
Skills
Validation, Risk Assessment, Deviation..., CAPA, Quality by Design, Project Management, FDA, Change Control, V&V, Quality Auditing, Commissioning, 21 CFR Part 11, Computer System..., GMP, GxP, Deviations, Cleaning Validation, Continuous Improvement, Process Improvement, Technology Transfer, Quality Control, Cross-functional Team..., Manufacturing, Quality System, Sop, Medical Devices, ISO 13485, Pharmaceutical Industry, LIMS, Biopharmaceuticals, Aseptic Processing, GAMP, Regulatory Affairs, Engineering, Quality Assurance, Design Control, Design of Experiments, Lean Manufacturing, Process Simulation, Trackwise, Regulatory Submissions, ISO, Biotechnology, Quality Management, Root Cause Analysis, Regulatory Requirements, Lifesciences, GLP, Pharmaceutics, R&D
Education
University of Arkansas
Industrial Engineering
Pharmatech Associates December 2014 - Present
Pharmatech Associates, at Thermo Fisher Scientific April 2014 - November 2014
Pharmatech Associates, at Innovent Biologics November 2013 - April 2014
Pharmatech Associates, at Hybio Pharmaceuticals May 2013 - November 2013
Validant June 2012 - April 2013
Pharmatech Associates May 2011 - June 2012
Novartis Vaccines and Diagnostics April 2008 - March 2011
Novartis June 2006 - April 2008
Chiron Corporation June 2003 - May 2006
Bayer Berkeley December 2000 - June 2003
Skills
Validation, Risk Assessment, Deviation..., CAPA, Quality by Design, Project Management, FDA, Change Control, V&V, Quality Auditing, Commissioning, 21 CFR Part 11, Computer System..., GMP, GxP, Deviations, Cleaning Validation, Continuous Improvement, Process Improvement, Technology Transfer, Quality Control, Cross-functional Team..., Manufacturing, Quality System, Sop, Medical Devices, ISO 13485, Pharmaceutical Industry, LIMS, Biopharmaceuticals, Aseptic Processing, GAMP, Regulatory Affairs, Engineering, Quality Assurance, Design Control, Design of Experiments, Lean Manufacturing, Process Simulation, Trackwise, Regulatory Submissions, ISO, Biotechnology, Quality Management, Root Cause Analysis, Regulatory Requirements, Lifesciences, GLP, Pharmaceutics, R&D
Education
University of Arkansas
Industrial Engineering
David Rosario David Rosario's Validant Experience June 2012 - September 2012
Job AR Specialist at OpenTable
Industry Accounting
Experience
OpenTable September 2012 - Present
THE PHOTO RIOT September 2009 - Present
Validant June 2012 - September 2012
Acrobat Outsourcing May 2012 - June 2012
Able Services March 2012 - May 2012
Legal Aid Society Employment Law Center January 2012 - February 2012
PwC January 2011 - March 2011
Hitachi GST July 2010 - December 2010
Brocade April 2010 - May 2010
ActionLink August 2006 - April 2009
Skills
Accounting, Accounts Receivable, Payroll, Invoicing, Auditing, Microsoft Excel, Financial Reporting, Tax, Facebook
Education
San Jose State University 2004 — 2009
Bachelor of Science in Business Administration, Accounting
Bellarmine College Preparatory 2000 — 2004
OpenTable September 2012 - Present
THE PHOTO RIOT September 2009 - Present
Validant June 2012 - September 2012
Acrobat Outsourcing May 2012 - June 2012
Able Services March 2012 - May 2012
Legal Aid Society Employment Law Center January 2012 - February 2012
PwC January 2011 - March 2011
Hitachi GST July 2010 - December 2010
Brocade April 2010 - May 2010
ActionLink August 2006 - April 2009
Skills
Accounting, Accounts Receivable, Payroll, Invoicing, Auditing, Microsoft Excel, Financial Reporting, Tax, Facebook
Education
San Jose State University 2004 — 2009
Bachelor of Science in Business Administration, Accounting
Bellarmine College Preparatory 2000 — 2004
Diane Moore's Validant Experience July 2010 - October 2012
Job Project Leader at DePuy Orthopaedics
Industry Medical Devices
Experience
DePuy Synthes Orthopaedics October 2012 - Present
Validant July 2010 - October 2012
Biomet Microfixation July 2007 - May 2010
Vistakon January 2001 - July 2007
Vistakon October 1989 - January 2001
Excel Meat Packing Corp January 1981 - September 1989
Skills
Change Control, Medical Devices, Data Mining, Kaizen Facilitation, CAPA, Quality Systems, Validation, SPC, Quality Assurance, FDA, Manufacturing, Process Validation, ISO 13485, GMP, Six Sigma, Continuous Improvement, Lean Manufacturing, Process Improvement, Documentation, Compliance, Problem Solving, Quality Management, Software Validation, Change Management, DMAIC, 21 CFR Part 11, Packaging, Microsoft Office, Computer System..., Minitab, Kaizen, Negotiation, Statistics, Testing, Process Development, Quality System, Cross-functional Team..., Design Control, Software Documentation
Education
Webster University 1998 — 2000
MA, Management/Information Management
Oklahoma State University 1976 — 1980
Bachelor of Science, Animal Scienc
DePuy Synthes Orthopaedics October 2012 - Present
Validant July 2010 - October 2012
Biomet Microfixation July 2007 - May 2010
Vistakon January 2001 - July 2007
Vistakon October 1989 - January 2001
Excel Meat Packing Corp January 1981 - September 1989
Skills
Change Control, Medical Devices, Data Mining, Kaizen Facilitation, CAPA, Quality Systems, Validation, SPC, Quality Assurance, FDA, Manufacturing, Process Validation, ISO 13485, GMP, Six Sigma, Continuous Improvement, Lean Manufacturing, Process Improvement, Documentation, Compliance, Problem Solving, Quality Management, Software Validation, Change Management, DMAIC, 21 CFR Part 11, Packaging, Microsoft Office, Computer System..., Minitab, Kaizen, Negotiation, Statistics, Testing, Process Development, Quality System, Cross-functional Team..., Design Control, Software Documentation
Education
Webster University 1998 — 2000
MA, Management/Information Management
Oklahoma State University 1976 — 1980
Bachelor of Science, Animal Scienc
Ernesto Díaz-Rivera Ernesto Díaz-Rivera's Validant Experience February 2015 - April 2015
Job Senior Consultant
Industry Management Consulting
Experience
Validant February 2015 - April 2015
Puerto Rico Department of Health October 2014 - March 2015
Oxford International January 2015 - January 2015
LabChemS Corp December 2014 - December 2014
Puerto Rico Small Business Development Center January 2013 - August 2014
Stryker September 2013 - December 2013
Becton Dickinson January 2012 - October 2012
Novartis Consumer Health September 2010 - January 2012
Warner Chilcott February 2002 - October 2010
Wyeth 2001 - 2001
Skills
FDA, CAPA, GMP, Validation, Sop, Quality System, Quality Control, Regulatory Requirements, 21 CFR Part 11, ISO 13485, GxP, Computer System..., Change Control, Regulatory Audits, Quality Auditing, Pharmaceutical Industry, Design Control, Pharmaceutics, Medical Devices, GAMP, Manufacturing, Cleaning Validation, Trackwise, Quality Assurance, FDA GMP, Software Documentation, Analytical Chemistry, Document Management, Chemistry, Laboratory, Biopharmaceuticals, Aseptic Processing, Technology Transfer, Auditing, Process Simulation, Root Cause Analysis, ISO, GLP, LIMS, Continuous Improvement, Regulatory Submissions, Deviations, SOP development, HPLC, ISO 14971, Quality Management, GCP, Formulation, Biotechnology, Internal Audit
Education
Universidad del Sagrado Corazón 1990 — 1997
Bachelor's degree, Chemistry
Validant February 2015 - April 2015
Puerto Rico Department of Health October 2014 - March 2015
Oxford International January 2015 - January 2015
LabChemS Corp December 2014 - December 2014
Puerto Rico Small Business Development Center January 2013 - August 2014
Stryker September 2013 - December 2013
Becton Dickinson January 2012 - October 2012
Novartis Consumer Health September 2010 - January 2012
Warner Chilcott February 2002 - October 2010
Wyeth 2001 - 2001
Skills
FDA, CAPA, GMP, Validation, Sop, Quality System, Quality Control, Regulatory Requirements, 21 CFR Part 11, ISO 13485, GxP, Computer System..., Change Control, Regulatory Audits, Quality Auditing, Pharmaceutical Industry, Design Control, Pharmaceutics, Medical Devices, GAMP, Manufacturing, Cleaning Validation, Trackwise, Quality Assurance, FDA GMP, Software Documentation, Analytical Chemistry, Document Management, Chemistry, Laboratory, Biopharmaceuticals, Aseptic Processing, Technology Transfer, Auditing, Process Simulation, Root Cause Analysis, ISO, GLP, LIMS, Continuous Improvement, Regulatory Submissions, Deviations, SOP development, HPLC, ISO 14971, Quality Management, GCP, Formulation, Biotechnology, Internal Audit
Education
Universidad del Sagrado Corazón 1990 — 1997
Bachelor's degree, Chemistry
Rebecca Venus, CQA's Validant Experience June 2010 - August 2010
Job Compliance and Quality Auditor and Consultant
Industry Pharmaceuticals
Experience
IHL Consulting Group, Inc. October 2011 - Present
Quintiles February 2011 - Present
Venus Consulting, LLC (Self-Employed) August 2007 - Present
Validant June 2010 - August 2010
Apotex Inc. June 2010 - August 2010
Boston Scientific August 2009 - June 2010
Boston Scientific August 2009 - June 2010
Pharmatech Associates, Inc. August 2007 - August 2009
Boston Scientific August 2007 - August 2009
Banner Pharmacaps October 2006 - August 2007
Skills
Quality Systems, CAPA, ISO 14971, ISO 13485, QSR, CQA, Management Review, Product Validation, ESD, DMR, PMA, USP, pH meter, MSDS, Centrifugation, Distillation, Column Chromatography, TLC, Titration, Wet Chemistry, Gas Chromatography, General Chemistry, Laboratory Techniques, Physical Chemistry, FDA, GMP, Sop, LIMS, Regulatory Affairs, Pharmaceutical Industry, Medical Devices, Quality Auditing, Quality Assurance, Cleaning Validation, HPLC, UV/Vis, GxP, Analytical Chemistry, Quality Control, R&D, Trackwise, Root Cause Analysis, Design Control, Manufacturing, Chromatography, Document Management, Chemistry, FTIR, Pharmaceutical...
Education
University of New Orleans 1989 — 1999
Bachelor of Science, Chemistry
Mount Carmel Academy 1985 — 1989
High School Diploma, General
IHL Consulting Group, Inc. October 2011 - Present
Quintiles February 2011 - Present
Venus Consulting, LLC (Self-Employed) August 2007 - Present
Validant June 2010 - August 2010
Apotex Inc. June 2010 - August 2010
Boston Scientific August 2009 - June 2010
Boston Scientific August 2009 - June 2010
Pharmatech Associates, Inc. August 2007 - August 2009
Boston Scientific August 2007 - August 2009
Banner Pharmacaps October 2006 - August 2007
Skills
Quality Systems, CAPA, ISO 14971, ISO 13485, QSR, CQA, Management Review, Product Validation, ESD, DMR, PMA, USP, pH meter, MSDS, Centrifugation, Distillation, Column Chromatography, TLC, Titration, Wet Chemistry, Gas Chromatography, General Chemistry, Laboratory Techniques, Physical Chemistry, FDA, GMP, Sop, LIMS, Regulatory Affairs, Pharmaceutical Industry, Medical Devices, Quality Auditing, Quality Assurance, Cleaning Validation, HPLC, UV/Vis, GxP, Analytical Chemistry, Quality Control, R&D, Trackwise, Root Cause Analysis, Design Control, Manufacturing, Chromatography, Document Management, Chemistry, FTIR, Pharmaceutical...
Education
University of New Orleans 1989 — 1999
Bachelor of Science, Chemistry
Mount Carmel Academy 1985 — 1989
High School Diploma, General
Helm Siegel's Validant Experience June 2005 - Present
Job
Industry Management Consulting
Experience
Validant June 2005 - Present
Harvey Nash August 2000 - June 2005
Skills
Portuguese, Risk Management, cGMP, International Project..., FDA, Pharmaceuticals, Biotechnology, Manufacturing, Technical Recruiting, Management, Recruiting, Medical Devices, Pharmaceutical Industry, Program Management, Executive Search, Business Development, CAPA, Cross-functional Team..., GMP, V
Education
University of Colorado at Boulder
BA
Telluride High School
Validant June 2005 - Present
Harvey Nash August 2000 - June 2005
Skills
Portuguese, Risk Management, cGMP, International Project..., FDA, Pharmaceuticals, Biotechnology, Manufacturing, Technical Recruiting, Management, Recruiting, Medical Devices, Pharmaceutical Industry, Program Management, Executive Search, Business Development, CAPA, Cross-functional Team..., GMP, V
Education
University of Colorado at Boulder
BA
Telluride High School
Robert Zagmot's Validant Experience June 2013 - Present
Job Medical Device and Pharmaceutical Quality Consultant
Industry Medical Devices
Experience
Validant June 2013 - Present
Stevens Institute of Technology January 2014 - Present
Maetrics, LLC April 2013 - May 2013
CR Bard July 2009 - February 2012
Roche January 2004 - June 2009
Zagmot Consulting January 2003 - January 2004
Anadigics January 2001 - January 2003
Price Pfister Faucets of Black & Decker (currently Pfister Faucets) January 2000 - January 2001
Seagate Technology August 1998 - January 2000
Rodel, Inc. (later bought by Rohm and Haas) August 1995 - August 1998
Skills
FDA, Quality Assurance, CAPA, Continuous Improvement, Quality System, Validation, ISO 13485, GMP, Design Control, Medical Devices, Quality Auditing, Quality Management, Six Sigma, 21 CFR Part 11, Root Cause Analysis, Quality Control, Change Control, Computer System..., V&V, Lean Manufacturing, Cross-functional Team..., Black Belt, Manufacturing, Design of Experiments, FMEA, SPC, Operational Excellence, DMAIC, Process Simulation, Sop, Minitab, ISO, Testing, Product Development, Value Stream Mapping, Green Belt, Kaizen, Statistical Data...
