Validant Consulting
Description
Address: 475 Sansome St, San Francisco, CA 94111 Phone: (415) 400-2600: : Hours: : : : Website: : Category: Place name: Website: http://www.validant.com/contact/ Category: Consultant Suggest an editUnable to add this file. Please check that it is a valid photo. Unable to add this file. Please check that it is a valid photo. · Own this business?Add missing informationAdd business hours Unable to add this file. Please check that it is a valid photo. Questions & answers Ask a questionBe the first to ask a question Add a photoThanks for sharing!Your photo will be posted publicly on Google.Contribute MoreDoneUpload public photos of Validant Posting publicly on the Web Write a review Reviews Be the first to review
Validant Consulting List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at Validant Consulting. You can filter them based on skills, years of employment, job, education, department, and prior employment.
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Validant Consulting Employees
Employee
Years
Job
Industry
Joseph Alec McConnell Joseph Alec McConnell's Validant Consulting Experience April 2013 - February 2014
Job Compliance Specialist at VinGo
Industry Wine and Spirits
Experience
Williams Selyem Winery August 2014 - October 2014
Validant Consulting April 2013 - February 2014
Silver Oak Cellars August 2012 - December 2012
Sports Club (UNC at Chapel Hill) August 2008 - July 2012
Calisolar June 2011 - July 2011
Skills
Matlab, Presentations, Geology surveying, Teaching skills, Heavy equipment skills, Translation skills, Map reading, Environmental consulting, Forklift operator, Public speaking, Geographic Information..., Microsoft Excel, Microsoft Word, Microsoft Power Point, Public Speaking, PowerPoint, Teaching, Market Research, Environmental Consulting, Social Networking, Translation, Forklift Operator, Cultural Awareness, Maps, International Business
Education
University of North Carolina at Chapel Hill 2008 — 2012
Bachelor of Arts, Environmental Studies
Highlands Biological Station (HBS) 2011 — 2011
Ecology
School Year Abroad (BeiJing, China) 2006 — 2007
Chinese Language and Literature
National Outdoor Leadership School (NOLS) 2006 — 2006
American School in London
Williams Selyem Winery August 2014 - October 2014
Validant Consulting April 2013 - February 2014
Silver Oak Cellars August 2012 - December 2012
Sports Club (UNC at Chapel Hill) August 2008 - July 2012
Calisolar June 2011 - July 2011
Skills
Matlab, Presentations, Geology surveying, Teaching skills, Heavy equipment skills, Translation skills, Map reading, Environmental consulting, Forklift operator, Public speaking, Geographic Information..., Microsoft Excel, Microsoft Word, Microsoft Power Point, Public Speaking, PowerPoint, Teaching, Market Research, Environmental Consulting, Social Networking, Translation, Forklift Operator, Cultural Awareness, Maps, International Business
Education
University of North Carolina at Chapel Hill 2008 — 2012
Bachelor of Arts, Environmental Studies
Highlands Biological Station (HBS) 2011 — 2011
Ecology
School Year Abroad (BeiJing, China) 2006 — 2007
Chinese Language and Literature
National Outdoor Leadership School (NOLS) 2006 — 2006
American School in London
Carol Grigoletti Carol Grigoletti's Validant Consulting Experience December 2010 - May 2011
Job QMS Training Specialist at Medela, Inc.
Industry Medical Devices
Experience
Medela, Inc. May 2011 - Present
Validant Consulting December 2010 - May 2011
Baxter Healthcare Corporation February 2006 - February 2010
Welch Allyn (through Accord Consulting Services) February 2004 - February 2006
Baxter Healthcare Corporation January 2001 - August 2003
Baxter Healthcare Corporation January 1990 - January 2001
Baxter Healthcare Corporation April 1981 - August 1990
Skills
21 CFR Part 11, Validation, ISO 13485, Technical Writing, Auditing, Training Administration, Document Control, Document Management, Computer System..., Software Documentation, Quality Control, Quality System, Quality Management, 21 CFR, CAPA, Iso 9000, Quality Assurance, Quality Auditing, Cross-functional Team..., Root Cause Analysis, V&V, Medical Devices, FMEA, Process Improvement, GMP, Internal Audit, FDA, Regulatory Requirements, Change Control, Training, Regulatory Affairs, Calibration, Pharmaceutical Industry, ISO 14971, Design Control, Change Management, R&D, Regulatory Submissions, Sop, Flow Charts, Supplier Quality, FDA GMP
Education
Lake Forest Graduate School of Management 1991 — 1995
Exec. MBA, Business
Illinois State University 1970 — 1974
B.S. in Ed., Mathematics, English
Medela, Inc. May 2011 - Present
Validant Consulting December 2010 - May 2011
Baxter Healthcare Corporation February 2006 - February 2010
Welch Allyn (through Accord Consulting Services) February 2004 - February 2006
Baxter Healthcare Corporation January 2001 - August 2003
Baxter Healthcare Corporation January 1990 - January 2001
Baxter Healthcare Corporation April 1981 - August 1990
Skills
21 CFR Part 11, Validation, ISO 13485, Technical Writing, Auditing, Training Administration, Document Control, Document Management, Computer System..., Software Documentation, Quality Control, Quality System, Quality Management, 21 CFR, CAPA, Iso 9000, Quality Assurance, Quality Auditing, Cross-functional Team..., Root Cause Analysis, V&V, Medical Devices, FMEA, Process Improvement, GMP, Internal Audit, FDA, Regulatory Requirements, Change Control, Training, Regulatory Affairs, Calibration, Pharmaceutical Industry, ISO 14971, Design Control, Change Management, R&D, Regulatory Submissions, Sop, Flow Charts, Supplier Quality, FDA GMP
Education
Lake Forest Graduate School of Management 1991 — 1995
Exec. MBA, Business
Illinois State University 1970 — 1974
B.S. in Ed., Mathematics, English
Sandra Regnell Sandra Regnell's Validant Consulting Experience May 2014 - June 2015
Job Sr. Engineer
Industry Medical Devices
Experience
Amgen June 2015 - Present
Validant Consulting May 2014 - June 2015
Quallion July 2013 - May 2014
Baxter Healthcare August 2011 - July 2013
Oxford International July 2011 - August 2011
Contract Medical Device Manufacturing Company January 2011 - April 2011
Biosense Webster May 2009 - January 2011
BD Medical December 2008 - May 2009
Boston Scientific Neuromodulation August 2008 - November 2008
Advanced Bionics/Infusion Systems October 2007 - June 2008
Skills