Education
Regis University 2002 — 2004
MBA, Business Administration and Management, General
University of Delaware 1991 — 1995
BS, Mechnical Engineering
Validant June 2013 - Present
Stevens Institute of Technology January 2014 - Present
Maetrics, LLC April 2013 - May 2013
CR Bard July 2009 - February 2012
Roche January 2004 - June 2009
Zagmot Consulting January 2003 - January 2004
Anadigics January 2001 - January 2003
Price Pfister Faucets of Black & Decker (currently Pfister Faucets) January 2000 - January 2001
Seagate Technology August 1998 - January 2000
Rodel, Inc. (later bought by Rohm and Haas) August 1995 - August 1998
Skills
FDA, Quality Assurance, CAPA, Continuous Improvement, Quality System, Validation, ISO 13485, GMP, Design Control, Medical Devices, Quality Auditing, Quality Management, Six Sigma, 21 CFR Part 11, Root Cause Analysis, Quality Control, Change Control, Computer System..., V&V, Lean Manufacturing, Cross-functional Team..., Black Belt, Manufacturing, Design of Experiments, FMEA, SPC, Operational Excellence, DMAIC, Process Simulation, Sop, Minitab, ISO, Testing, Product Development, Value Stream Mapping, Green Belt, Kaizen, Statistical Data...
Education
Regis University 2002 — 2004
MBA, Business Administration and Management, General
University of Delaware 1991 — 1995
BS, Mechnical Engineering
Dan Uno's Validant Experience April 2014 - Present
Job
Industry Medical Devices
Experience
Validant April 2014 - Present
Skills
Supplier Quality, Medical Devices, Quality Systems, Semiconductor Process, Printed Circuit Board..., Instrumentation, Quality Auditing, Process Engineering, Japanese, International, Internal Audit, Biotechnology Industry, Regulatory Affairs, Quality System, Validation, FDA, CAPA, ISO 13485, Quality Assurance, Testing, Product Development, Process Improvement, Continuous Improvement, Design for Manufacturing, Quality Control, Electronics, Injection Molding, Semiconductors, Minitab, Manufacturing Operations
Education
MS, Instrumentation Physics
University of California, Santa Barbara
BA, Biochemiistry
Validant April 2014 - Present
Skills
Supplier Quality, Medical Devices, Quality Systems, Semiconductor Process, Printed Circuit Board..., Instrumentation, Quality Auditing, Process Engineering, Japanese, International, Internal Audit, Biotechnology Industry, Regulatory Affairs, Quality System, Validation, FDA, CAPA, ISO 13485, Quality Assurance, Testing, Product Development, Process Improvement, Continuous Improvement, Design for Manufacturing, Quality Control, Electronics, Injection Molding, Semiconductors, Minitab, Manufacturing Operations
Education
MS, Instrumentation Physics
University of California, Santa Barbara
BA, Biochemiistry
Peter Joyce's Validant Experience July 2013 - Present
Job Senior Validation Consultant at Validant
Industry Biotechnology
Experience
Validant July 2013 - Present
Solexant August 2010 - July 2013
Complete Genomics September 2008 - August 2010
Microchip Biotechnologies August 2007 - January 2008
Affymetrix 2002 - 2007
Affymetrix 1999 - 2002
National Semiconductor 1997 - 1998
National Semiconductor 1994 - 1997
Advanced Visual Communications 1992 - 1994
ImageSet Design 1986 - 1994
Skills
Design of Experiments, SPC, R&D, Lean Manufacturing, Six Sigma, Quality System, Process Engineering, Manufacturing, GMP, Cross-functional Team..., ISO 13485, FDA, Manufacturing..., Continuous Improvement, Semiconductors, Validation, Project Planning, 5S, Process Simulation, Project Management, Product Development, Engineering Management, Manufacturing..., CAPA, 21 CFR Part 11, Engineering, Technology Transfer, Quality Management, Biotechnology, Medical Devices, Root Cause Analysis, FMEA, V&V, Design Control, Change Control, Quality Assurance, Process Improvement, Lifesciences, Design for Manufacturing, Kanban, Operational Excellence, Materials Management, 8D Problem Solving, Program Management, New Product Validation, Design for..., ISO 9001, High Performance..., New Product..., Life Sciences
Education
University of Maine
Bachelor of Science (BS), Electrical Engineering
University of Maine
Bachelor of Science (BS), Mechanical Engineering
Validant July 2013 - Present
Solexant August 2010 - July 2013
Complete Genomics September 2008 - August 2010
Microchip Biotechnologies August 2007 - January 2008
Affymetrix 2002 - 2007
Affymetrix 1999 - 2002
National Semiconductor 1997 - 1998
National Semiconductor 1994 - 1997
Advanced Visual Communications 1992 - 1994
ImageSet Design 1986 - 1994
Skills
Design of Experiments, SPC, R&D, Lean Manufacturing, Six Sigma, Quality System, Process Engineering, Manufacturing, GMP, Cross-functional Team..., ISO 13485, FDA, Manufacturing..., Continuous Improvement, Semiconductors, Validation, Project Planning, 5S, Process Simulation, Project Management, Product Development, Engineering Management, Manufacturing..., CAPA, 21 CFR Part 11, Engineering, Technology Transfer, Quality Management, Biotechnology, Medical Devices, Root Cause Analysis, FMEA, V&V, Design Control, Change Control, Quality Assurance, Process Improvement, Lifesciences, Design for Manufacturing, Kanban, Operational Excellence, Materials Management, 8D Problem Solving, Program Management, New Product Validation, Design for..., ISO 9001, High Performance..., New Product..., Life Sciences
Education
University of Maine
Bachelor of Science (BS), Electrical Engineering
University of Maine
Bachelor of Science (BS), Mechanical Engineering
Lou Angelucci's Validant Experience 2012 - January 2014
Job Senior Consultant at ALKU Consulting
Industry Pharmaceuticals
Experience
ALKU Consulting January 2015 - Present
Validant 2012 - January 2014
Quantic 2011 - 2012
MedImmune LLC January 2009 - September 2011
Inverness Medical June 2007 - January 2009
Bristol-Myers Squibb, Princeton, New Jersey January 2005 - June 2007
Aker Kvaerner Pharmaceuticals January 2003 - January 2005
Foster Wheeler January 1997 - January 2003
Prior Experience to 1997 January 1990 - January 1997
Skills
Validation, FDA, GMP, Quality System, CAPA, Change Control, 21 CFR Part 11, Quality Assurance, V&V, GxP, Biopharmaceuticals, Sop, GAMP, Biotechnology, Technology Transfer, Pharmaceutical Industry, Computer System..., Process Improvement, Regulatory Requirements, Regulatory Affairs, Process Simulation, Medical Devices, Lifesciences, Quality Auditing, Consent Decree, Risk Management, Enterprise Risk..., CGMP Compliance, PPQ and CPV, OSD, Vaccines, Aseptic Processing, C&Q, facility Engineering, Validation Master Plans, Compliance training, Certified Software..., Certified Quality..., DEA experience, MHRA and EU, ANDA, 510K and PMA submissions, Project Management, Blood Fractionation, Regulatory Audits and..., Adjunct professor, Published Author, Frequent speaker, Quality Control, Regulatory Submissions
Education
Drexel University 1991 — 1994
Master's Degree in Engineering Management, Engineering/Industrial Management
University of Pennsylvania 1977 — 1980
Master's Degree in Engineering, Biomedical Engineering
Ursinus College 1973 — 1977
B.S., Bio major Chem minor
ALKU Consulting January 2015 - Present
Validant 2012 - January 2014
Quantic 2011 - 2012
MedImmune LLC January 2009 - September 2011
Inverness Medical June 2007 - January 2009
Bristol-Myers Squibb, Princeton, New Jersey January 2005 - June 2007
Aker Kvaerner Pharmaceuticals January 2003 - January 2005
Foster Wheeler January 1997 - January 2003
Prior Experience to 1997 January 1990 - January 1997
Skills
Validation, FDA, GMP, Quality System, CAPA, Change Control, 21 CFR Part 11, Quality Assurance, V&V, GxP, Biopharmaceuticals, Sop, GAMP, Biotechnology, Technology Transfer, Pharmaceutical Industry, Computer System..., Process Improvement, Regulatory Requirements, Regulatory Affairs, Process Simulation, Medical Devices, Lifesciences, Quality Auditing, Consent Decree, Risk Management, Enterprise Risk..., CGMP Compliance, PPQ and CPV, OSD, Vaccines, Aseptic Processing, C&Q, facility Engineering, Validation Master Plans, Compliance training, Certified Software..., Certified Quality..., DEA experience, MHRA and EU, ANDA, 510K and PMA submissions, Project Management, Blood Fractionation, Regulatory Audits and..., Adjunct professor, Published Author, Frequent speaker, Quality Control, Regulatory Submissions
Education
Drexel University 1991 — 1994
Master's Degree in Engineering Management, Engineering/Industrial Management
University of Pennsylvania 1977 — 1980
Master's Degree in Engineering, Biomedical Engineering
Ursinus College 1973 — 1977
B.S., Bio major Chem minor
Scott Shepard's Validant Experience March 2015 - Present
Job Consultant at Validant
Industry Pharmaceuticals
Experience
Validant March 2015 - Present
Validant February 2013 - February 2015
ISTA Pharmaceuticals November 2007 - July 2012
Watson Pharmaceuticals September 2002 - November 2007
Wyeth August 1998 - September 2002
IES September 1997 - June 1998
ICI September 1994 - September 1997
University of Michigan 1992 - 1993
DuPont Merck Pharmaceuticals 1988 - 1993
Skills
Microbiology, CAPA, Change Control, Validation, ISOtrain, SOP development, Strategic Sourcing, Portfolio Management, Compliance, Supervision, Internal Audit, Contract Negotiation, Supplier Negotiation, Quality Auditing, Investigation, Sterilization, Powder, Powder Coating, Solid Oral Dosage Forms, Liquids, Nasal, Opthalmic, SAP, Trackwise, ISO, FDA GMP, FDA, Cold Chain, Transportation, Supply Chain, Supply Chain Management, Metrics Reporting, Performance Metrics, Contract Manufacturing, Lean Manufacturing, Quality Management, Manufacturing, Manufacturing..., Protocol, Equipment Qualification, Process Qualification, New Product..., Distribution Center..., API, Sales, Sales Management, Consent Decree, Metrics, Auditing, Quality Assurance
Education
University of Michigan 1992 — 1993
MS, Industrial Engineering
University of Delaware 1988 — 1992
BS, Chemical Engineering
Validant March 2015 - Present
Validant February 2013 - February 2015
ISTA Pharmaceuticals November 2007 - July 2012
Watson Pharmaceuticals September 2002 - November 2007
Wyeth August 1998 - September 2002
IES September 1997 - June 1998
ICI September 1994 - September 1997
University of Michigan 1992 - 1993
DuPont Merck Pharmaceuticals 1988 - 1993
Skills
Microbiology, CAPA, Change Control, Validation, ISOtrain, SOP development, Strategic Sourcing, Portfolio Management, Compliance, Supervision, Internal Audit, Contract Negotiation, Supplier Negotiation, Quality Auditing, Investigation, Sterilization, Powder, Powder Coating, Solid Oral Dosage Forms, Liquids, Nasal, Opthalmic, SAP, Trackwise, ISO, FDA GMP, FDA, Cold Chain, Transportation, Supply Chain, Supply Chain Management, Metrics Reporting, Performance Metrics, Contract Manufacturing, Lean Manufacturing, Quality Management, Manufacturing, Manufacturing..., Protocol, Equipment Qualification, Process Qualification, New Product..., Distribution Center..., API, Sales, Sales Management, Consent Decree, Metrics, Auditing, Quality Assurance
Education
University of Michigan 1992 — 1993
MS, Industrial Engineering
University of Delaware 1988 — 1992
BS, Chemical Engineering
Tony Marzuco's Validant Experience June 2010 - September 2010
Job Quality Systems Manager at McNeil Consumer Healthcare
Industry Pharmaceuticals
Experience
McNeil Consumer Healthcare April 2011 - Present
Validant June 2010 - September 2010
KV Pharmaceutical September 2008 - June 2010
Express Scripts December 2004 - September 2008
Covidien 2004 - 2004
Wyeth 2002 - 2004
Genentech 1998 - 2002
Celtix Pharmaceuticals 1996 - 1998
Skills
Change Control, CAPA, FDA, Validation, Quality System, Regulatory Requirements, Quality Auditing, Quality Assurance, GMP, ISO 13485, Root Cause Analysis, Pharmaceutics, Six Sigma, GxP, Trackwise, 21 CFR Part 11, Auditing, Aseptic Processing, TrackWise
Education
University of Missouri-Saint Louis
BS, Biology
McNeil Consumer Healthcare April 2011 - Present
Validant June 2010 - September 2010
KV Pharmaceutical September 2008 - June 2010
Express Scripts December 2004 - September 2008
Covidien 2004 - 2004
Wyeth 2002 - 2004
Genentech 1998 - 2002
Celtix Pharmaceuticals 1996 - 1998
Skills
Change Control, CAPA, FDA, Validation, Quality System, Regulatory Requirements, Quality Auditing, Quality Assurance, GMP, ISO 13485, Root Cause Analysis, Pharmaceutics, Six Sigma, GxP, Trackwise, 21 CFR Part 11, Auditing, Aseptic Processing, TrackWise
Education
University of Missouri-Saint Louis
BS, Biology
Nakia Edwards's Validant Experience August 2014 - Present
Job Compliance Consultant for Medical Device/Pharmaceutical Companies
Industry Pharmaceuticals
Experience
Validant August 2014 - Present
MAETRICS March 2013 - August 2014
Alcon Laboratories, Inc. June 2012 - March 2013
AmPharmCo., Inc. January 2006 - June 2012
Skills
Process Improvement, Software Documentation, Testing, Quality Assurance, Quality System, Validation, Medical Devices, Sop, GMP, Quality Control, Training, Microsoft Office, Pharmaceutical Industry, FDA, 21 CFR Part 11, Leadership
Education