FDA, V&V, Validation, Testing, Medical Devices, Design Control, Design of Experiments, Biomedical Engineering, R&D, Design for Manufacturing, FMEA, Product Launch, Root Cause Analysis, Minitab, Cross-functional Team..., Solidworks, AutoCAD, MRP, Catheters, Injection Molding, Manufacturing, GMP, ISO, Product Development, Commercialization, SPC, Six Sigma, Biomaterials, Process Engineering, ISO 14971, Quality System, Engineering Management, Continuous Improvement, ISO 13485, Sterilization, Manufacturing..., Quality Assurance, Machine Tools, Product Design, Engineering, FDA GMP, Quality Auditing, DMAIC, Quality Management, 21 CFR Part 11, Change Control, Process Simulation, Lean Manufacturing, SolidWorks
Education
Santa Clara University 1985 — 1990
BS, Mechanical Engineering
St. Stephens Episcopal School 1982 — 1985
High School, The Three R's
Amgen June 2015 - Present
Validant Consulting May 2014 - June 2015
Quallion July 2013 - May 2014
Baxter Healthcare August 2011 - July 2013
Oxford International July 2011 - August 2011
Contract Medical Device Manufacturing Company January 2011 - April 2011
Biosense Webster May 2009 - January 2011
BD Medical December 2008 - May 2009
Boston Scientific Neuromodulation August 2008 - November 2008
Advanced Bionics/Infusion Systems October 2007 - June 2008
Skills
FDA, V&V, Validation, Testing, Medical Devices, Design Control, Design of Experiments, Biomedical Engineering, R&D, Design for Manufacturing, FMEA, Product Launch, Root Cause Analysis, Minitab, Cross-functional Team..., Solidworks, AutoCAD, MRP, Catheters, Injection Molding, Manufacturing, GMP, ISO, Product Development, Commercialization, SPC, Six Sigma, Biomaterials, Process Engineering, ISO 14971, Quality System, Engineering Management, Continuous Improvement, ISO 13485, Sterilization, Manufacturing..., Quality Assurance, Machine Tools, Product Design, Engineering, FDA GMP, Quality Auditing, DMAIC, Quality Management, 21 CFR Part 11, Change Control, Process Simulation, Lean Manufacturing, SolidWorks
Education
Santa Clara University 1985 — 1990
BS, Mechanical Engineering
St. Stephens Episcopal School 1982 — 1985
High School, The Three R's
Colin Larsen's Validant Consulting Experience July 2008 - September 2012
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
Katherine Federico, Ed.D. Katherine Federico, Ed.D.'s Validant Consulting Experience 2006 - 2007
Job Account Manager
Industry Pharmaceuticals
Experience
Salix Pharmaceuticals September 2014 - Present
Lundbeck October 2013 - July 2014
Sunovion Pharmaceuticals Inc. August 2009 - March 2013
Alpharma (acquired by King) 2007 - 2008
Validant Consulting 2006 - 2007
Sepracor Pharmaceutical/SUNOVION March 2006 - September 2006
Janssen, Pharmaceutical Companies of Johnson and Johnson December 2001 - June 2005
Exchange Club Family Center 1998 - 2000
The Univeristy of Memphis & Christian Brothers Unviersity 1995 - 2000
Skills
Allergy, Gastroenterology, Neurology, Pulmonology, Rheumatology, Internal Medicine, Sales Effectiveness, Psychiatry, Neuroscience, Pain Management, Physiatry, Specialty Pharmaceutical, Treatment of depression, Bipolar Disorder, Schizophrenia, Alzheimer's disease, Personality Disorders, Counseling Psychology, Psychological Assessment, Multicultural Education, HIV, OB/GYN, Business Analysis, Team Leadership, Leadership Development, Cross-functional Team..., Employee Training, Compliance, University Teaching, Statistical Data..., Child Development, Early Childhood..., Child Advocacy, Sexual Violence, Criminal Law, Criminal Investigations, Managed Care, Selling Skills, Central Nervous System, Clinical Research, KOL development, Podiatry, Product Launch, Primary Care, Business Acumen, Infection, Pharmaceutical Industry, Healthcare, Hospitals, Pharmaceutical Sales
Education
The University of Memphis 1995 — 2000
Doctor of Education (Ed.D.), Mental Health Counseling/Counselor, 4.0
The University of Memphis 1993 — 1995
Master's degree, Clinical Psychology, 3.7
Christian Brothers University 1989 — 1993
Bachelor of Arts (B.A.), Psychology, 3.4
Salix Pharmaceuticals September 2014 - Present
Lundbeck October 2013 - July 2014
Sunovion Pharmaceuticals Inc. August 2009 - March 2013
Alpharma (acquired by King) 2007 - 2008
Validant Consulting 2006 - 2007
Sepracor Pharmaceutical/SUNOVION March 2006 - September 2006
Janssen, Pharmaceutical Companies of Johnson and Johnson December 2001 - June 2005
Exchange Club Family Center 1998 - 2000
The Univeristy of Memphis & Christian Brothers Unviersity 1995 - 2000
Skills
Allergy, Gastroenterology, Neurology, Pulmonology, Rheumatology, Internal Medicine, Sales Effectiveness, Psychiatry, Neuroscience, Pain Management, Physiatry, Specialty Pharmaceutical, Treatment of depression, Bipolar Disorder, Schizophrenia, Alzheimer's disease, Personality Disorders, Counseling Psychology, Psychological Assessment, Multicultural Education, HIV, OB/GYN, Business Analysis, Team Leadership, Leadership Development, Cross-functional Team..., Employee Training, Compliance, University Teaching, Statistical Data..., Child Development, Early Childhood..., Child Advocacy, Sexual Violence, Criminal Law, Criminal Investigations, Managed Care, Selling Skills, Central Nervous System, Clinical Research, KOL development, Podiatry, Product Launch, Primary Care, Business Acumen, Infection, Pharmaceutical Industry, Healthcare, Hospitals, Pharmaceutical Sales
Education
The University of Memphis 1995 — 2000
Doctor of Education (Ed.D.), Mental Health Counseling/Counselor, 4.0
The University of Memphis 1993 — 1995
Master's degree, Clinical Psychology, 3.7
Christian Brothers University 1989 — 1993
Bachelor of Arts (B.A.), Psychology, 3.4
Priscila Mota Priscila Mota's Validant Consulting Experience March 2009 - August 2009
Job Principal Post Market Surveillance Specialist at Fresenius Medical Care
Industry Medical Devices
Experience
Fresenius Medical Care January 2015 - Present
Philips May 2013 - January 2015
MAETRICS September 2012 - May 2013
Picis, a part of OptumInsight August 2011 - August 2012
Boston Scientific August 2009 - August 2011
Validant Consulting March 2009 - August 2009
Cordis, a Johnson and Johnson company May 2003 - July 2007
FPL 1998 - 2003
Skills
FDA, ISO 13485, Medical Devices, Quality System, CAPA, Quality Assurance, Complaint Management, Regulatory Affairs, GMP, Process Improvement, Quality Management, Cross-functional Team..., Sop, 21 CFR Part 11, Continuous Improvement, Iso 9000, Design Control, Risk Management, Root Cause Analysis, Regulatory Requirements, Training, ISO 14971, FMEA, Quality Auditing, ISO
Education
Miami Dade College
Associate of Arts (A.A.)