University of Louisiana at Monroe 1992 — 2000
Huntington High School
Validant August 2014 - Present
MAETRICS March 2013 - August 2014
Alcon Laboratories, Inc. June 2012 - March 2013
AmPharmCo., Inc. January 2006 - June 2012
Skills
Process Improvement, Software Documentation, Testing, Quality Assurance, Quality System, Validation, Medical Devices, Sop, GMP, Quality Control, Training, Microsoft Office, Pharmaceutical Industry, FDA, 21 CFR Part 11, Leadership
Education
University of Louisiana at Monroe 1992 — 2000
Huntington High School
Rick Frame's Validant Experience 2013 - 2014
Job Senior Process and Formulation Development Chemist, CLSSBB
Industry Medical Devices
Experience
Alere, Inc. 2014 - Present
Validant 2013 - 2014
Arkal Medical 2008 - 2011
ALZA Corporation September 1992 - October 2007
Skills
Medical Devices, Drug Delivery, Chemistry, Formulation, Validation, R&D, Design of Experiments, HPLC, Biotechnology, Technology Transfer, Assay Development, Pharmaceutical Industry, GMP, Biosensors
Education
University of California, Berkeley
Bachelor of Science (BS)
Alere, Inc. 2014 - Present
Validant 2013 - 2014
Arkal Medical 2008 - 2011
ALZA Corporation September 1992 - October 2007
Skills
Medical Devices, Drug Delivery, Chemistry, Formulation, Validation, R&D, Design of Experiments, HPLC, Biotechnology, Technology Transfer, Assay Development, Pharmaceutical Industry, GMP, Biosensors
Education
University of California, Berkeley
Bachelor of Science (BS)
Dan Dye's Validant Experience February 2012 - September 2012
Job Founder at Daniel Dye Consulting
Industry Pharmaceuticals
Experience
Daniel Dye Consulting May 2008 - Present
Validant February 2012 - September 2012
Dendreon, Manager Laboratory Services October 2010 - September 2011
Celator Pharmacetucals Corporation May 2007 - April 2008
Conor Medsystems 2005 - 2006
DepoMed, Inc 1998 - 2005
Scios, Inc. 1996 - 1997
ALZA Corporation 1979 - 1996
Skills
GMP, Validation, FDA, Quality System, Pharmaceutical Industry, Technology Transfer, Clinical Trials, Quality Assurance, Medical Devices, Clinical Development, Biotechnology, Drug Development, Regulatory Affairs, Lifesciences, Chromatography, HPLC, GLP, Life Sciences
Education
University of California, Davis 1971 — 1974
Master's degree, Biochemistry
San Jose State University 1965 — 1969
Bachelor's degree, Chemistry
Daniel Dye Consulting May 2008 - Present
Validant February 2012 - September 2012
Dendreon, Manager Laboratory Services October 2010 - September 2011
Celator Pharmacetucals Corporation May 2007 - April 2008
Conor Medsystems 2005 - 2006
DepoMed, Inc 1998 - 2005
Scios, Inc. 1996 - 1997
ALZA Corporation 1979 - 1996
Skills
GMP, Validation, FDA, Quality System, Pharmaceutical Industry, Technology Transfer, Clinical Trials, Quality Assurance, Medical Devices, Clinical Development, Biotechnology, Drug Development, Regulatory Affairs, Lifesciences, Chromatography, HPLC, GLP, Life Sciences
Education
University of California, Davis 1971 — 1974
Master's degree, Biochemistry
San Jose State University 1965 — 1969
Bachelor's degree, Chemistry
Jorge Aday's Validant Experience 2012 - Present
Job consultant at Validant
Industry Medical Devices
Experience
Validant 2012 - Present
Operations Engineering Solutions LLC September 2011 - September 2012
medinstill June 2006 - July 2011
ConMed Linvatec 1995 - 2006
Skills
Validation, CAPA, Root Cause Analysis, Manufacturing, Pharmaceutical Industry, Continuous Improvement, Quality Control, Technology Transfer, Sop, Quality Auditing, Engineering, GMP, V&V, R&D, Computer System..., Change Control, GxP, 21 CFR Part 11, Quality Assurance, Biopharmaceuticals, Biotechnology, GAMP, Design Control, ISO, Regulatory Requirements, Aseptic Processing, DMAIC, Product Launch, ISO 14971, Technical Writing, FDA GMP, Biomedical Engineering, Packaging, FDA, Medical Devices
Education
Stevens Institute of Technology
Validant 2012 - Present
Operations Engineering Solutions LLC September 2011 - September 2012
medinstill June 2006 - July 2011
ConMed Linvatec 1995 - 2006
Skills
Validation, CAPA, Root Cause Analysis, Manufacturing, Pharmaceutical Industry, Continuous Improvement, Quality Control, Technology Transfer, Sop, Quality Auditing, Engineering, GMP, V&V, R&D, Computer System..., Change Control, GxP, 21 CFR Part 11, Quality Assurance, Biopharmaceuticals, Biotechnology, GAMP, Design Control, ISO, Regulatory Requirements, Aseptic Processing, DMAIC, Product Launch, ISO 14971, Technical Writing, FDA GMP, Biomedical Engineering, Packaging, FDA, Medical Devices
Education
Stevens Institute of Technology
John Radzyminski's Validant Experience May 2012 - October 2012
Job Quality Assurance Consultant at Gilead Sciences
Industry Biotechnology
Experience
Gilead Sciences April 2014 - Present
Bayer HealthCare October 2012 - September 2013
Validant May 2012 - October 2012
Agile Pharmacy Services December 2011 - May 2012
Genentech January 2010 - December 2011
Genentech April 2008 - January 2010
Scios Inc. 2003 - 2007
Johnson and Johnson 2003 - 2007
FibroGen Inc. 2001 - 2003
Calydon 1999 - 2001
Skills
cGMP, Root Cause Analysis, Risk Analysis, Internal Audit, Fermentation, Pilot Plant, Lyophilization, Aseptic Processing, Documentation, SAP R/3, Contract Manufacturing, International Supply..., Cell Culture, Quality Assurance, GMP
Education
University of California, Los Angeles - The Anderson School of Management 1996 — 1999
Master of Business Administration, Operations and Strategy
University of California, Davis 1982 — 1986
B.S., Fermentation Sciences
Westlake High School 1978 — 1981
Gilead Sciences April 2014 - Present
Bayer HealthCare October 2012 - September 2013
Validant May 2012 - October 2012
Agile Pharmacy Services December 2011 - May 2012
Genentech January 2010 - December 2011
Genentech April 2008 - January 2010
Scios Inc. 2003 - 2007
Johnson and Johnson 2003 - 2007
FibroGen Inc. 2001 - 2003
Calydon 1999 - 2001
Skills
cGMP, Root Cause Analysis, Risk Analysis, Internal Audit, Fermentation, Pilot Plant, Lyophilization, Aseptic Processing, Documentation, SAP R/3, Contract Manufacturing, International Supply..., Cell Culture, Quality Assurance, GMP
Education
University of California, Los Angeles - The Anderson School of Management 1996 — 1999
Master of Business Administration, Operations and Strategy
University of California, Davis 1982 — 1986
B.S., Fermentation Sciences
Westlake High School 1978 — 1981
Minh-Tram Nguyen's Validant Experience March 2014 - Present
Job Consultant / Data Reviewer at Validant
Industry Pharmaceuticals
Experience
Validant March 2014 - Present
ProUnlimited July 2013 - March 2014
Aerotek September 2011 - July 2013
US Tech Solutions September 2010 - September 2011
Depomed, Inc. 2007 - 2009
ALZA Corp. / Johnson & Johnson 1997 - 2007
Skills
HPLC, Validation, cGMP, GMP, Pharmaceuticals, Chemistry, Compliance, Biotechnology, SOP, Medical Devices, R&D, Analytical Chemistry, Chromatography, Research, Process Validation, PowerPoint, CAPA, Pharmaceutical Industry
Education
San Francisco State University
BS
Validant March 2014 - Present
ProUnlimited July 2013 - March 2014
Aerotek September 2011 - July 2013
US Tech Solutions September 2010 - September 2011
Depomed, Inc. 2007 - 2009
ALZA Corp. / Johnson & Johnson 1997 - 2007
Skills
HPLC, Validation, cGMP, GMP, Pharmaceuticals, Chemistry, Compliance, Biotechnology, SOP, Medical Devices, R&D, Analytical Chemistry, Chromatography, Research, Process Validation, PowerPoint, CAPA, Pharmaceutical Industry
Education
San Francisco State University
BS
Carl Hoffman's Validant Experience July 2011 - December 2011
Job Director, Quality Control at Fujifilm Diosynth Biotechnologies Texas (Formerly Kalon)
Industry Pharmaceuticals
Experience
FujiFilm Diosynth Biotechnologies Texas (FDBT) - (Formerly Kalon Biotherapeutics, LLC) January 2012 - Present
Validant July 2011 - December 2011
Cook Pharmica June 2010 - April 2011
PharmaForm LLC November 2008 - September 2009
Novartis Corporation (Formerly Chiron) August 1990 - November 2008
Education
University of California, Santa Barbara
BA
FujiFilm Diosynth Biotechnologies Texas (FDBT) - (Formerly Kalon Biotherapeutics, LLC) January 2012 - Present
Validant July 2011 - December 2011
Cook Pharmica June 2010 - April 2011
PharmaForm LLC November 2008 - September 2009
Novartis Corporation (Formerly Chiron) August 1990 - November 2008
Education
University of California, Santa Barbara
BA
Brian Brutcher's Validant Experience April 2012 - May 2013
Job Insurance Sales Agent at Bankers Life
Industry Medical Devices
Experience
Bankers Life February 2015 - Present
Natharon Lifesciences Consulting LLC April 2012 - Present
Validant April 2012 - May 2013
Self Employeed January 2011 - September 2012
Edwards Lifesciences January 1998 - May 2011
Edwards Lifesciences 1981 - 2008
Pepperdine May 2002 - May 2004
Skills
Start-ups, Biomedical Engineering, Medical Devices, Manufacturing, Design Control, V&V, Lean Manufacturing, Lifesciences, Validation, CAPA, Management, Quality System, Cross-functional Team..., FDA, Design of Experiments, ISO 13485, Commercialization, R&D, GMP, Engineering, Minitab, Product Launch, Strategy, Product Development, Six Sigma, Process Simulation, FMEA, Quality Assurance, ISO, Root Cause Analysis, DMAIC, Regulatory Affairs
Education
Pepperdine University, The George L. Graziadio School of Business and Management 2002 — 2004
MBA, MBA Finance Emphasis
University of Illinois at Urbana-Champaign 1976 — 1981
Engineering, General Engineering (Mechanical-Bioengineering)
Bankers Life February 2015 - Present
Natharon Lifesciences Consulting LLC April 2012 - Present
Validant April 2012 - May 2013
Self Employeed January 2011 - September 2012
Edwards Lifesciences January 1998 - May 2011
Edwards Lifesciences 1981 - 2008
Pepperdine May 2002 - May 2004
Skills
Start-ups, Biomedical Engineering, Medical Devices, Manufacturing, Design Control, V&V, Lean Manufacturing, Lifesciences, Validation, CAPA, Management, Quality System, Cross-functional Team..., FDA, Design of Experiments, ISO 13485, Commercialization, R&D, GMP, Engineering, Minitab, Product Launch, Strategy, Product Development, Six Sigma, Process Simulation, FMEA, Quality Assurance, ISO, Root Cause Analysis, DMAIC, Regulatory Affairs
Education
Pepperdine University, The George L. Graziadio School of Business and Management 2002 — 2004
MBA, MBA Finance Emphasis
University of Illinois at Urbana-Champaign 1976 — 1981
Engineering, General Engineering (Mechanical-Bioengineering)
Stephen Pyle, Ph.D's Validant Experience September 2013 - Present
Job Production & Process Control SME at Validant
Industry Medical Devices
Experience
Validant September 2013 - Present
Validant September 2013 - June 2014
Merz Aesthetics Inc. June 2012 - March 2013
Abbott Diagnostics September 2008 - July 2012
Abbott Diagnostics September 2007 - August 2008
Abbott Diagnostics January 2003 - September 2007
Abbott Diagnostics December 1999 - December 2002
Abbott Diagnostics June 1996 - December 1999
Abbott Diagnostics May 1990 - May 1996
Program Resources Inc. February 1986 - May 1990
Education
The University of Georgia 1980 — 1983
Ph.D.
The University of Georgia 1977 — 1980
M.S.
University of Maryland College Park 1974 — 1976
B.S.
Purdue University 1972 — 1974
Validant September 2013 - Present
Validant September 2013 - June 2014
Merz Aesthetics Inc. June 2012 - March 2013
Abbott Diagnostics September 2008 - July 2012
Abbott Diagnostics September 2007 - August 2008
Abbott Diagnostics January 2003 - September 2007
Abbott Diagnostics December 1999 - December 2002
Abbott Diagnostics June 1996 - December 1999
Abbott Diagnostics May 1990 - May 1996
Program Resources Inc. February 1986 - May 1990
Education
The University of Georgia 1980 — 1983
Ph.D.
The University of Georgia 1977 — 1980
M.S.
University of Maryland College Park 1974 — 1976
B.S.
Purdue University 1972 — 1974
Sudha Thakur's Validant Experience January 2012 - December 2014
Job Data Review Specialist at Gilead Sciences
Industry Pharmaceuticals
Experience
Gilead Sciences March 2015 - Present
Validant January 2012 - December 2014
Abbott Vascular July 2009 - August 2011
Conor Medsystems October 2008 - December 2008
Conor Medsystems January 2003 - October 2008
Quanam Medical corporation (Boston Scientific) 1997 - 2002
Skills
Karl Fisher, HPLC, Gas Chromatography, Chromatography, FTIR, Method Development, Validation, Polymers, FDA, Analytical Chemistry, GLP, Formulation, Quality Control, Drug Delivery, Medical Devices, Differential Scanning...
Education
Patna University 1982 — 1989
MS in Biology, India
Gilead Sciences March 2015 - Present
Validant January 2012 - December 2014
Abbott Vascular July 2009 - August 2011
Conor Medsystems October 2008 - December 2008
Conor Medsystems January 2003 - October 2008
Quanam Medical corporation (Boston Scientific) 1997 - 2002
Skills
Karl Fisher, HPLC, Gas Chromatography, Chromatography, FTIR, Method Development, Validation, Polymers, FDA, Analytical Chemistry, GLP, Formulation, Quality Control, Drug Delivery, Medical Devices, Differential Scanning...