Fresenius Medical Care January 2015 - Present
Philips May 2013 - January 2015
MAETRICS September 2012 - May 2013
Picis, a part of OptumInsight August 2011 - August 2012
Boston Scientific August 2009 - August 2011
Validant Consulting March 2009 - August 2009
Cordis, a Johnson and Johnson company May 2003 - July 2007
FPL 1998 - 2003
Skills
FDA, ISO 13485, Medical Devices, Quality System, CAPA, Quality Assurance, Complaint Management, Regulatory Affairs, GMP, Process Improvement, Quality Management, Cross-functional Team..., Sop, 21 CFR Part 11, Continuous Improvement, Iso 9000, Design Control, Risk Management, Root Cause Analysis, Regulatory Requirements, Training, ISO 14971, FMEA, Quality Auditing, ISO
Education
Miami Dade College
Associate of Arts (A.A.)
Chuck Offutt Chuck Offutt's Validant Consulting Experience January 2011 - October 2012
Job Sr. Mgr Software Validation at Philips Healthcare
Industry Information Technology and Services
Experience
Philips Healthcare September 2012 - Present
Validant Consulting January 2011 - October 2012
Validant Strategic Consulting February 2010 - November 2011
Legato Consulting, llc December 2008 - February 2010
EnteGreat, Inc. 2001 - 2008
Stonebridge Technologies 2000 - 2001
TAVA Technologies March 1999 - March 2000
Raytheon 1991 - 2000
Rust International, Inc 1991 - 1998
Skills
Validation, MES, Customer Relations, Full SDLC, LIMS, Project Management, Process Improvement, Customer Service, Integration, Testing, Computer System..., FDA, GxP, Manufacturing, Software Quality..., Quality Assurance, Business Analysis, Management
Education
Arizona State University 1979 — 1981
MS, Electrical Engineering
Louisiana Tech University 1974 — 1979
BS, Biomedical Engineering
Philips Healthcare September 2012 - Present
Validant Consulting January 2011 - October 2012
Validant Strategic Consulting February 2010 - November 2011
Legato Consulting, llc December 2008 - February 2010
EnteGreat, Inc. 2001 - 2008
Stonebridge Technologies 2000 - 2001
TAVA Technologies March 1999 - March 2000
Raytheon 1991 - 2000
Rust International, Inc 1991 - 1998
Skills
Validation, MES, Customer Relations, Full SDLC, LIMS, Project Management, Process Improvement, Customer Service, Integration, Testing, Computer System..., FDA, GxP, Manufacturing, Software Quality..., Quality Assurance, Business Analysis, Management
Education
Arizona State University 1979 — 1981
MS, Electrical Engineering
Louisiana Tech University 1974 — 1979
BS, Biomedical Engineering
Doug Zisa's Validant Consulting Experience January 2013 - March 2013
Job Manager of Computer Systems Compliance at Arizona Nutritional Supplements
Industry Medical Devices
Experience
Arizona Nutritional Supplements January 2015 - Present
The Knollwood Group, LLC October 2011 - Present
Encode Inc. July 2013 - October 2013
Validant Consulting January 2013 - March 2013
Signature Consultants, LLC July 2012 - August 2012
West Pharmaceutical Services March 2006 - August 2011
PSC Biotech June 2005 - March 2006
Spherion Staffing Services March 2005 - June 2005
QPharma, Inc. June 2003 - December 2004
Phacor, Inc. February 2001 - May 2003
Skills
Quality Consulting, FDA Compliance, Quality Mgmt Systems, Auditing, ISO 9001, IS0 13485, ISO 19011, ISO 14971, 21 CFR, Part 820, 21 CFR, Part 11, Validation, CSV, SQA, Design Validation, Process Validation, Equipment Validation, Design Controls, Technical Writer, Document Control, CAPA, FMEA, VMP, IQ OQ PQ, SOX 404, 21 CFR Part 11, Document Management, Medical Devices, ISO 13485, Quality System, Change Control, Iso 9000, ISO, FDA, Quality Assurance, Validation Master Plans, V&V, Design Control, GxP, Software Documentation, SDLC, Computer System..., Quality Management, Testing, Pharmaceutical Industry
Education
University of San Francisco 1989 — 1990
BS, Organizational Behavior
Los Angeles City College
AS, Computer Technology
Arizona Nutritional Supplements January 2015 - Present
The Knollwood Group, LLC October 2011 - Present
Encode Inc. July 2013 - October 2013
Validant Consulting January 2013 - March 2013
Signature Consultants, LLC July 2012 - August 2012
West Pharmaceutical Services March 2006 - August 2011
PSC Biotech June 2005 - March 2006
Spherion Staffing Services March 2005 - June 2005
QPharma, Inc. June 2003 - December 2004
Phacor, Inc. February 2001 - May 2003
Skills
Quality Consulting, FDA Compliance, Quality Mgmt Systems, Auditing, ISO 9001, IS0 13485, ISO 19011, ISO 14971, 21 CFR, Part 820, 21 CFR, Part 11, Validation, CSV, SQA, Design Validation, Process Validation, Equipment Validation, Design Controls, Technical Writer, Document Control, CAPA, FMEA, VMP, IQ OQ PQ, SOX 404, 21 CFR Part 11, Document Management, Medical Devices, ISO 13485, Quality System, Change Control, Iso 9000, ISO, FDA, Quality Assurance, Validation Master Plans, V&V, Design Control, GxP, Software Documentation, SDLC, Computer System..., Quality Management, Testing, Pharmaceutical Industry
Education
University of San Francisco 1989 — 1990
BS, Organizational Behavior
Los Angeles City College
AS, Computer Technology
William Swigert William Swigert's Validant Consulting Experience February 2007 - October 2007
Job Pharmaceutical Production Supervisor
Industry Biotechnology
Experience
TOLMAR Inc. February 2015 - Present
Allergan April 2012 - March 2015
GlaxoSmithKline November 2007 - April 2012
validant Consulting February 2007 - October 2007
Insmed Therapeutic Proteins June 2004 - February 2007
Baxter May 2001 - November 2003
Baxter Hemoglobin Therapeutics May 2001 - October 2003
Skills
GMP, Validation, FDA, Purification, Fermentation, Sterilization, Biotechnology, Biopharmaceuticals, Root Cause Analysis, Technology Transfer, Sop, Aseptic Processing, Manufacturing, Change Control, V&V, Process Simulation, Vaccines, Formulation, Lyophilization, Fill, cGMP, FMEA, Process Validation, Chromatography, Aseptic Technique, Cleaning Validation, Deviations, Protein Purification, Filtration, Trackwise, ISO 13485, cGMP manufacturing, Lean Manufacturing, Lean Operations, Lean Management, 21 CFR Part 11, GLP, SOP