Education
Patna University 1982 — 1989
MS in Biology, India
Mickey Chatman's Validant Experience January 2012 - May 2012
Job Assistant Controller at Ergo Contract Furniture
Industry Accounting
Experience
Ergo Contract Furniture April 2015 - Present
Proteus Digital Health, Inc August 2013 - March 2015
Engine-Room May 2013 - August 2013
N/A March 2010 - August 2013
Apttus December 2012 - April 2013
Validant January 2012 - May 2012
Chrome September 2011 - January 2012
Attune Foods May 2010 - July 2010
University Games March 2010 - May 2010
Tomatina International, Inc March 2008 - March 2010
Skills
Forensic Accounting, Reconciliations, Auditing, Full Cycle Accounting, Accounting, Invoicing, Expenses, Billing, Journal Entries, General Ledger, Reconciliation, Account Reconciliation, Accounts Payable, Accruals, Accounts Receivable, Fixed Assets, Quickbooks, GAAP, Financial Reporting, Bookkeeping, Financial Accounting, Statements, Variance Analysis, Balance, Sales Tax, Payroll, Cash Flow, Payroll Processing, Internal Controls, Cash, Cash Management, Financial Analysis, Bank Reconciliation, Budgets, Revenue Recognition, Year-end Close, Data Entry, Cost Accounting, Forecasting, Analysis, Customer Service, Microsoft Excel, Depreciation, Internal Audit, Preparation, Consolidation, US GAAP, Process Improvement, Payroll Taxes, Outlook
Education
San Francisco State University 2003 — 2006
Bachelor of Arts; work, Economics; finance; statistics, econometrics, quantitative applications
Ergo Contract Furniture April 2015 - Present
Proteus Digital Health, Inc August 2013 - March 2015
Engine-Room May 2013 - August 2013
N/A March 2010 - August 2013
Apttus December 2012 - April 2013
Validant January 2012 - May 2012
Chrome September 2011 - January 2012
Attune Foods May 2010 - July 2010
University Games March 2010 - May 2010
Tomatina International, Inc March 2008 - March 2010
Skills
Forensic Accounting, Reconciliations, Auditing, Full Cycle Accounting, Accounting, Invoicing, Expenses, Billing, Journal Entries, General Ledger, Reconciliation, Account Reconciliation, Accounts Payable, Accruals, Accounts Receivable, Fixed Assets, Quickbooks, GAAP, Financial Reporting, Bookkeeping, Financial Accounting, Statements, Variance Analysis, Balance, Sales Tax, Payroll, Cash Flow, Payroll Processing, Internal Controls, Cash, Cash Management, Financial Analysis, Bank Reconciliation, Budgets, Revenue Recognition, Year-end Close, Data Entry, Cost Accounting, Forecasting, Analysis, Customer Service, Microsoft Excel, Depreciation, Internal Audit, Preparation, Consolidation, US GAAP, Process Improvement, Payroll Taxes, Outlook
Education
San Francisco State University 2003 — 2006
Bachelor of Arts; work, Economics; finance; statistics, econometrics, quantitative applications
Donald Shannon's Validant Experience September 2012 - December 2012
Job Director, Process Engineering
Industry Medical Devices
Experience
LoneStar Heart November 2013 - Present
ASQ Section 0701 2007 - Present
ASQ Orange Empire Section # 0701 February 2008 - July 2014
Oxford Global Resources December 2012 - March 2013
Validant September 2012 - December 2012
Covidien / EV3 June 2011 - September 2012
Abbott AMO September 2010 - July 2011
DSC 2006 - September 2010
AYSO 1992 - 2010
ASQ 2008 - 2009
Skills
Medical Devices, Validation, Engineering, Packaging, FDA, CAPA, Design Control, Manufacturing, R&D, Process Engineering, Testing, ISO 13485, Quality System, GMP, Quality Assurance, Design of Experiments, Process Simulation, Quality Control, Lean Manufacturing, FMEA, Cross-functional Team..., Regulatory Affairs, Change Control, Root Cause Analysis, Quality Auditing, ISO 14971, SPC, Sop, Electronics, Software Documentation, Quality Management, Six Sigma, Product Design, Product Development, Supplier Quality, Manufacturing..., ISO, DMAIC, Continuous Improvement, Biomedical Engineering, Design for Manufacturing, Minitab, Injection Molding, Iso 9000, Kaizen, 5S, Value Stream Mapping, Engineering Management, TQM, Manufacturing...
Education
Northern Arizona University 1980 — 1985
Bachelor of Science (B.S.), Electrical and Electronics Engineering
CIHS
LoneStar Heart November 2013 - Present
ASQ Section 0701 2007 - Present
ASQ Orange Empire Section # 0701 February 2008 - July 2014
Oxford Global Resources December 2012 - March 2013
Validant September 2012 - December 2012
Covidien / EV3 June 2011 - September 2012
Abbott AMO September 2010 - July 2011
DSC 2006 - September 2010
AYSO 1992 - 2010
ASQ 2008 - 2009
Skills
Medical Devices, Validation, Engineering, Packaging, FDA, CAPA, Design Control, Manufacturing, R&D, Process Engineering, Testing, ISO 13485, Quality System, GMP, Quality Assurance, Design of Experiments, Process Simulation, Quality Control, Lean Manufacturing, FMEA, Cross-functional Team..., Regulatory Affairs, Change Control, Root Cause Analysis, Quality Auditing, ISO 14971, SPC, Sop, Electronics, Software Documentation, Quality Management, Six Sigma, Product Design, Product Development, Supplier Quality, Manufacturing..., ISO, DMAIC, Continuous Improvement, Biomedical Engineering, Design for Manufacturing, Minitab, Injection Molding, Iso 9000, Kaizen, 5S, Value Stream Mapping, Engineering Management, TQM, Manufacturing...
Education
Northern Arizona University 1980 — 1985
Bachelor of Science (B.S.), Electrical and Electronics Engineering
CIHS
Ramesh Maragh's Validant Experience January 2014 - Present
Job Technical Services Consultant
Industry Pharmaceuticals
Experience
Validant January 2014 - Present
ALPHAOMEGA GROUP 2015 - 2015
Hospira July 2013 - December 2013
sandoz July 2007 - July 2011
Andrx 2004 - 2007
Bacardi and Company September 1998 - February 2000
Skills
V&V, CAPA, Validation, GMP, Change Control, FDA, Sop, Technology Transfer, Cleaning Validation, 21 CFR Part 11, Aseptic Processing, Quality System, GLP, GxP, Biopharmaceuticals, LIMS, Regulatory Affairs, Analysis, Quality Management, SOP
Education
Tuskegee University 1989 — 1995
Bachelor of Science (BS)
Validant January 2014 - Present
ALPHAOMEGA GROUP 2015 - 2015
Hospira July 2013 - December 2013
sandoz July 2007 - July 2011
Andrx 2004 - 2007
Bacardi and Company September 1998 - February 2000
Skills
V&V, CAPA, Validation, GMP, Change Control, FDA, Sop, Technology Transfer, Cleaning Validation, 21 CFR Part 11, Aseptic Processing, Quality System, GLP, GxP, Biopharmaceuticals, LIMS, Regulatory Affairs, Analysis, Quality Management, SOP
Education
Tuskegee University 1989 — 1995
Bachelor of Science (BS)
Jeff Shropshire's Validant Experience September 2011 - May 2012
Job Senior Consultant at PAREXEL
Industry Biotechnology
Experience
PAREXEL June 2013 - Present
Independent Consultant July 2012 - May 2013
Integra LifeSciences June 2011 - June 2012
Validant September 2011 - May 2012
Enzon Pharmaceuticals September 2008 - January 2009
Enzon Pharmaceuticals 2005 - 2008
Fresenius Medical Care 1996 - 2004
Education
Rutgers University-New Brunswick 1986 — 1988
BA, Microbiology
PAREXEL June 2013 - Present
Independent Consultant July 2012 - May 2013
Integra LifeSciences June 2011 - June 2012
Validant September 2011 - May 2012
Enzon Pharmaceuticals September 2008 - January 2009
Enzon Pharmaceuticals 2005 - 2008
Fresenius Medical Care 1996 - 2004
Education
Rutgers University-New Brunswick 1986 — 1988
BA, Microbiology
Beth Vela MS-ETM, CSSBB's Validant Experience April 2011 - September 2011
Job Senior Project Manager
Industry Medical Devices
Experience
Abbott Laboratories May 2013 - Present
Hospira January 2013 - May 2013
Kimberly-Clark October 2012 - January 2013
Baxter Healthcare 2011 - 2012
Validant April 2011 - September 2011
Abbott Laboratories February 2010 - January 2011
Abbott Laboratories July 1989 - March 2010
Abbott Laboratories 2000 - 2009
St. Therese Hospital September 1982 - July 1989
Skills
Six Sigma, Project Management, Quality Management, CAPA, FDA, GMP, Quality System, Validation, Design Control, Change Control, Medical Devices, V&V, 21 CFR Part 11, ISO 13485, Quality Assurance, Cross-functional Team..., GxP, Pharmaceutical Industry, GLP, Sop, Computer System..., Hardware Diagnostics, Laboratory, Quality Auditing, Quality Control
Education
Oklahoma State University 2009 — 2013
Masters of Science, Engineering and Technical Management
American Society of Quality 2010 — 2010
Certification, Six Sigma Black Belt
American Society of Quality 2008 — 2008
Certification, Manager of Quality and Organizational Excellence
University of Wisconsin 1978 — 1982
BACHELOR OF SCIENCE, Medical Technology
University of Wisconsin-Madison 1978 — 1982
BS, Medical Technology
Abbott Laboratories May 2013 - Present
Hospira January 2013 - May 2013
Kimberly-Clark October 2012 - January 2013
Baxter Healthcare 2011 - 2012
Validant April 2011 - September 2011
Abbott Laboratories February 2010 - January 2011
Abbott Laboratories July 1989 - March 2010
Abbott Laboratories 2000 - 2009
St. Therese Hospital September 1982 - July 1989
Skills
Six Sigma, Project Management, Quality Management, CAPA, FDA, GMP, Quality System, Validation, Design Control, Change Control, Medical Devices, V&V, 21 CFR Part 11, ISO 13485, Quality Assurance, Cross-functional Team..., GxP, Pharmaceutical Industry, GLP, Sop, Computer System..., Hardware Diagnostics, Laboratory, Quality Auditing, Quality Control
Education
Oklahoma State University 2009 — 2013
Masters of Science, Engineering and Technical Management
American Society of Quality 2010 — 2010
Certification, Six Sigma Black Belt
American Society of Quality 2008 — 2008
Certification, Manager of Quality and Organizational Excellence
University of Wisconsin 1978 — 1982
BACHELOR OF SCIENCE, Medical Technology
University of Wisconsin-Madison 1978 — 1982
BS, Medical Technology
Robert Mavar's Validant Experience June 2012 - July 2013
Job Associate Scientist at Gilead Sciences
Industry Pharmaceuticals
Experience
Gilead Sciences July 2013 - Present
Validant June 2012 - July 2013
Depomed October 2008 - April 2012
Affymax March 2007 - October 2008
Roche Palo Alto November 1996 - March 2007
SRI International August 1988 - November 1996
Skills
Pharmaceutical Industry, HPLC, Analytical Chemistry, Chromatography, GLP, IR, Sop, Laboratory, Differential Scanning..., Dissolution, GC-MS, Technology Transfer, Formulation, Analytical Techniques, NMR, UV/Vis, Gas Chromatography, Chemistry
Education
San Jose State University
MS, Chemistry
San Jose State University
BS, Chemistry
Gilead Sciences July 2013 - Present
Validant June 2012 - July 2013
Depomed October 2008 - April 2012
Affymax March 2007 - October 2008
Roche Palo Alto November 1996 - March 2007
SRI International August 1988 - November 1996
Skills
Pharmaceutical Industry, HPLC, Analytical Chemistry, Chromatography, GLP, IR, Sop, Laboratory, Differential Scanning..., Dissolution, GC-MS, Technology Transfer, Formulation, Analytical Techniques, NMR, UV/Vis, Gas Chromatography, Chemistry
Education
San Jose State University
MS, Chemistry
San Jose State University
BS, Chemistry
Pablo McConnie-Saad's Validant Experience August 2013 - May 2014
Job Public Administration Fellow at the University of Delaware
Industry Public Policy
Experience
Institute for Public Administration August 2015 - Present
Malabar Group DRC May 2014 - January 2015
Validant August 2013 - May 2014
As You Sow April 2013 - August 2013
CIEE Council on International Educational Exchange November 2010 - August 2012
Skills
Research, Higher Education, Public Speaking, Qualitative Research, International Relations, Grant Writing, Data Analysis, Policy Analysis, Community Outreach, Nonprofits, Business Development, Market Research, Analysis, Social Networking, Strategy, Editing
Education
University of Delaware 2015 — 2017
Master of Public Administration (MPA), Economic Development and Planning
Oberlin College 2006 — 2010
Bachelor of Arts (BA)
Germantown Friends School
Institute for Public Administration August 2015 - Present
Malabar Group DRC May 2014 - January 2015
Validant August 2013 - May 2014
As You Sow April 2013 - August 2013
CIEE Council on International Educational Exchange November 2010 - August 2012
Skills
Research, Higher Education, Public Speaking, Qualitative Research, International Relations, Grant Writing, Data Analysis, Policy Analysis, Community Outreach, Nonprofits, Business Development, Market Research, Analysis, Social Networking, Strategy, Editing
Education
University of Delaware 2015 — 2017
Master of Public Administration (MPA), Economic Development and Planning
Oberlin College 2006 — 2010
Bachelor of Arts (BA)
Germantown Friends School
Nyla Kennard's Validant Experience July 2013 - December 2013
Job CAPA Consultant with Validant Consulting
Industry Medical Devices
Experience
Baxter Healthcare September 2014 - December 2014
Fresenius Medical Care December 2013 - September 2014
Validant July 2013 - December 2013
Quest Medical June 2012 - July 2013
St. Jude Medical August 2011 - June 2012
Mentor / Ethicon August 2009 - July 2011
DESARA February 2009 - August 2009
Abbott Diagnostics June 2007 - November 2008
Abbott Diagnostics September 2003 - June 2007
Abbott Diagnostics September 2001 - September 2003
Skills
CAPA, CQE, Coaching, Cross-functional Team..., Customer Satisfaction, Design Control, FDA, ISO, ISO 13485, Leadership, Medical Devices, Quality Assurance, Quality Management, Quality System, Six Sigma