Education
University of Colorado 1996 — 2000
BA, Biochemistry & Molecular Biology
TOLMAR Inc. February 2015 - Present
Allergan April 2012 - March 2015
GlaxoSmithKline November 2007 - April 2012
validant Consulting February 2007 - October 2007
Insmed Therapeutic Proteins June 2004 - February 2007
Baxter May 2001 - November 2003
Baxter Hemoglobin Therapeutics May 2001 - October 2003
Skills
GMP, Validation, FDA, Purification, Fermentation, Sterilization, Biotechnology, Biopharmaceuticals, Root Cause Analysis, Technology Transfer, Sop, Aseptic Processing, Manufacturing, Change Control, V&V, Process Simulation, Vaccines, Formulation, Lyophilization, Fill, cGMP, FMEA, Process Validation, Chromatography, Aseptic Technique, Cleaning Validation, Deviations, Protein Purification, Filtration, Trackwise, ISO 13485, cGMP manufacturing, Lean Manufacturing, Lean Operations, Lean Management, 21 CFR Part 11, GLP, SOP
Education
University of Colorado 1996 — 2000
BA, Biochemistry & Molecular Biology
Tom East's Validant Consulting Experience February 2012 - August 2015
Job Consultant at Validant Consulting
Industry Pharmaceuticals
Experience
Validant Consulting February 2012 - August 2015
Tom East Consulting September 2008 - February 2012
MDRNA Inc January 2003 - August 2008
Sonus Pharmaceuticals January 1995 - January 2003
ProCyte June 1989 - October 1994
ALZA Corporation October 1978 - June 1989
Skills
Analytical Chemistry, Quality Control, Pharmaceutics, Start-ups, Biotechnology, Validation, GMP, Quality System, FDA, Regulatory Affairs, Pharmaceutical Industry, CAPA, Sop, GLP, Clinical Research, Regulatory Requirements, Vaccines, CMC, Medical Devices, Bioanalysis, Quality Assurance, Document Management, Biopharmaceuticals, Microbiology, Technology Transfer, Biochemistry, Clinical Development, Clinical Trials, R&D, Chemistry, NDA, Lifesciences, ISO 13485, Drug Delivery, GxP, 21 CFR Part 11, Aseptic Processing, Design of Experiments, Design Control, GCP, Gas Chromatography, HPLC, IND, ANDA, Regulatory Submissions, V&V, Oncology, GAMP, Quality Auditing, Toxicology
Education
California Polytechnic State University-San Luis Obispo 1969 — 1972
BS, Biochemistry
Validant Consulting February 2012 - August 2015
Tom East Consulting September 2008 - February 2012
MDRNA Inc January 2003 - August 2008
Sonus Pharmaceuticals January 1995 - January 2003
ProCyte June 1989 - October 1994
ALZA Corporation October 1978 - June 1989
Skills
Analytical Chemistry, Quality Control, Pharmaceutics, Start-ups, Biotechnology, Validation, GMP, Quality System, FDA, Regulatory Affairs, Pharmaceutical Industry, CAPA, Sop, GLP, Clinical Research, Regulatory Requirements, Vaccines, CMC, Medical Devices, Bioanalysis, Quality Assurance, Document Management, Biopharmaceuticals, Microbiology, Technology Transfer, Biochemistry, Clinical Development, Clinical Trials, R&D, Chemistry, NDA, Lifesciences, ISO 13485, Drug Delivery, GxP, 21 CFR Part 11, Aseptic Processing, Design of Experiments, Design Control, GCP, Gas Chromatography, HPLC, IND, ANDA, Regulatory Submissions, V&V, Oncology, GAMP, Quality Auditing, Toxicology
Education
California Polytechnic State University-San Luis Obispo 1969 — 1972
BS, Biochemistry
James Bentson James Bentson's Validant Consulting 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
mandy gervasio's Validant Consulting Experience January 2006 - January 2007
Job Quality Project Engineer Commercial Inhalation Expansion at Catalent Pharma Solutions
Industry Biotechnology
Experience
Catalent Pharma Solutions June 2014 - Present
VERTEX INC September 2011 - Present
Exemplar Pharmaceuticals/Laboratories, LLC August 2012 - December 2012
Genzyme October 2010 - August 2011
Genzyme March 2008 - 2011
WYETH BIOPHARMA January 2007 - March 2008
VALIDANT CONSULTING January 2006 - January 2007
XCELLEREX INC April 2005 - January 2006
Cambrex June 2004 - April 2005
ACAMBIS INC July 2002 - June 2004
Skills
GMP, Change Control, FDA, Sop, Validation, Biotechnology, CAPA, Quality System, 21 CFR Part 11, Trackwise, Pharmaceutical Industry, Aseptic Processing, Regulatory Affairs, Technology Transfer, GxP, Purification, Quality Control, Quality Assurance, Continuous Improvement, V&V, Manufacturing, Cross-functional Team..., Vaccines, Regulatory Requirements, SOP, TrackWise
Education
Northeastern University 2008 — 2010
Master of Science, Leadership; Project Management
University of Massachusetts 1997 — 2002
Bachelor of Science, Biology
Catalent Pharma Solutions June 2014 - Present
VERTEX INC September 2011 - Present
Exemplar Pharmaceuticals/Laboratories, LLC August 2012 - December 2012
Genzyme October 2010 - August 2011
Genzyme March 2008 - 2011
WYETH BIOPHARMA January 2007 - March 2008
VALIDANT CONSULTING January 2006 - January 2007
XCELLEREX INC April 2005 - January 2006
Cambrex June 2004 - April 2005
ACAMBIS INC July 2002 - June 2004
Skills
GMP, Change Control, FDA, Sop, Validation, Biotechnology, CAPA, Quality System, 21 CFR Part 11, Trackwise, Pharmaceutical Industry, Aseptic Processing, Regulatory Affairs, Technology Transfer, GxP, Purification, Quality Control, Quality Assurance, Continuous Improvement, V&V, Manufacturing, Cross-functional Team..., Vaccines, Regulatory Requirements, SOP, TrackWise
Education
Northeastern University 2008 — 2010
Master of Science, Leadership; Project Management
University of Massachusetts 1997 — 2002
Bachelor of Science, Biology
Chris (Changqing) Li Chris (Changqing) Li's Validant Consulting Experience 2007 - 2008
Job Owner and founder at Bovay Strategies
Industry Medical Devices
Experience
Micro-Tech USA May 2015 - Present
Bovay Strategies June 2013 - Present
Interplex Industries, Inc. April 2008 - May 2013