Education
University of Iowa 1978 — 1982
BS, General Science/Medical Technology
Baxter Healthcare September 2014 - December 2014
Fresenius Medical Care December 2013 - September 2014
Validant July 2013 - December 2013
Quest Medical June 2012 - July 2013
St. Jude Medical August 2011 - June 2012
Mentor / Ethicon August 2009 - July 2011
DESARA February 2009 - August 2009
Abbott Diagnostics June 2007 - November 2008
Abbott Diagnostics September 2003 - June 2007
Abbott Diagnostics September 2001 - September 2003
Skills
CAPA, CQE, Coaching, Cross-functional Team..., Customer Satisfaction, Design Control, FDA, ISO, ISO 13485, Leadership, Medical Devices, Quality Assurance, Quality Management, Quality System, Six Sigma
Education
University of Iowa 1978 — 1982
BS, General Science/Medical Technology
Jay Sherbine's Validant Experience January 2012 - Present
Job Quality SME and Project Manager at Validant
Industry Pharmaceuticals
Experience
Validant January 2012 - Present
JPS Consulting January 2009 - Present
Bristol-Myers Squibb 1996 - 2008
DuPont Pharmaceuticals 1996 - 2001
Rhone-Poulenc Rorer 1989 - 1996
Ash Stevens Inc. 1987 - 1989
Smithkline and French 1985 - 1987
Skills
Quality Risk Management, Process Validation, Project Portfolio..., cGMP practices, cGMP manufacturing, Cross-functional Team..., Technical Transfers, Equipment Qualification, Instrument Qualification, Technology Transfer, Pharmaceutical Industry, GMP, Drug Development, Chemistry, R&D, Quality System, Organic Chemistry, Validation, Sop, Analytical Chemistry, GLP, Quality Auditing, Manufacturing, FDA, GxP, Product Development, Regulatory Requirements, Quality Assurance, HPLC, Risk Management, Lean Manufacturing, Quality Control, Management, Project Management, Formulation, Process Improvement, Quality Management, Leadership
Education
University of Pittsburgh 1980 — 1985
PhD, Chemistry
The Johns Hopkins University 1976 — 1980
BA, Chemistry
mckeesport high
Validant January 2012 - Present
JPS Consulting January 2009 - Present
Bristol-Myers Squibb 1996 - 2008
DuPont Pharmaceuticals 1996 - 2001
Rhone-Poulenc Rorer 1989 - 1996
Ash Stevens Inc. 1987 - 1989
Smithkline and French 1985 - 1987
Skills
Quality Risk Management, Process Validation, Project Portfolio..., cGMP practices, cGMP manufacturing, Cross-functional Team..., Technical Transfers, Equipment Qualification, Instrument Qualification, Technology Transfer, Pharmaceutical Industry, GMP, Drug Development, Chemistry, R&D, Quality System, Organic Chemistry, Validation, Sop, Analytical Chemistry, GLP, Quality Auditing, Manufacturing, FDA, GxP, Product Development, Regulatory Requirements, Quality Assurance, HPLC, Risk Management, Lean Manufacturing, Quality Control, Management, Project Management, Formulation, Process Improvement, Quality Management, Leadership
Education
University of Pittsburgh 1980 — 1985
PhD, Chemistry
The Johns Hopkins University 1976 — 1980
BA, Chemistry
mckeesport high
Donald Wiscaver Jr.'s Validant Experience 2012 - 2014
Job Sr. Validation Engineer
Industry Pharmaceuticals
Experience
Compliance Team, Inc. March 2015 - Present
Commissioning Agents, Inc CAI Consulting August 2014 - March 2015
Validant 2012 - 2014
Jacobs Engineering September 1999 - July 2012
Jacobs Engineering 1999 - 2012
Skills
P&ID, Detail Engineering, Process Simulation, Engineering, Commissioning, EPC, Quality System, Change Control, V&V, Quality Assurance, Inspection, Validation, Piping, Quality Management, PLC, Chemical Engineering, GAMP, SOP, GMP, Pharmaceutical Industry
Education
Rose-Hulman Institute of Technology 1993 — 1995
B.S. ChemE, Chemical Engineering
Vincennes University 1991 — 1993
Associate of Science (A.S.), Chemistry
Compliance Team, Inc. March 2015 - Present
Commissioning Agents, Inc CAI Consulting August 2014 - March 2015
Validant 2012 - 2014
Jacobs Engineering September 1999 - July 2012
Jacobs Engineering 1999 - 2012
Skills
P&ID, Detail Engineering, Process Simulation, Engineering, Commissioning, EPC, Quality System, Change Control, V&V, Quality Assurance, Inspection, Validation, Piping, Quality Management, PLC, Chemical Engineering, GAMP, SOP, GMP, Pharmaceutical Industry
Education
Rose-Hulman Institute of Technology 1993 — 1995
B.S. ChemE, Chemical Engineering
Vincennes University 1991 — 1993
Associate of Science (A.S.), Chemistry
Alice Day alicelday@gmail.com's Validant Experience March 2012 - September 2012
Job Quality and Validation Consultant
Industry Pharmaceuticals
Experience
Shire Principal ConsultantSequence Inc. - Quality and Compliance ServicesNovember 2014 - August 2015
Eliassen Group February 2014 - October 2014
MHG Consulting Inc. June 2013 - February 2014
McNeil Consumer Healthcare October 2012 - May 2013
Validant March 2012 - September 2012
Eliassen Group May 2011 - March 2012
Oxford Global Resources April 2011 - May 2011
ALPCO Diagnostics October 2010 - April 2011
Lonza December 2009 - July 2010
Lonza December 2007 - December 2009
Skills
ISO 13485, Mitigation, cGMP, Validation, GMP, CSV, 21 CFR Part 11, USP <1058>, Change Control, Quality Control, Software Documentation, LIMS, GAMP, USP, CAPA, Quality System, Quality Assurance, Trackwise, FDA, Computer System..., Sop, Microbiology, Chromatography, GxP, Aseptic Processing, Pharmaceutical Industry, V&V, SOP, TrackWise
Education
The University of Georgia 1992 — 1999
MS
The University of Georgia 1987 — 1991
DVM
Shire Principal ConsultantSequence Inc. - Quality and Compliance ServicesNovember 2014 - August 2015
Eliassen Group February 2014 - October 2014
MHG Consulting Inc. June 2013 - February 2014
McNeil Consumer Healthcare October 2012 - May 2013
Validant March 2012 - September 2012
Eliassen Group May 2011 - March 2012
Oxford Global Resources April 2011 - May 2011
ALPCO Diagnostics October 2010 - April 2011
Lonza December 2009 - July 2010
Lonza December 2007 - December 2009
Skills
ISO 13485, Mitigation, cGMP, Validation, GMP, CSV, 21 CFR Part 11, USP <1058>, Change Control, Quality Control, Software Documentation, LIMS, GAMP, USP, CAPA, Quality System, Quality Assurance, Trackwise, FDA, Computer System..., Sop, Microbiology, Chromatography, GxP, Aseptic Processing, Pharmaceutical Industry, V&V, SOP, TrackWise
Education
The University of Georgia 1992 — 1999
MS
The University of Georgia 1987 — 1991
DVM
Ronald Academia's Validant Experience April 2012 - April 2013
Job Quality Engineer at Impax Laboratories
Industry Biotechnology
Experience
Impax Laboratories May 2013 - Present
Validant April 2012 - April 2013
XOMA June 2007 - April 2012
Bio-Rad Laboratories August 2000 - June 2007
Bio-Rad Laboratories 2000 - 2007
Skills
GMP, HPLC, Validation, Change Control, QC, CAPA, GC, USP, EP, ACS, CE-SDS, Wet Chemistry, FTIR, 21 CFR Part 11, Quality Control, Trackwise, Quality Assurance, Chromatography, Biopharmaceuticals, Minitab, ANOVA, Technology Transfer, GxP, SAP ERP, Stability Studies, Trend Forecasting
Education
University of California, Santa Barbara 1997 — 1999
BA, Pre-Dental Japanese
Impax Laboratories May 2013 - Present
Validant April 2012 - April 2013
XOMA June 2007 - April 2012
Bio-Rad Laboratories August 2000 - June 2007
Bio-Rad Laboratories 2000 - 2007
Skills
GMP, HPLC, Validation, Change Control, QC, CAPA, GC, USP, EP, ACS, CE-SDS, Wet Chemistry, FTIR, 21 CFR Part 11, Quality Control, Trackwise, Quality Assurance, Chromatography, Biopharmaceuticals, Minitab, ANOVA, Technology Transfer, GxP, SAP ERP, Stability Studies, Trend Forecasting
Education
University of California, Santa Barbara 1997 — 1999
BA, Pre-Dental Japanese
Kim Drexler, P.E.'s Validant Experience March 2011 - December 2012
Job Owner at Choice Project Management, LLC
Industry Biotechnology
Experience
Shire Pharmaceuticals January 2014 - Present
Choice Project Management, LLC December 2012 - Present
Johnson & Johnson December 2012 - December 2013
Validant March 2011 - December 2012
MannKind Corporation January 2008 - April 2011
MannKind Corporation January 2008 - February 2011
Bristol-Myers Squibb April 1993 - December 2007
UTC Carrier Air Conditioning Corporation December 1986 - February 1992
Skills
GMP Compliance, Project Controls, Code Compliance, Analytics, Process Improvement, Project Management, Strategic Planning, MS Project, Primavera P6, AutoCAD, DDC & HVAC Systems, Energy Management, SharePoint, GMP, Microsoft Office, Green Belt, PMP, Contract Management, Program Management, Quality Control, Quality Assurance, Project Control, Management, Manufacturing, Validation, Microsoft Project, 21 CFR Part 11, Six Sigma, Project Planning, Cross-functional Team..., Sop, FDA, HVAC, Software Documentation, Microsoft Excel, Analysis, Leadership, Engineering, Business Process..., Biotechnology, Code Enforcement, Technology Transfer
Education
University of Hartford 1998 — 2000
MSEE, Graduate Study
University of Connecticut 1980 — 1985
BSEE, Electrical Engineering / Computer Science
Shire Pharmaceuticals January 2014 - Present
Choice Project Management, LLC December 2012 - Present
Johnson & Johnson December 2012 - December 2013
Validant March 2011 - December 2012
MannKind Corporation January 2008 - April 2011
MannKind Corporation January 2008 - February 2011
Bristol-Myers Squibb April 1993 - December 2007
UTC Carrier Air Conditioning Corporation December 1986 - February 1992
Skills
GMP Compliance, Project Controls, Code Compliance, Analytics, Process Improvement, Project Management, Strategic Planning, MS Project, Primavera P6, AutoCAD, DDC & HVAC Systems, Energy Management, SharePoint, GMP, Microsoft Office, Green Belt, PMP, Contract Management, Program Management, Quality Control, Quality Assurance, Project Control, Management, Manufacturing, Validation, Microsoft Project, 21 CFR Part 11, Six Sigma, Project Planning, Cross-functional Team..., Sop, FDA, HVAC, Software Documentation, Microsoft Excel, Analysis, Leadership, Engineering, Business Process..., Biotechnology, Code Enforcement, Technology Transfer
Education
University of Hartford 1998 — 2000
MSEE, Graduate Study
University of Connecticut 1980 — 1985
BSEE, Electrical Engineering / Computer Science
Joyce Chun's Validant Experience 2009 - 2009
Job Research Administrator
Industry Research
Experience
UC Berkeley February 2010 - Present
Elim Biopharmaceuticals, Inc. March 2009 - November 2009
Tutorpedia December 2008 - May 2009
Validant 2009 - 2009
Skills
Microsoft Office, Research, Data Analysis, Nonprofits, Event Planning
Education
University of California, Berkeley 2004 — 2008
BA
UC Berkeley February 2010 - Present
Elim Biopharmaceuticals, Inc. March 2009 - November 2009
Tutorpedia December 2008 - May 2009
Validant 2009 - 2009
Skills
Microsoft Office, Research, Data Analysis, Nonprofits, Event Planning
Education
University of California, Berkeley 2004 — 2008
BA
Dan Suchecki's Validant Experience June 2012 - May 2013
Job Consultant at Validant
Industry Biotechnology
Experience
DME Alliance Engineering Consultants December 2013 - July 2014
Validant June 2012 - May 2013
Sanofi Pasteur June 2007 - January 2012
sanofi pasteur 2007 - January 2012
Merck &Co. Inc. April 1971 - November 2003
Skills
Vaccines, cGMP, Pharmaceuticals, Pharmaceutical Industry, Validation, Change Control, Cleaning Validation, FDA, GLP, V&V, GMP, GxP, Biotechnology, Regulatory Affairs, Biopharmaceuticals, Lifesciences, Computer System..., Technology Transfer, Sop, CAPA, Quality Management, Process Engineering, Quality System, Aseptic Processing, LIMS, Process Simulation, Regulatory Requirements, GAMP, Regulatory Submissions
Education
Penn State University 1967 — 1971
BS, Chemical Engineering
DME Alliance Engineering Consultants December 2013 - July 2014
Validant June 2012 - May 2013
Sanofi Pasteur June 2007 - January 2012
sanofi pasteur 2007 - January 2012
Merck &Co. Inc. April 1971 - November 2003
Skills
Vaccines, cGMP, Pharmaceuticals, Pharmaceutical Industry, Validation, Change Control, Cleaning Validation, FDA, GLP, V&V, GMP, GxP, Biotechnology, Regulatory Affairs, Biopharmaceuticals, Lifesciences, Computer System..., Technology Transfer, Sop, CAPA, Quality Management, Process Engineering, Quality System, Aseptic Processing, LIMS, Process Simulation, Regulatory Requirements, GAMP, Regulatory Submissions
Education
Penn State University 1967 — 1971
BS, Chemical Engineering
W. Paul Findlay, PhD, PMP's Validant Experience October 2014 - June 2015
Job Associate Director, CMC Manufacturing at Keryx Biopharmaceuticals
Industry Pharmaceuticals
Experience
Keryx Biopharmaceuticals June 2015 - Present
St. John's University January 2015 - Present
Validant October 2014 - June 2015
Forest Laboratories May 2010 - March 2014
Forest Laboratories September 2006 - May 2010
Bristol-Myers Squibb May 2003 - September 2006
Purdue University January 1999 - April 2003
Bristol-Myers Squibb November 1990 - December 1998
Monsanto July 1989 - November 1990
Skills
Technology Transfer, Chemistry, Formulation, Pharmaceutical Industry, GMP, GLP, Spectroscopy, Product Development, Characterization, IR, Process Simulation, Analytical Chemistry, Cross-functional Team..., Project Management, Process Development, Quality by Design, Design of Experiments, CMC, Manufacturing Scale-up, Statistical Data...
Education
Purdue University 1999 — 2003
PhD, Industrial and Physical Pharmacy
Seton Hall University
The College of Wooster 1985 — 1989
BA, Chemistry
Keryx Biopharmaceuticals June 2015 - Present
St. John's University January 2015 - Present
Validant October 2014 - June 2015
Forest Laboratories May 2010 - March 2014
Forest Laboratories September 2006 - May 2010
Bristol-Myers Squibb May 2003 - September 2006
Purdue University January 1999 - April 2003
Bristol-Myers Squibb November 1990 - December 1998
Monsanto July 1989 - November 1990
Skills
Technology Transfer, Chemistry, Formulation, Pharmaceutical Industry, GMP, GLP, Spectroscopy, Product Development, Characterization, IR, Process Simulation, Analytical Chemistry, Cross-functional Team..., Project Management, Process Development, Quality by Design, Design of Experiments, CMC, Manufacturing Scale-up, Statistical Data...
Education
Purdue University 1999 — 2003
PhD, Industrial and Physical Pharmacy
Seton Hall University
The College of Wooster 1985 — 1989
BA, Chemistry
Nashoane Fulwood-Kelley's Validant Experience April 2010 - August 2010
Job
Industry Medical Devices
Experience
Medtronic August 2010 - Present
Validant April 2010 - August 2010
Miami Dade College 2003 - April 2010
Johnsons Leadership Consultant 2009 - 2010
Cordis Corporation,a Johnson and Johnson company 2002 - 2009
Miami Heart Institute and Medical Center 1996 - 2002
Skills
FDA, Medical Devices, CAPA, Software Documentation, Quality System, Continuous Improvement, Leadership, Healthcare, Strategic Planning, Clinical Research, ISO 13485, Complaint Management, Quality Assurance, Validation, Cross-functional Team...
Education
BSI Management SystemsTraining-Quality Management Systems
ISO9001:2000 Lead Auditor with Emphasis on ISO13485:2012
Nova Southeastern University
BS, Management, Healthcare Administration
Nova Southeastern University
MS, Computer Technology/Computer Systems Technology
Medtronic August 2010 - Present
Validant April 2010 - August 2010
Miami Dade College 2003 - April 2010
Johnsons Leadership Consultant 2009 - 2010
Cordis Corporation,a Johnson and Johnson company 2002 - 2009
Miami Heart Institute and Medical Center 1996 - 2002
Skills
FDA, Medical Devices, CAPA, Software Documentation, Quality System, Continuous Improvement, Leadership, Healthcare, Strategic Planning, Clinical Research, ISO 13485, Complaint Management, Quality Assurance, Validation, Cross-functional Team...
Education
BSI Management SystemsTraining-Quality Management Systems
ISO9001:2000 Lead Auditor with Emphasis on ISO13485:2012
Nova Southeastern University
BS, Management, Healthcare Administration
Nova Southeastern University
MS, Computer Technology/Computer Systems Technology
Andy Grom's Validant Experience November 2010 - April 2011
Job Director of Quality at Cardiac Science Inc
Industry Medical Devices
Experience
Cardiac Science Inc July 2014 - Present
Cardiac Sciences June 2012 - June 2014
Baxter Healthcare May 2011 - June 2012
Validant November 2010 - April 2011
Maetrics LLC November 2009 - July 2010
Gendex Dental Systems 2008 - 2009
Ohio Medical Corporation 2005 - 2008
Skills
Quality Systems, FDA, Inspection, ISO 13485, Medical Devices, CAPA, ISO, Validation, cGMP, GMP, Quality Assurance, Lean Manufacturing, Compliance, Process Improvement, Continuous Improvement, Pharmaceuticals, Testing, Auditing, Quality Management, Documentation, QSR, 21 CFR Part 11, Software Documentation, Quality System, Quality Auditing, Pharmaceutical Industry, Computer System..., ISO 14971, Sop, Six Sigma, Change Control, Manufacturing, Supplier Quality, Design Control, Process Simulation, Root Cause Analysis, GLP, R&D, Quality Control, V&V, SPC, Minitab, Regulatory Requirements, Regulatory Affairs, FMEA, GxP, DMAIC, Complaint Management, Cross-functional Team..., Biotechnology
Education
Waukegan West High School 1974 — 1978
College Prep
University of Kansas
Bachelor of Arts (BA)
Cardiac Science Inc July 2014 - Present
Cardiac Sciences June 2012 - June 2014
Baxter Healthcare May 2011 - June 2012
Validant November 2010 - April 2011
Maetrics LLC November 2009 - July 2010
Gendex Dental Systems 2008 - 2009
Ohio Medical Corporation 2005 - 2008
Skills
Quality Systems, FDA, Inspection, ISO 13485, Medical Devices, CAPA, ISO, Validation, cGMP, GMP, Quality Assurance, Lean Manufacturing, Compliance, Process Improvement, Continuous Improvement, Pharmaceuticals, Testing, Auditing, Quality Management, Documentation, QSR, 21 CFR Part 11, Software Documentation, Quality System, Quality Auditing, Pharmaceutical Industry, Computer System..., ISO 14971, Sop, Six Sigma, Change Control, Manufacturing, Supplier Quality, Design Control, Process Simulation, Root Cause Analysis, GLP, R&D, Quality Control, V&V, SPC, Minitab, Regulatory Requirements, Regulatory Affairs, FMEA, GxP, DMAIC, Complaint Management, Cross-functional Team..., Biotechnology
Education
Waukegan West High School 1974 — 1978
College Prep
University of Kansas
Bachelor of Arts (BA)
Manuel Pol's Validant Experience April 2013 - Present
Job Sr. Consultant at Validant
Industry Pharmaceuticals
Experience
Validant April 2013 - Present
Noven Pharmaceuticals October 2009 - November 2013
Watson Pharmaceuticals April 2006 - May 2009
Schering-Plough 2003 - 2006
Wyeth Pharmaceuticals 2001 - 2003
Monsanto 2000 - 2001
Ivax Pharmaceuticals 1993 - 2001
Baxter Healthcare 1987 - 1993
Merc, Sharp & Dohme 1983 - June 1987
Skills
FDA, Manufacturing, GMP, Quality Assurance, V&V, 21 CFR Part 11, R&D, Lean Manufacturing, Cleaning Validation, GLP, GxP, Regulatory Affairs, Training, CAPA, Validation, Six Sigma, Sop, Biotechnology, Software Documentation, Quality System, LIMS, Computer System..., Change Control, Trackwise, Technology Transfer, Pharmaceutical Industry, Aseptic Processing, GAMP, SOP, Quality Auditing, Medical Devices, Biopharmaceuticals
Education
SkillPath Corporation 2012 — 2012
Train the Trainer Master Certification
University of Phoenix 2008 — 2010
Master of Business Administration (M.B.A.), Business Administration and Management, General, 3.64 GPA
Pontificia Universidad Católica de Puerto Rico
BS, Chemistry
University of Phoenix
MBA, 3.64 GPA
Validant April 2013 - Present
Noven Pharmaceuticals October 2009 - November 2013
Watson Pharmaceuticals April 2006 - May 2009
Schering-Plough 2003 - 2006
Wyeth Pharmaceuticals 2001 - 2003
Monsanto 2000 - 2001
Ivax Pharmaceuticals 1993 - 2001
Baxter Healthcare 1987 - 1993
Merc, Sharp & Dohme 1983 - June 1987
Skills
FDA, Manufacturing, GMP, Quality Assurance, V&V, 21 CFR Part 11, R&D, Lean Manufacturing, Cleaning Validation, GLP, GxP, Regulatory Affairs, Training, CAPA, Validation, Six Sigma, Sop, Biotechnology, Software Documentation, Quality System, LIMS, Computer System..., Change Control, Trackwise, Technology Transfer, Pharmaceutical Industry, Aseptic Processing, GAMP, SOP, Quality Auditing, Medical Devices, Biopharmaceuticals
Education
SkillPath Corporation 2012 — 2012
Train the Trainer Master Certification
University of Phoenix 2008 — 2010
Master of Business Administration (M.B.A.), Business Administration and Management, General, 3.64 GPA
Pontificia Universidad Católica de Puerto Rico
BS, Chemistry
University of Phoenix
MBA, 3.64 GPA
Keith Duncan's Validant Experience September 2010 - July 2011
Job Medical Device Consultant & Contractor
Industry Medical Devices
Experience
Oxford International June 2014 - April 2015
MAETRICS September 2012 - May 2014
MAETRICS May 2014 - 2014
Oxford Global Resources February 2012 - May 2012
Oxford Global Resources September 2011 - November 2011
Validant September 2010 - July 2011
ConMed Linvatec 2003 - May 2009
Skills
Quality Assurance, Manufacturing, Risk Management, Microsoft Office, ISO 13485, CAPA, Design Control, Product Complaints, ISO 14971, FDA QSR, ASQ CQA, FDA GMP, FMEA, GD&T, Gage R&R, Lean Six Sigma, Six Sigma, Supplier Audit, ISO 9001, Minitab, Lean Manufacturing, Iso 9000, Auditing, FDA, Medical Devices, Quality System, Quality Control, V, Quality Auditing, Root Cause Analysis, Continuous Improvement, Validation, GMP, Process Improvement, Design of Experiments, DMAIC
Education
St. Petersburg College 2012 — 2012
St. Petersburg College 2009 — 2010
Certificate, Six Sigma Black Belt
St. Petersburg College 2009 — 2010
Certificate, Lean Six Sigma Green Belt
St. Petersburg College 2009 — 2010
Certificate, Linux System Administrator
University of South Florida 2001 — 2003
BA, Management Information Systems
St. Petersburg College 1997 — 2000
AA
Tampa Technical Institute 1987 — 1990
BSCET, Computer Engineering Technology
Oxford International June 2014 - April 2015
MAETRICS September 2012 - May 2014
MAETRICS May 2014 - 2014
Oxford Global Resources February 2012 - May 2012
Oxford Global Resources September 2011 - November 2011
Validant September 2010 - July 2011
ConMed Linvatec 2003 - May 2009
Skills
Quality Assurance, Manufacturing, Risk Management, Microsoft Office, ISO 13485, CAPA, Design Control, Product Complaints, ISO 14971, FDA QSR, ASQ CQA, FDA GMP, FMEA, GD&T, Gage R&R, Lean Six Sigma, Six Sigma, Supplier Audit, ISO 9001, Minitab, Lean Manufacturing, Iso 9000, Auditing, FDA, Medical Devices, Quality System, Quality Control, V, Quality Auditing, Root Cause Analysis, Continuous Improvement, Validation, GMP, Process Improvement, Design of Experiments, DMAIC
Education
St. Petersburg College 2012 — 2012
St. Petersburg College 2009 — 2010
Certificate, Six Sigma Black Belt
St. Petersburg College 2009 — 2010
Certificate, Lean Six Sigma Green Belt
St. Petersburg College 2009 — 2010
Certificate, Linux System Administrator
University of South Florida 2001 — 2003
BA, Management Information Systems
St. Petersburg College 1997 — 2000
AA
Tampa Technical Institute 1987 — 1990
BSCET, Computer Engineering Technology
Henry (Hank) Howell's Validant Experience March 2012 - Present
Job Subject Matter Expert QC at Validant
Industry Pharmaceuticals
Experience
Validant March 2012 - Present
Consulting in Quality and Pharmaceutical Science May 2007 - June 2009
Surface Logix May 2007 - May 2009
Cubist Pharmaceuticals November 2004 - May 2007
Johnson Matthey / Pharmaceutical Materials 1994 - 2003
Bristol Myers Squibb Syracuse NY June 1990 - December 1994
Bristol-Myers Squibb 1969 - 1994
Bristol Myers Syracuse NY December 1982 - December 1990
Bristol Myers Syracuse NY November 1980 - December 1982
Bristol Myers Syracuse NY December 1970 - November 1981
Skills
FDA, Quality System, Sop, Quality Control, Quality Auditing, Validation, GMP, V&V, Biotechnology, Change Control, Analytical Chemistry, Regulatory Affairs, Medical Devices, Lifesciences, Pharmaceutical Industry
Education
Syracuse University 1968 — 1970
BS & MS, Organuic Chemistry
State University of New York College of Environmental Sciences and Forestry 1963 — 1969
BS, MS, Organic Chemistry
Validant March 2012 - Present
Consulting in Quality and Pharmaceutical Science May 2007 - June 2009
Surface Logix May 2007 - May 2009
Cubist Pharmaceuticals November 2004 - May 2007
Johnson Matthey / Pharmaceutical Materials 1994 - 2003
Bristol Myers Squibb Syracuse NY June 1990 - December 1994
Bristol-Myers Squibb 1969 - 1994
Bristol Myers Syracuse NY December 1982 - December 1990
Bristol Myers Syracuse NY November 1980 - December 1982
Bristol Myers Syracuse NY December 1970 - November 1981
Skills
FDA, Quality System, Sop, Quality Control, Quality Auditing, Validation, GMP, V&V, Biotechnology, Change Control, Analytical Chemistry, Regulatory Affairs, Medical Devices, Lifesciences, Pharmaceutical Industry
Education
Syracuse University 1968 — 1970
BS & MS, Organuic Chemistry
State University of New York College of Environmental Sciences and Forestry 1963 — 1969
BS, MS, Organic Chemistry
Steve Asher's Validant Experience March 2012 - Present
Job Consutant at Validant
Industry Mechanical or Industrial Engineering
Experience
Validant March 2012 - Present
Total Systems Design June 2004 - June 2010
STERIS Corporation 1999 - 2002
Skills
GMP, Sop, Change Control, FDA, Quality System, 21 CFR Part 11, CAPA, V&V, Computer System..., ISO 13485, Validation
Education
University of Missouri-Columbia
Bachelor of Science (B.S.), Mechanical Engineering
Validant March 2012 - Present
Total Systems Design June 2004 - June 2010
STERIS Corporation 1999 - 2002
Skills
GMP, Sop, Change Control, FDA, Quality System, 21 CFR Part 11, CAPA, V&V, Computer System..., ISO 13485, Validation
Education
University of Missouri-Columbia
Bachelor of Science (B.S.), Mechanical Engineering
Deepa Adiga's Validant Experience January 2014 - April 2014
Job Director, Regulatory Affairs at Granules USA, Inc.
Industry Pharmaceuticals
Experience
Granules USA, Inc. May 2014 - Present
Validant January 2014 - April 2014
Novartis Animal Health US, Inc. 2009 - 2012
Rite Aid September 2008 - April 2009
Par Pharmaceutical December 2001 - September 2008
Skills
Regulatory Affairs, Regulatory Submissions, Pharmaceutical Industry, Regulatory Requirements, FDA, SOP, ANDA, GMP, Regulatory Strategy..., CMC, CMC Regulatory Affairs, eCTD, Pharmaceutics, Pharmacovigilance, Analytical Chemistry, 21 CFR Part 11, Dissolution, GLP, DMF, Generic Drugs, Change Control, HPLC, Analytical Method...