Boston Scientific February 2001 - April 2008
Validant Consulting 2007 - 2008
Sigma Aldrich November 1998 - February 2001
Skills
R&D, Medical Devices, Manufacturing, Product Development, Validation, Six Sigma, Quality Systems, Process Development, Product Management, Lean Manufacturing, Strategic Planning, ISO 13485, Life Sciences, cGMP, Process Improvement, Continuous Improvement, Engineering, Regulatory Affairs, Statistics, Quality Assurance, Program Management, Design of Experiments, Minitab, Matlab, Process Validation, Market Research, Product Launch, Data Analysis, Risk Management, Testing, Quality Management, Research, Problem Solving, Solidworks, SPC, Negotiation, Polymers, Business Strategy, DMAIC, Process Engineering, Intellectual Property, Team Building, Customer Relations, Characterization, MS Project, FDA, Quality System, GMP, V&V, FMEA
Education
Indiana University - Kelley School of Business 2002 — 2004
MBA, Business Administration and Management, General
The University of Akron 1995 — 1998
MS, Chemical Engineering
Tsinghua University 1990 — 1995
BS, Chemical Engineering
Micro-Tech USA May 2015 - Present
Bovay Strategies June 2013 - Present
Interplex Industries, Inc. April 2008 - May 2013
Boston Scientific February 2001 - April 2008
Validant Consulting 2007 - 2008
Sigma Aldrich November 1998 - February 2001
Skills
R&D, Medical Devices, Manufacturing, Product Development, Validation, Six Sigma, Quality Systems, Process Development, Product Management, Lean Manufacturing, Strategic Planning, ISO 13485, Life Sciences, cGMP, Process Improvement, Continuous Improvement, Engineering, Regulatory Affairs, Statistics, Quality Assurance, Program Management, Design of Experiments, Minitab, Matlab, Process Validation, Market Research, Product Launch, Data Analysis, Risk Management, Testing, Quality Management, Research, Problem Solving, Solidworks, SPC, Negotiation, Polymers, Business Strategy, DMAIC, Process Engineering, Intellectual Property, Team Building, Customer Relations, Characterization, MS Project, FDA, Quality System, GMP, V&V, FMEA
Education
Indiana University - Kelley School of Business 2002 — 2004
MBA, Business Administration and Management, General
The University of Akron 1995 — 1998
MS, Chemical Engineering
Tsinghua University 1990 — 1995
BS, Chemical Engineering
Kate Stoddard's Validant Consulting Experience October 2009 - December 2009
Job CoFounder | Owner at Das Bus
Industry Events Services
Experience
Das Bus February 2014 - Present
JMA Ventures January 2012 - February 2015
Swell Music March 2011 - January 2012
Crescendo! Studios March 2011 - January 2012
Flywheel Networks October 2010 - December 2010
Premier - Experts in Search and Placement May 2010 - October 2010
Validant Consulting October 2009 - December 2009
Hollman, Inc. September 2008 - August 2009
University of Colorado at Boulder August 2007 - August 2008
University of Colorado at Boulder August 2006 - September 2007
Skills
Photography, Facebook, Advertising, Marketing, Social Media, SEO, Editing, CRM, Market Research, Management, Social Media Marketing, Project Management, Online Advertising, Email Marketing, Sales
Education
University of Colorado Boulder 2004 — 2007
B.A., Psychology
California College of the Arts 2010 — 2010
Course in Communications Design
The Hockaday School
Das Bus February 2014 - Present
JMA Ventures January 2012 - February 2015
Swell Music March 2011 - January 2012
Crescendo! Studios March 2011 - January 2012
Flywheel Networks October 2010 - December 2010
Premier - Experts in Search and Placement May 2010 - October 2010
Validant Consulting October 2009 - December 2009
Hollman, Inc. September 2008 - August 2009
University of Colorado at Boulder August 2007 - August 2008
University of Colorado at Boulder August 2006 - September 2007
Skills
Photography, Facebook, Advertising, Marketing, Social Media, SEO, Editing, CRM, Market Research, Management, Social Media Marketing, Project Management, Online Advertising, Email Marketing, Sales
Education
University of Colorado Boulder 2004 — 2007
B.A., Psychology
California College of the Arts 2010 — 2010
Course in Communications Design
The Hockaday School
Theodore Hellen's Validant Consulting Experience 2008 - 2009
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
Russell Roberts's Validant Consulting Experience 2010 - 2011
Job RA/QA Compliance Specialist at Olympus
Industry Medical Devices
Experience
Olympus July 2014 - Present
Atrium Medical April 2013 - July 2014
Validant Consulting 2010 - 2011
Skills
Six Sigma, Cross-functional Team..., Process Improvement, Lean Manufacturing, Quality Assurance, Continuous Improvement, Quality Management, Validation, Product Launch, Quality Auditing, Pharmaceutical Industry, Product Development, Medical Devices, SPC, FMEA, Quality System, 5S, Process Simulation, Kaizen, FDA, CAPA, ISO, Root Cause Analysis, DMAIC, ISO 13485, Operational Excellence, Process Engineering, GMP, Minitab, V&V, Quality Control
Education
Albright College
Business/Managerial Economics
Oklahoma State University
Communication, Journalism, and Related Programs
Olympus July 2014 - Present
Atrium Medical April 2013 - July 2014
Validant Consulting 2010 - 2011
Skills
Six Sigma, Cross-functional Team..., Process Improvement, Lean Manufacturing, Quality Assurance, Continuous Improvement, Quality Management, Validation, Product Launch, Quality Auditing, Pharmaceutical Industry, Product Development, Medical Devices, SPC, FMEA, Quality System, 5S, Process Simulation, Kaizen, FDA, CAPA, ISO, Root Cause Analysis, DMAIC, ISO 13485, Operational Excellence, Process Engineering, GMP, Minitab, V&V, Quality Control
Education
Albright College
Business/Managerial Economics
Oklahoma State University
Communication, Journalism, and Related Programs
Heather Mitchell Heather Mitchell's Validant Consulting Experience 2011 - 2012
Job Online Marketing Specialist at RealPage, Inc.