Education
Rajiv Gandhi University of Health Sciences 1997 — 2001
Bachelor Pharmacy, Pharmacy
Granules USA, Inc. May 2014 - Present
Validant January 2014 - April 2014
Novartis Animal Health US, Inc. 2009 - 2012
Rite Aid September 2008 - April 2009
Par Pharmaceutical December 2001 - September 2008
Skills
Regulatory Affairs, Regulatory Submissions, Pharmaceutical Industry, Regulatory Requirements, FDA, SOP, ANDA, GMP, Regulatory Strategy..., CMC, CMC Regulatory Affairs, eCTD, Pharmaceutics, Pharmacovigilance, Analytical Chemistry, 21 CFR Part 11, Dissolution, GLP, DMF, Generic Drugs, Change Control, HPLC, Analytical Method...
Education
Rajiv Gandhi University of Health Sciences 1997 — 2001
Bachelor Pharmacy, Pharmacy
Linda Glosser's Validant Experience 2011 - 2012
Job Validation Engineer
Industry Biotechnology
Experience
Validant 2011 - 2012
Pfizer Pharmaceuticals January 2004 - May 2007
Education
University of Cincinnati 2004 — 2007
B.S., Chemistry
Validant 2011 - 2012
Pfizer Pharmaceuticals January 2004 - May 2007
Education
University of Cincinnati 2004 — 2007
B.S., Chemistry
Susan Curry's Validant Experience 2010 - 2011
Job Project Quality Manager at Black & Veatch
Industry Design
Experience
Black & Veatch August 2011 - Present
Validant 2010 - 2011
Nexus Medical LLC and EntraCare LLC February 2009 - October 2010
Interconnect Devices, Inc January 2004 - February 2009
Susan Curry Consulting July 2000 - April 2003
Davol, Inc. / CR Bard April 1996 - May 2000
TRW-Electronic Systems Group September 1987 - August 1988
TRW-Electronic Systems Group March 1983 - September 1987
NCR May 1981 - March 1983
Education
School name:
The University of Texas at Austin
B.A., Psychology
University of Colorado Colorado Springs
B.S., Electrical Engineering
Black & Veatch August 2011 - Present
Validant 2010 - 2011
Nexus Medical LLC and EntraCare LLC February 2009 - October 2010
Interconnect Devices, Inc January 2004 - February 2009
Susan Curry Consulting July 2000 - April 2003
Davol, Inc. / CR Bard April 1996 - May 2000
TRW-Electronic Systems Group September 1987 - August 1988
TRW-Electronic Systems Group March 1983 - September 1987
NCR May 1981 - March 1983
Education
School name:
The University of Texas at Austin
B.A., Psychology
University of Colorado Colorado Springs
B.S., Electrical Engineering
Fertac Bilge's Validant Experience June 2015 - Present
Job Consultant at Validant
Industry Medical Devices
Experience
Validant June 2015 - Present
Helix Medical October 2013 - Present
Terumo Medical Corporation March 2011 - April 2013
Covidien December 2009 - January 2011
Thoratec 2006 - 2009
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY 2003 - 2006
Medtronic Vascular 1999 - 2003
Mentor Medical Systems 1994 - 1998
Skills
Medical Devices, Product Development, ISO 13485, Design Control, Project Management, FDA, Biomedical Engineering, Quality System, CAPA, V&V, R&D, Cross-functional Team...
Education
The University of Texas Southwestern Medical Center at Dallas 1977 — 1981
Ph.D., Biomedical engineering
Texas A&M University
M.S., Biomedical Engineering
Validant June 2015 - Present
Helix Medical October 2013 - Present
Terumo Medical Corporation March 2011 - April 2013
Covidien December 2009 - January 2011
Thoratec 2006 - 2009
CORDIS CORPORATION, A JOHNSON AND JOHNSON COMPANY 2003 - 2006
Medtronic Vascular 1999 - 2003
Mentor Medical Systems 1994 - 1998
Skills
Medical Devices, Product Development, ISO 13485, Design Control, Project Management, FDA, Biomedical Engineering, Quality System, CAPA, V&V, R&D, Cross-functional Team...
Education
The University of Texas Southwestern Medical Center at Dallas 1977 — 1981
Ph.D., Biomedical engineering
Texas A&M University
M.S., Biomedical Engineering
Jennifer Ross Allen's Validant Experience February 2012 - September 2012
Job Biopharmaceutical Consultant
Industry Biotechnology
Experience
J. Ross Allen & Associates, Inc. September 2012 - Present
Validant February 2012 - September 2012
Teva Pharmaceutical Industries Ltd. August 2011 - February 2012
PYRAMID Laboratories May 2011 - August 2011
Amgen 2005 - 2011
Stason Pharmaceuticals June 2004 - February 2005
Skills
CAPA, FDA GMP, 21 CFR Part 11, Complaint Investigations, Project Management, Quality Assurance, Quality System..., Pharmaceutical Industry, Process Improvement, Proposal Writing, Batch Release, Lean Manufacturing, Deviations, Aseptic Processing, Environmental Monitoring, Technical Writing, Document Management, Clinical Manufacturing, Commercial Manufacturing, Training Delivery, Iso 9000, Biotechnology, Leadership, Strategic Planning, Coaching Staff, Validation, cGMP manufacturing, Manufacturing, Cleaning Validation, Root Cause Analysis, Training, Lifesciences, Vaccines, Regulatory Requirements, Cross-functional Team..., GxP, Pharmaceutics, Chromatography, Quality Auditing, Regulatory Affairs, Life Sciences, GMP, FDA, SOP, Quality System, Change Control, Biopharmaceuticals
Education
University of California, Irvine 1998 — 2003
B.S., Biological Sciences with Specialization in Neuroscience
Stanford University
Strategic Decision and Risk Management
University of California, Berkeley
Project Management
J. Ross Allen & Associates, Inc. September 2012 - Present
Validant February 2012 - September 2012
Teva Pharmaceutical Industries Ltd. August 2011 - February 2012
PYRAMID Laboratories May 2011 - August 2011
Amgen 2005 - 2011
Stason Pharmaceuticals June 2004 - February 2005
Skills
CAPA, FDA GMP, 21 CFR Part 11, Complaint Investigations, Project Management, Quality Assurance, Quality System..., Pharmaceutical Industry, Process Improvement, Proposal Writing, Batch Release, Lean Manufacturing, Deviations, Aseptic Processing, Environmental Monitoring, Technical Writing, Document Management, Clinical Manufacturing, Commercial Manufacturing, Training Delivery, Iso 9000, Biotechnology, Leadership, Strategic Planning, Coaching Staff, Validation, cGMP manufacturing, Manufacturing, Cleaning Validation, Root Cause Analysis, Training, Lifesciences, Vaccines, Regulatory Requirements, Cross-functional Team..., GxP, Pharmaceutics, Chromatography, Quality Auditing, Regulatory Affairs, Life Sciences, GMP, FDA, SOP, Quality System, Change Control, Biopharmaceuticals
Education
University of California, Irvine 1998 — 2003
B.S., Biological Sciences with Specialization in Neuroscience
Stanford University
Strategic Decision and Risk Management
University of California, Berkeley
Project Management
Mark Eugster's Validant Experience April 2012 - May 2012
Job Senior Packaging Engineer
Industry Medical Devices
Experience
Ethicon February 2013 - Present
Equity Packaging January 2013 - Present
Institute of Packaging Professionals 2006 - Present
Validant April 2012 - May 2012
Merck & Co., Inc. November 2009 - September 2010
Schering-Plough Research Institute 1999 - November 2009
Institute of Packaging Professionals 2003 - 2006
Institute of Packaging Professionals August 1992 - 2006
Almedica Services Corp., 1995 - 1999
Meadox Medicals, Inc. 1991 - 1993
Skills
GMP, Pharmaceutical Industry, Validation, R&D, Packaging, Quality Assurance, Web Design, LIMS, cGMP, Clinical Trials, Supply Chain, CAPA, Pharmaceutics, FDA, ISPE, Consent Decree, Continuous Improvement, Product Development, Plastics, Medical Devices, V&V, Quality Control, Quality System, 21 CFR Part 11, Commercialization, Change Control, Cross-functional Team..., Sop, Technology Transfer
Education
Rutgers, The State University of New Jersey-New Brunswick 2011 — 2011
Mini-MBA™, BioPharma Innovation
Rochester Institute of Technology
BS, Packaging Science
Ethicon February 2013 - Present
Equity Packaging January 2013 - Present
Institute of Packaging Professionals 2006 - Present
Validant April 2012 - May 2012
Merck & Co., Inc. November 2009 - September 2010
Schering-Plough Research Institute 1999 - November 2009
Institute of Packaging Professionals 2003 - 2006
Institute of Packaging Professionals August 1992 - 2006
Almedica Services Corp., 1995 - 1999
Meadox Medicals, Inc. 1991 - 1993
Skills
GMP, Pharmaceutical Industry, Validation, R&D, Packaging, Quality Assurance, Web Design, LIMS, cGMP, Clinical Trials, Supply Chain, CAPA, Pharmaceutics, FDA, ISPE, Consent Decree, Continuous Improvement, Product Development, Plastics, Medical Devices, V&V, Quality Control, Quality System, 21 CFR Part 11, Commercialization, Change Control, Cross-functional Team..., Sop, Technology Transfer
Education
Rutgers, The State University of New Jersey-New Brunswick 2011 — 2011
Mini-MBA™, BioPharma Innovation
Rochester Institute of Technology
BS, Packaging Science
GLADYS ALICEA's Validant Experience March 2013 - June 2013
Job QA/QC Compliance Quality Consultant
Industry Pharmaceuticals
Experience
Quantic Group July 2015 - Present
GK Regulatory, Compliance & Engineering Consulting LLC October 2014 - January 2015
QSC, Inc. January 2014 - June 2014
PECS, Inc. December 2013 - January 2014
LATFAR Consulting Services July 2013 - July 2013
Validant March 2013 - June 2013
Noonday Sun Equities, LP (Consultants) November 2012 - December 2012
Pharmaceutical Engineering Consulting Services (PECS) September 2011 - November 2012
Pharmaceutical Engineering Consulting Services, Inc. (P.E.C.S., Inc.) November 2010 - March 2011
PepsiCo, Cidra November 2009 - December 2009
Skills
Supervisory Experience, Chemistry, Compliance, CAPA, SOPs, Quality System, Six Sigma, Teamwork, Investigation, cGMP, Validation, Change Control, FDA inspections, LIMS, Cleaning Validation, 21 CFR Part 11, Regulatory Audits, Empower, HPLC, USP, GMP, GLP, Laboratory Medicine, Quality Management, Deviations, Quality Control, Quality Assurance, FDA, Industria farmacéutica, SOP, Acciones correctivas y..., POE, Buenas prácticas de..., Administración de..., Seis Sigma, Validación de limpieza, Gestión de la calidad, Química, Sistema de gestión de..., Validación
Education
Sacred Heart University
Bachelor Degree, Chemistry
University of Puerto Rico
Bachelor's Degree, Mathematics
Quantic Group July 2015 - Present
GK Regulatory, Compliance & Engineering Consulting LLC October 2014 - January 2015
QSC, Inc. January 2014 - June 2014
PECS, Inc. December 2013 - January 2014
LATFAR Consulting Services July 2013 - July 2013
Validant March 2013 - June 2013
Noonday Sun Equities, LP (Consultants) November 2012 - December 2012
Pharmaceutical Engineering Consulting Services (PECS) September 2011 - November 2012
Pharmaceutical Engineering Consulting Services, Inc. (P.E.C.S., Inc.) November 2010 - March 2011
PepsiCo, Cidra November 2009 - December 2009
Skills
Supervisory Experience, Chemistry, Compliance, CAPA, SOPs, Quality System, Six Sigma, Teamwork, Investigation, cGMP, Validation, Change Control, FDA inspections, LIMS, Cleaning Validation, 21 CFR Part 11, Regulatory Audits, Empower, HPLC, USP, GMP, GLP, Laboratory Medicine, Quality Management, Deviations, Quality Control, Quality Assurance, FDA, Industria farmacéutica, SOP, Acciones correctivas y..., POE, Buenas prácticas de..., Administración de..., Seis Sigma, Validación de limpieza, Gestión de la calidad, Química, Sistema de gestión de..., Validación
Education
Sacred Heart University
Bachelor Degree, Chemistry
University of Puerto Rico
Bachelor's Degree, Mathematics
Minny Chang, RN BSN's Validant Experience August 2013 - September 2015
Job Subject Matter Expert in Drug Safety and Medical Device
Industry Medical Devices
Experience
QualityHub, Inc. November 2014 - Present
Validant August 2013 - September 2015
Maetrics, LLC June 2013 - August 2013
International Services, LLC September 2012 - May 2013
UCB Pharma March 2011 - September 2012
Quintiles December 2010 - March 2011
Biogen Idec November 2006 - October 2010
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2006 - August 2006
Novartis April 2005 - April 2006
PFIZER PHARMACEUTICALS (K-force Agency) May 2004 - April 2005
Skills
Clinical Research, Training, Oncology, Vendor Management, Biotechnology, Clinical Trials, ICH-GCP, Healthcare, Regulatory Affairs, Pharmacovigilance, CRO, Sop, FDA, Medical Devices, Software Documentation, Quality Assurance, Pharmaceutical Industry, SOP, Clinical Development, GCP, Life Sciences, Regulatory Submissions, CTMS, Cross-functional Team..., Cardiology, Neurology, Drug Development, Infectious Diseases, Medical Affairs, Pharmaceutics
Education
Rutgers, The State University of New Jersey-Newark 1990 — 1994
BSN, Nursing
Cedar Ridge High School
QualityHub, Inc. November 2014 - Present
Validant August 2013 - September 2015
Maetrics, LLC June 2013 - August 2013
International Services, LLC September 2012 - May 2013
UCB Pharma March 2011 - September 2012
Quintiles December 2010 - March 2011
Biogen Idec November 2006 - October 2010
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company May 2006 - August 2006
Novartis April 2005 - April 2006
PFIZER PHARMACEUTICALS (K-force Agency) May 2004 - April 2005
Skills
Clinical Research, Training, Oncology, Vendor Management, Biotechnology, Clinical Trials, ICH-GCP, Healthcare, Regulatory Affairs, Pharmacovigilance, CRO, Sop, FDA, Medical Devices, Software Documentation, Quality Assurance, Pharmaceutical Industry, SOP, Clinical Development, GCP, Life Sciences, Regulatory Submissions, CTMS, Cross-functional Team..., Cardiology, Neurology, Drug Development, Infectious Diseases, Medical Affairs, Pharmaceutics