Industry Marketing and Advertising
Experience
RealPage, Inc. January 2014 - Present
Indeed.com May 2013 - December 2013
Validant Consulting 2011 - 2012
Perfect Racquet 2006 - 2011
Mitchell Auto Group 2003 - 2006
Skills
Recruiting, Leadership, Sales, Account Management, Marketing, Management, Sourcing, Marketing Strategy, Social Media, Interviews, Time Management, Pharmaceutical Industry, Customer Satisfaction, Cold Calling, Customer Service, Sales Operations, Salesforce.com, Applicant Tracking..., GMP, CRM, Event Planning, Sop, Project Planning, Cross-functional Team..., Data Analysis, Process Improvement, Training, Public Relations, Market Research, Project Management, Strategy, Recruitment Advertising, Team Leadership, Lead Generation, Social Networking, Software Documentation, Business Development, Document Management, Competitive Analysis, Negotiation, Team Building, Online Marketing, SEM, SEO, Reporting & Analysis, Client Relations
Education
University of New Hampshire
BS, Business Administration concentration Management, Psychology minor
RealPage, Inc. January 2014 - Present
Indeed.com May 2013 - December 2013
Validant Consulting 2011 - 2012
Perfect Racquet 2006 - 2011
Mitchell Auto Group 2003 - 2006
Skills
Recruiting, Leadership, Sales, Account Management, Marketing, Management, Sourcing, Marketing Strategy, Social Media, Interviews, Time Management, Pharmaceutical Industry, Customer Satisfaction, Cold Calling, Customer Service, Sales Operations, Salesforce.com, Applicant Tracking..., GMP, CRM, Event Planning, Sop, Project Planning, Cross-functional Team..., Data Analysis, Process Improvement, Training, Public Relations, Market Research, Project Management, Strategy, Recruitment Advertising, Team Leadership, Lead Generation, Social Networking, Software Documentation, Business Development, Document Management, Competitive Analysis, Negotiation, Team Building, Online Marketing, SEM, SEO, Reporting & Analysis, Client Relations
Education
University of New Hampshire
BS, Business Administration concentration Management, Psychology minor
Chet Lis's Validant Consulting Experience November 2010 - April 2011
Job Mechanical or Industrial Engineering Professional
Industry Mechanical or Industrial Engineering
Experience
Self Senior Principal Quality and Sustaining EngineerMedela Healthcare, Inc.April 2011 - June 2013
Validant Consulting November 2010 - April 2011
Validant Consulting November 2007 - May 2008
Baxter Healthcare Corporation 2001 - 2007
Lucent Technologies 1991 - 2001
AT&T - Computer Systems Sourcing & Manufacturing 1986 - 1991
AT&T Teletype 1973 - 1986
AT&T Teletype 1970 - 1973
AT&T Teletype 1969 - 1970
AT&T Teletype 1962 - 1969
Skills
FDA, Quality Management, Quality Assurance, CAPA, Medical Devices, Manufacturing, Process Improvement, Continuous Improvement, Engineering Management, Product Development, R&D
Education
Northwestern University - Kellogg School of Management 1962 — 1966
Master of Business Administration (MBA), B+ Deans List for All Semesters
Illinois Institute of Technology 1958 — 1962
Bachelor of Science (BS), Mechanical Engineering, B+ Was on Scholastic Scholarship for 4 years
Holy Trinity High School
Self Senior Principal Quality and Sustaining EngineerMedela Healthcare, Inc.April 2011 - June 2013
Validant Consulting November 2010 - April 2011
Validant Consulting November 2007 - May 2008
Baxter Healthcare Corporation 2001 - 2007
Lucent Technologies 1991 - 2001
AT&T - Computer Systems Sourcing & Manufacturing 1986 - 1991
AT&T Teletype 1973 - 1986
AT&T Teletype 1970 - 1973
AT&T Teletype 1969 - 1970
AT&T Teletype 1962 - 1969
Skills
FDA, Quality Management, Quality Assurance, CAPA, Medical Devices, Manufacturing, Process Improvement, Continuous Improvement, Engineering Management, Product Development, R&D
Education
Northwestern University - Kellogg School of Management 1962 — 1966
Master of Business Administration (MBA), B+ Deans List for All Semesters
Illinois Institute of Technology 1958 — 1962
Bachelor of Science (BS), Mechanical Engineering, B+ Was on Scholastic Scholarship for 4 years
Holy Trinity High School
Latha Narayanan's Validant Consulting Experience October 2014 - December 2014
Job at
Industry Pharmaceuticals
Experience
Relypsa March 2015 - September 2015
Validant Consulting October 2014 - December 2014
Gilead Sciences June 2004 - March 2014
Alza Corporation/JnJ May 2000 - December 2003
Skills
GLP, GMP, Sop, Validation, FDA, Biotechnology, Management, HPLC, CAPA, LIMS, Pharmaceutical Industry, Regulatory Submissions, Dissolution, SOP, Assay Development, Quality Control, Cross-functional Team..., IND, Laboratory
Education
Golden Gate University 2008 — 2010
Master of Business Administration (MBA)
University of Calicut 1975 — 1979
BS
Relypsa March 2015 - September 2015
Validant Consulting October 2014 - December 2014
Gilead Sciences June 2004 - March 2014
Alza Corporation/JnJ May 2000 - December 2003
Skills
GLP, GMP, Sop, Validation, FDA, Biotechnology, Management, HPLC, CAPA, LIMS, Pharmaceutical Industry, Regulatory Submissions, Dissolution, SOP, Assay Development, Quality Control, Cross-functional Team..., IND, Laboratory
Education
Golden Gate University 2008 — 2010
Master of Business Administration (MBA)
University of Calicut 1975 — 1979
BS
Nicholas Tabrizi's Validant Consulting Experience February 2009 - April 2010
Job Principal Regulatory Affairs Specialist at Medtronic Spine & Biologics
Industry Medical Devices
Experience
Medtronic Spine & Biologics March 2013 - Present
Medtronic April 2010 - Present
Validant Consulting February 2009 - April 2010
Smith & Nephew Orthopaedics January 2007 - January 2009
Smith & Nephew Orthopaedics December 2005 - January 2007
Skills
PMA, 21 CFR, ISO 14971, ISO 13485, Medical Devices, V&V, Design Control, FDA, Validation, Regulatory Affairs, CAPA
Education
Christian Brothers University 2009 — 2013
Masters of Science, Engineering Management
The University of Memphis 2001 — 2005
Bachelor of Science (B.S.), Mechanical Engineering
Medtronic Spine & Biologics March 2013 - Present
Medtronic April 2010 - Present
Validant Consulting February 2009 - April 2010
Smith & Nephew Orthopaedics January 2007 - January 2009
Smith & Nephew Orthopaedics December 2005 - January 2007
Skills
PMA, 21 CFR, ISO 14971, ISO 13485, Medical Devices, V&V, Design Control, FDA, Validation, Regulatory Affairs, CAPA
Education
Christian Brothers University 2009 — 2013
Masters of Science, Engineering Management
The University of Memphis 2001 — 2005
Bachelor of Science (B.S.), Mechanical Engineering
Johnny Long's Validant Consulting Experience May 2008 - February 2011
Job Corporate Vice President at Validant
Industry Management Consulting
Experience
Validant September 2013 - Present
Validant March 2012 - August 2013
Validant February 2011 - March 2012
Validant Consulting May 2008 - February 2011
Validant Consultling April 2005 - April 2008
Baxter 1987 - 2004
Baxter Healthcare 1975 - 2004
Skills
Quality Systems, Quality Auditing, Process Validation, cGMP, Validation, Quality Engineering, Quality Management, Compliance, Remediation, CAPA, V&V, 21 CFR Part 11, ISO, GMP, Sop, Medical Devices, Pharmaceutical Industry, Quality System, Continuous Improvement, Manufacturing, Operational Excellence, R&D, Quality Control, Leadership, Quality Assurance, Lean Manufacturing, GLP, Pharmaceutics, Six Sigma, Biotechnology, Root Cause Analysis, Technology Transfer, Cross-functional Team..., Document Management, Regulatory Affairs, Iso 9000, Biopharmaceuticals, Regulatory Submissions, Regulatory Requirements, Lifesciences, Design Control, Process Simulation, Computer System..., Design of Experiments, GCP, Software Documentation, FMEA, DMAIC, SPC, Management
Education
Appalachian State University
Master's degree, Business Administration and Management, General
University of North Carolina at Chapel Hill
Bachelor of Science (BS), Chemistry
Validant September 2013 - Present
Validant March 2012 - August 2013
Validant February 2011 - March 2012
Validant Consulting May 2008 - February 2011
Validant Consultling April 2005 - April 2008
Baxter 1987 - 2004
Baxter Healthcare 1975 - 2004
Skills
Quality Systems, Quality Auditing, Process Validation, cGMP, Validation, Quality Engineering, Quality Management, Compliance, Remediation, CAPA, V&V, 21 CFR Part 11, ISO, GMP, Sop, Medical Devices, Pharmaceutical Industry, Quality System, Continuous Improvement, Manufacturing, Operational Excellence, R&D, Quality Control, Leadership, Quality Assurance, Lean Manufacturing, GLP, Pharmaceutics, Six Sigma, Biotechnology, Root Cause Analysis, Technology Transfer, Cross-functional Team..., Document Management, Regulatory Affairs, Iso 9000, Biopharmaceuticals, Regulatory Submissions, Regulatory Requirements, Lifesciences, Design Control, Process Simulation, Computer System..., Design of Experiments, GCP, Software Documentation, FMEA, DMAIC, SPC, Management
Education
Appalachian State University
Master's degree, Business Administration and Management, General
University of North Carolina at Chapel Hill
Bachelor of Science (BS), Chemistry
Dietmar Mossem's Validant Consulting Experience May 2012 - September 2012
Job QC/QA Chemist, GMP/QA Compliance and Validation
Industry Pharmaceuticals
Experience
Mossem Magnetic Res. LLC September 2012 - Present
Pfizer November 2012 - April 2013
Validant Consulting May 2012 - September 2012
Ambiopharm, Inc. April 2008 - January 2009
Chrysalis Technologies March 2007 - April 2008
Wyeth August 2006 - January 2007
PPD September 2005 - May 2006
Aderis Pharmaceuticals, Inc. June 1989 - May 2005
Skills
Pharmaceutical Industry, Microsoft Office, Microsoft Excel, Project Management, Strategic Planning, GMP, Biotechnology, Clinical Trials, PowerPoint, Clinical Research, Microsoft Word, Pharmaceutical Sales, Oncology, Validation, Marketing Strategy, Change Management, Customer Service, Sales Management, Negotiation, Lifesciences, Medical Devices, FDA, Quality Assurance, Data Analysis, SOP, Quality Control
Education
Averett University 2009 — 2011
MBA, Business Administration, Management and Operations
UCSB 1983 — 1986
Bachelor's degree, Pharmacology
Mossem Magnetic Res. LLC September 2012 - Present
Pfizer November 2012 - April 2013
Validant Consulting May 2012 - September 2012
Ambiopharm, Inc. April 2008 - January 2009
Chrysalis Technologies March 2007 - April 2008
Wyeth August 2006 - January 2007
PPD September 2005 - May 2006
Aderis Pharmaceuticals, Inc. June 1989 - May 2005
Skills
Pharmaceutical Industry, Microsoft Office, Microsoft Excel, Project Management, Strategic Planning, GMP, Biotechnology, Clinical Trials, PowerPoint, Clinical Research, Microsoft Word, Pharmaceutical Sales, Oncology, Validation, Marketing Strategy, Change Management, Customer Service, Sales Management, Negotiation, Lifesciences, Medical Devices, FDA, Quality Assurance, Data Analysis, SOP, Quality Control
Education
Averett University 2009 — 2011
MBA, Business Administration, Management and Operations
UCSB 1983 — 1986
Bachelor's degree, Pharmacology
Andrew (Andy) Dille, PE, MSME's Validant Consulting Experience August 2009 - December 2009
Job Mechanical or Industrial Engineering Professional
Industry Mechanical or Industrial Engineering
Experience
Medical Devices, Mechanical Engineering, Manufacturing Companies January 2010 - Present
Synovis Surgical Innovations 2011 - 2011
Validant Consulting August 2009 - December 2009
Emerson Process Management January 2005 - August 2008
Minntech Corporation June 1996 - August 2003
Johnson and Johnson January 1994 - May 1996
Skills
Process Engineering, Engineering, Manufacturing, Mechanical Engineering, Medical Devices, Validation, Testing, Product Development, FDA, Design of Experiments, Injection Molding
Education
Leibniz Universität Hannover 1980 — 1985
( MSME) Diplom-Ingenieur, Mechanical Engineering
Litchfield
University of Minnesota-Twin Cities
BSME, Mechanical Engineering
Medical Devices, Mechanical Engineering, Manufacturing Companies January 2010 - Present
Synovis Surgical Innovations 2011 - 2011
Validant Consulting August 2009 - December 2009
Emerson Process Management January 2005 - August 2008
Minntech Corporation June 1996 - August 2003
Johnson and Johnson January 1994 - May 1996
Skills
Process Engineering, Engineering, Manufacturing, Mechanical Engineering, Medical Devices, Validation, Testing, Product Development, FDA, Design of Experiments, Injection Molding
Education
Leibniz Universität Hannover 1980 — 1985
( MSME) Diplom-Ingenieur, Mechanical Engineering
Litchfield
University of Minnesota-Twin Cities
BSME, Mechanical Engineering
Rod Wein's Validant Consulting Experience 2009 - 2009
Job Medical Devices Professional
Industry Medical Devices
Experience
Validant Consulting 2009 - 2009
Baxter Healthcare Corporation 1978 - 1994
Skills
Medical Devices, CAPA, FDA, Design Control, Talent Acquisition, Pharmaceutical Industry, Cross-functional Team..., Quality System, Quality Assurance, R&D, ISO 13485, Process Improvement, Leadership, Management
Education
University of California, Los Angeles
Bachelor of Science (BSc), Computer Science
Validant Consulting 2009 - 2009
Baxter Healthcare Corporation 1978 - 1994
Skills