Education
Rutgers, The State University of New Jersey-Newark 1990 — 1994
BSN, Nursing
Cedar Ridge High School
Margaretta Sweezy's Validant Experience December 2012 - Present
Job Senior Talent Acquisition Consultant Recruiter for Validant Strategic Consulting
Industry Staffing and Recruiting
Experience
Validant December 2012 - Present
Lab Support & On Assignment Engineering June 2010 - December 2012
EXPRESS December 2006 - June 2010
Skills
Recruiting, Temporary Placement, Biotechnology, Staffing Services, Leadership, Technical Recruiting, Applicant Tracking..., Sourcing, Internet Recruiting, Quality Assurance, Medical Devices, Temporary Staffing, Talent Acquisition, Contract Recruitment, Laboratory, Screening Resumes, HPLC, Executive Search, College Recruiting, Sales, Cold Calling, Screening, Permanent Placement, Onboarding, Interviews, Resume Writing, Benefits Negotiation, UV/Vis, LinkedIn Recruiter, Full-life Cycle..., Human Resources
Education
San Francisco State University
B.S., Biochemistry
Validant December 2012 - Present
Lab Support & On Assignment Engineering June 2010 - December 2012
EXPRESS December 2006 - June 2010
Skills
Recruiting, Temporary Placement, Biotechnology, Staffing Services, Leadership, Technical Recruiting, Applicant Tracking..., Sourcing, Internet Recruiting, Quality Assurance, Medical Devices, Temporary Staffing, Talent Acquisition, Contract Recruitment, Laboratory, Screening Resumes, HPLC, Executive Search, College Recruiting, Sales, Cold Calling, Screening, Permanent Placement, Onboarding, Interviews, Resume Writing, Benefits Negotiation, UV/Vis, LinkedIn Recruiter, Full-life Cycle..., Human Resources
Education
San Francisco State University
B.S., Biochemistry
Dale Holz's Validant Experience July 2010 - December 2010
Job Plant Manager at Hawkins Chemical
Industry
Experience
Hawkins Chemical December 2010 - Present
Validant July 2010 - December 2010
KV Pharmaceutical October 1993 - March 2010
Education
Southeast Missouri State University
BS, Business Administration
Hawkins Chemical December 2010 - Present
Validant July 2010 - December 2010
KV Pharmaceutical October 1993 - March 2010
Education
Southeast Missouri State University
BS, Business Administration
Anthony Donetz's Validant Experience April 2011 - Present
Job Sr. Complaints/ Medical Events Specialist at Validant
Industry Medical Devices
Experience
Validant April 2011 - Present
ETHICON, INC January 1997 - November 2010
RWJ PHARMACEUTICAL RESEARCH INSTITUTE January 1993 - January 1997
ETHICON INC January 1991 - January 1993
Robert Wood Johnson Medical School January 1985 - January 1991
Skills
MDR - Medical Device..., ISO 13485, Medical Devices, Validation, Quality Assurance, Report Writing, Clinical Research, Laboratory, Operating Room, FDA, Quality System, Assay Development, Biochemistry, Regulatory Affairs, Time Management, Adverse Event Reporting, ISO, Product Launch, Market Development, Capital Equipment, Pharmaceutical Industry
Education
Ramapo College of New Jersey 1972 — 1977
BS, Science
Rutgers University
Post, Cell Biology, Molecular Biology and Immunology
Validant April 2011 - Present
ETHICON, INC January 1997 - November 2010
RWJ PHARMACEUTICAL RESEARCH INSTITUTE January 1993 - January 1997
ETHICON INC January 1991 - January 1993
Robert Wood Johnson Medical School January 1985 - January 1991
Skills
MDR - Medical Device..., ISO 13485, Medical Devices, Validation, Quality Assurance, Report Writing, Clinical Research, Laboratory, Operating Room, FDA, Quality System, Assay Development, Biochemistry, Regulatory Affairs, Time Management, Adverse Event Reporting, ISO, Product Launch, Market Development, Capital Equipment, Pharmaceutical Industry
Education
Ramapo College of New Jersey 1972 — 1977
BS, Science
Rutgers University
Post, Cell Biology, Molecular Biology and Immunology
Robert Dick's Validant Experience August 2011 - August 2013
Job Risk Management, Design Control, Production and Process Control SME at Validant
Industry Medical Devices
Experience
Advanced Sterilization Products September 2013 - January 2015
Validant August 2011 - August 2013
Terumo Cardiovascular Systems 2011 - 2013
CareFusion May 2007 - October 2010
Viasys HealthCare2003 May 2003 - 2007
Newport Medical Instruments, Inc January 1995 - January 2002
Bear Medical Systems, Inc January 1992 - January 1995
Alcon/Coopervision/Cilco January 1985 - January 1992
Skills
CAPA, FDA, Quality Systems, Validation, Quality Assurance, Design Control, Risk Management, ISO 13485, ISO 14971, ISO 14001, ISO 27001, 21 CFR Part 11, ISO 17025, V&V, Gage R&R, Test Method Validation, GMP, DMAIC, Lean Manufacturing, Root Cause Analysis, Consent Decree
Education
Cal State University, Long Beach
BSEE, Biomedical/Clinical
University of Phoenix
MBA, Technology Management
Advanced Sterilization Products September 2013 - January 2015
Validant August 2011 - August 2013
Terumo Cardiovascular Systems 2011 - 2013
CareFusion May 2007 - October 2010
Viasys HealthCare2003 May 2003 - 2007
Newport Medical Instruments, Inc January 1995 - January 2002
Bear Medical Systems, Inc January 1992 - January 1995
Alcon/Coopervision/Cilco January 1985 - January 1992
Skills
CAPA, FDA, Quality Systems, Validation, Quality Assurance, Design Control, Risk Management, ISO 13485, ISO 14971, ISO 14001, ISO 27001, 21 CFR Part 11, ISO 17025, V&V, Gage R&R, Test Method Validation, GMP, DMAIC, Lean Manufacturing, Root Cause Analysis, Consent Decree
Education
Cal State University, Long Beach
BSEE, Biomedical/Clinical
University of Phoenix
MBA, Technology Management
Brad Ballard's Validant Experience January 2012 - Present
Job Operations Manager at Medifast, Inc
Industry Pharmaceuticals
Experience
Medifast, Inc September 2014 - Present
Validant January 2012 - Present
AstraZeneca November 2006 - December 2011
AstraZeneca June 2000 - November 2006
AstraZeneca Pharmaceuticals April 1999 - May 2000
Goldman Paper Group September 1998 - April 1999
Toys R Us June 1997 - August 1998
Skills
SAP ERP, SAP R/3, SAP BW, Distribution Center..., Distribution..., Year-end Close, Sarbanes-Oxley, Temperature Controlled, Temperature Measurement, Project Management, Computer System..., Transportation Planning, FDA GMP, SAP Warehouse Management, Warehouse Management, Customer Service
Education
Saint Joseph's University 2002 — 2004
Master of Business Adminstration, General Management
St. Joseph’s University
MBA
The Pennsylvania State Univeristy 1993 — 1997
Bachelor of Science, Business Logistics
Marple Newtown
Medifast, Inc September 2014 - Present
Validant January 2012 - Present
AstraZeneca November 2006 - December 2011
AstraZeneca June 2000 - November 2006
AstraZeneca Pharmaceuticals April 1999 - May 2000
Goldman Paper Group September 1998 - April 1999
Toys R Us June 1997 - August 1998
Skills
SAP ERP, SAP R/3, SAP BW, Distribution Center..., Distribution..., Year-end Close, Sarbanes-Oxley, Temperature Controlled, Temperature Measurement, Project Management, Computer System..., Transportation Planning, FDA GMP, SAP Warehouse Management, Warehouse Management, Customer Service
Education
Saint Joseph's University 2002 — 2004
Master of Business Adminstration, General Management
St. Joseph’s University
MBA
The Pennsylvania State Univeristy 1993 — 1997
Bachelor of Science, Business Logistics
Marple Newtown
Jason Kindle's Validant Experience January 2012 - Present
Job Consultant at Validant
Industry Pharmaceuticals
Experience
Validant January 2012 - Present
Pfizer July 2010 - October 2011
Pfizer August 2006 - June 2010
Pfizer September 2002 - August 2006
Skills
quality assurance, business process..., Quality Systems, Quality Management, Pharmaceutical..., Regulatory Documentation, Pharmaceuticals, Biotechnology, Biopharmaceuticals, Regulatory Filings, CAPA, cGMP, Protocol Writing, Change Control, Computer System..., Validation, LIMS, Quality Assurance, Pharmaceutical Industry, GMP, Quality System, Sop, GLP, Business Process..., Software Documentation, SOP
Education
University of Missouri-Columbia 1997 — 2002
MS, Biochemistry
University of Missouri-Rolla 1992 — 1997
BS, Life Sciences
Validant January 2012 - Present
Pfizer July 2010 - October 2011
Pfizer August 2006 - June 2010
Pfizer September 2002 - August 2006
Skills
quality assurance, business process..., Quality Systems, Quality Management, Pharmaceutical..., Regulatory Documentation, Pharmaceuticals, Biotechnology, Biopharmaceuticals, Regulatory Filings, CAPA, cGMP, Protocol Writing, Change Control, Computer System..., Validation, LIMS, Quality Assurance, Pharmaceutical Industry, GMP, Quality System, Sop, GLP, Business Process..., Software Documentation, SOP
Education
University of Missouri-Columbia 1997 — 2002
MS, Biochemistry
University of Missouri-Rolla 1992 — 1997
BS, Life Sciences
Brian Pillsbury's Validant Experience December 2012 - June 2013
Job Quality Contractor for Aerotek at Ethicon
Industry Pharmaceuticals
Experience
Aerotek June 2015 - Present
G&W Laboratories October 2013 - Present
Validant December 2012 - June 2013
OraPharma Inc. March 2012 - December 2012
Ortho Clinical Diagnostics 2007 - 2011
Ortho Clinical Diagnostics 1999 - 2007
Huntingdon Life Sciences 1993 - 1999
Huntingdon Life Sciences 1988 - 1993
Huntingdon Life Sciences 1984 - 1988
Skills
FDA, CAPA, GMP, Change Control, GLP, Sop, 21 CFR Part 11, Excel, Quality Assurance, Root Cause Analysis, GxP, Analytical Chemistry, Quality Management, ISO 13485, Six Sigma, HPLC, LIMS, GAMP, Quality Auditing, Minitab, Design Control, Wet Chemistry, Spreadsheet Design, Instrument Validation, Gas Chromatography, Laboratory Automation, Raw Materials, Calibration, General Chemistry, Laboratory Experience, Atomic Absorption, Spreadsheet Validation, Lean Sigma, Green Belt, Software Validation, IQ/OQ/PQ, OOS/OOT Principles &..., Managing Employees, Training & Development, SOX, Internal Audit, External Audit, Electronic Signatures, VBA, cGMP, Process Validation, Quality Systems, QC, Validations, Validation
Education
Stevens Institute of Technology
Chemical Engineering
Thomas Edison State College
Bachelor's Degree
Aerotek June 2015 - Present
G&W Laboratories October 2013 - Present
Validant December 2012 - June 2013
OraPharma Inc. March 2012 - December 2012
Ortho Clinical Diagnostics 2007 - 2011
Ortho Clinical Diagnostics 1999 - 2007
Huntingdon Life Sciences 1993 - 1999
Huntingdon Life Sciences 1988 - 1993
Huntingdon Life Sciences 1984 - 1988
Skills
FDA, CAPA, GMP, Change Control, GLP, Sop, 21 CFR Part 11, Excel, Quality Assurance, Root Cause Analysis, GxP, Analytical Chemistry, Quality Management, ISO 13485, Six Sigma, HPLC, LIMS, GAMP, Quality Auditing, Minitab, Design Control, Wet Chemistry, Spreadsheet Design, Instrument Validation, Gas Chromatography, Laboratory Automation, Raw Materials, Calibration, General Chemistry, Laboratory Experience, Atomic Absorption, Spreadsheet Validation, Lean Sigma, Green Belt, Software Validation, IQ/OQ/PQ, OOS/OOT Principles &..., Managing Employees, Training & Development, SOX, Internal Audit, External Audit, Electronic Signatures, VBA, cGMP, Process Validation, Quality Systems, QC, Validations, Validation
Education
Stevens Institute of Technology
Chemical Engineering
Thomas Edison State College
Bachelor's Degree
Shawn Cook's Validant Experience August 2012 - October 2012
Job Pharmaceutical Quality Consultant
Industry Pharmaceuticals
Experience
Advent Biotech 2013 - Present
Oxford International October 2012 - December 2012
Validant August 2012 - October 2012
Array BioPharma 2006 - 2012
RxKinetix May 2000 - September 2005
Whole Foods 1998 - 2000
Hauser Chemical 1992 - 1998
Education
University of Colorado Boulder 1986 — 1991
BA, Biochemistry, Molecular Biology
Advent Biotech 2013 - Present
Oxford International October 2012 - December 2012
Validant August 2012 - October 2012
Array BioPharma 2006 - 2012
RxKinetix May 2000 - September 2005
Whole Foods 1998 - 2000
Hauser Chemical 1992 - 1998
Education
University of Colorado Boulder 1986 — 1991
BA, Biochemistry, Molecular Biology
Ken Will's Validant Experience 2014 - Present
Job PostMarket Clinical Specialist at VALIDANT
Industry Medical Devices
Experience
VALIDANT 2014 - Present
KINETIC CONCEPTS, INC. 2008 - 2014
KINETIC CONCEPTS, INC. (CONTINUED) 1998 - 2008
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Windows, Outlook, Strategic Planning, Budgets, ISO 13485, ISO 9000, ISO, Pilgrim, Oracle Applications, SAP, Remediation, FDA GMP, Business Process, Business Process..., Problem Solving, Collaborative Problem..., FDA, Management
Education
The Ohio State University
Bachelor's Degree, International Economics
VALIDANT 2014 - Present
KINETIC CONCEPTS, INC. 2008 - 2014
KINETIC CONCEPTS, INC. (CONTINUED) 1998 - 2008
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Windows, Outlook, Strategic Planning, Budgets, ISO 13485, ISO 9000, ISO, Pilgrim, Oracle Applications, SAP, Remediation, FDA GMP, Business Process, Business Process..., Problem Solving, Collaborative Problem..., FDA, Management
Education
The Ohio State University
Bachelor's Degree, International Economics