Medical Devices, CAPA, FDA, Design Control, Talent Acquisition, Pharmaceutical Industry, Cross-functional Team..., Quality System, Quality Assurance, R&D, ISO 13485, Process Improvement, Leadership, Management
Education
University of California, Los Angeles
Bachelor of Science (BSc), Computer Science
Brian Gard's Validant Consulting Experience 2009 - 2009
Job Compliance and Quality Consultant at Maetrics, LLC
Industry Medical Devices
Experience
Maetrics, LLC May 2013 - Present
Cummins Inc. August 2011 - May 2013
Various Medical Device Companies 2008 - September 2011
Performance Driven LLC 2006 - 2011
Greatbatch, Inc. 2010 - 2010
Real Images December 2009 - 2010
Validant Consulting 2009 - 2009
Batesville Casket Company 2005 - 2008
Hill-Rom 2001 - 2004
Cummins, Inc 1999 - 2001
Skills
Six Sigma, FDA GMP, Validation, CAPA, Remediation, Quality Management, 21 CFR Part 11, CFR, Black Belt, Corrective Actions, Program Management, ISO 13485, New Product Validation, Supplier Quality, Lean Manufacturing, Quality System, Automotive, Medical Devices, Project Management, Quality Assurance, Quality Control, Continuous Improvement, Cross-functional Team..., Product Development
Education
Xavier University 2006 — 2006
Six Sigma Black Belt
Indiana State University 1989 — 1994
BS, EET
Maetrics, LLC May 2013 - Present
Cummins Inc. August 2011 - May 2013
Various Medical Device Companies 2008 - September 2011
Performance Driven LLC 2006 - 2011
Greatbatch, Inc. 2010 - 2010
Real Images December 2009 - 2010
Validant Consulting 2009 - 2009
Batesville Casket Company 2005 - 2008
Hill-Rom 2001 - 2004
Cummins, Inc 1999 - 2001
Skills
Six Sigma, FDA GMP, Validation, CAPA, Remediation, Quality Management, 21 CFR Part 11, CFR, Black Belt, Corrective Actions, Program Management, ISO 13485, New Product Validation, Supplier Quality, Lean Manufacturing, Quality System, Automotive, Medical Devices, Project Management, Quality Assurance, Quality Control, Continuous Improvement, Cross-functional Team..., Product Development
Education
Xavier University 2006 — 2006
Six Sigma Black Belt
Indiana State University 1989 — 1994
BS, EET
Mabel Fombu's Validant Consulting Experience Senior Quality ConsultantValidant2009 - Present
Job Quality Consulltant at Validant Consulting
Industry Medical Devices
Experience
Validant Consulting Senior Quality ConsultantValidant2009 - Present
Boston Scientific Maple Grove 2009 - 2010
Cordis August 2006 - May 2008
Skills
Complaint Management, FDA, Quality System, 21 CFR Part 11, Regulatory Affairs, CAPA, Sop, ISO 13485, Medical Devices, GMP, ISO 14971, Biotechnology, V&V, Quality Assurance, Pharmaceutical Industry, Software Documentation, Design Control, Validation, Regulatory Submissions, Quality Management, ISO, GCP, Lifesciences, Process Improvement
Education
Duke University 2012 — 2014
Master's Degree, Nursing/Clinical Research Management
Florida International University 2003 — 2005
BS, Political science and Philosophy
University of Miami 1988 — 2000
BSN, Nursing
Validant Consulting Senior Quality ConsultantValidant2009 - Present
Boston Scientific Maple Grove 2009 - 2010
Cordis August 2006 - May 2008
Skills
Complaint Management, FDA, Quality System, 21 CFR Part 11, Regulatory Affairs, CAPA, Sop, ISO 13485, Medical Devices, GMP, ISO 14971, Biotechnology, V&V, Quality Assurance, Pharmaceutical Industry, Software Documentation, Design Control, Validation, Regulatory Submissions, Quality Management, ISO, GCP, Lifesciences, Process Improvement
Education
Duke University 2012 — 2014
Master's Degree, Nursing/Clinical Research Management
Florida International University 2003 — 2005
BS, Political science and Philosophy
University of Miami 1988 — 2000
BSN, Nursing
Richard Stonehouse's Validant Consulting Experience November 2012 - Present
Job Quality Assurance Specialist at Validant Consulting
Industry Medical Devices
Experience
Validant Consulting November 2012 - Present
Independent Contractor November 2011 - April 2012
Independent Contractor June 1993 - April 2010
Skills
ISO 13485, Quality System, CAPA, Quality Auditing, Quality Assurance, FDA, GMP, Iso 9000, Lean Manufacturing, Supplier Quality, Medical Devices, ISO 14001, AS9100, TS16949, Engineering, ISO 17025, Auditing, GLP, 21 CFR, Failure Analysis, Corrective Actions, Program Management
Education
Northeastern University 1978 — 1982
BSME, Mechanical Engineering
Validant Consulting November 2012 - Present
Independent Contractor November 2011 - April 2012
Independent Contractor June 1993 - April 2010
Skills
ISO 13485, Quality System, CAPA, Quality Auditing, Quality Assurance, FDA, GMP, Iso 9000, Lean Manufacturing, Supplier Quality, Medical Devices, ISO 14001, AS9100, TS16949, Engineering, ISO 17025, Auditing, GLP, 21 CFR, Failure Analysis, Corrective Actions, Program Management
Education
Northeastern University 1978 — 1982
BSME, Mechanical Engineering
Kathy Dejneka's Validant Consulting Experience November 2010 - January 2011
Job Senior Quality Engineer at Accellent
Industry Medical Devices
Experience
Accellent 2012 - Present
Teleflex Medical February 2011 - August 2012
Validant Consulting November 2010 - January 2011
St. Jude Medical July 2007 - July 2010
EPMedSystems September 2004 - July 2007
Integra LifeSciences 1999 - 2002
B Braun Medical 1990 - 1999
Skills
Design Control, ISO 14971, ISO 13485, Medical Devices, CAPA, Quality System, FDA, V&V, Supplier Quality, 21 CFR Part 11, GMP, Biomedical Engineering, Design of Experiments, Quality Assurance, Minitab, CE marking, Validation, DMAIC, FMEA, Manufacturing, Change Control, 21 CFR, Design for Manufacturing, R&D, Product Development, Root Cause Analysis, ISO, Regulatory Submissions, Quality Auditing, Catheters, SPC, Regulatory Affairs, FDA GMP, Quality Management, Quality Control
Education
Rutgers University-New Brunswick
Accellent 2012 - Present
Teleflex Medical February 2011 - August 2012
Validant Consulting November 2010 - January 2011
St. Jude Medical July 2007 - July 2010
EPMedSystems September 2004 - July 2007
Integra LifeSciences 1999 - 2002
B Braun Medical 1990 - 1999
Skills
Design Control, ISO 14971, ISO 13485, Medical Devices, CAPA, Quality System, FDA, V&V, Supplier Quality, 21 CFR Part 11, GMP, Biomedical Engineering, Design of Experiments, Quality Assurance, Minitab, CE marking, Validation, DMAIC, FMEA, Manufacturing, Change Control, 21 CFR, Design for Manufacturing, R&D, Product Development, Root Cause Analysis, ISO, Regulatory Submissions, Quality Auditing, Catheters, SPC, Regulatory Affairs, FDA GMP, Quality Management, Quality Control
Education
Rutgers University-New Brunswick