Validant Company
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Validant Employees
Accriva Diagnostics May 2015 - Present
Irvine Pharmaceutical Services October 2014 - May 2015
Validant May 2012 - September 2014
Abbott Vascular April 2006 - January 2012
Pfizer January 2000 - April 2006
Pfizer April 1997 - January 2000
Gilead Sciences January 1992 - April 1997
Skills
GMP, CAPA, FDA, Validation, Quality System, Quality Control, LIMS, Process Improvement, GLP, Cross-functional Team..., Management, Product Development, Six Sigma
Education
University of Phoenix
Master of Business Administration (M.B.A.), Business Administration and Management, General
Alexandria University
Bachelor's Degree, Double major in Chemistry and Botany, Top five
Validant July 2014 - Present
Sandoz April 2007 - May 2014
Sandoz April 2007 - October 2010
Columbia Analytical Services March 2006 - February 2007
Green Analytical Chemistry Inc May 2005 - March 2006
Skills
Competent in Current..., HPLC, Analytical Method..., Dissolution, Process Validation, Analytical Chemistry, GMP, LIMS, GLP, Titration, Chromatography, USP, V&V, UV, UV/Vis, Sop, Validation, SOP, Pharmaceutical Industry, FDA, 21 CFR Part 11
Education
Fort Lewis College 1999 — 2004
Bachelor of Science (B.S.), Chemistry
Collins Consulting Group July 2014 - Present
Bioserv Corporation February 2013 - Present
Validant April 2012 - February 2013
SAFC Pharma Carlsbad November 2000 - April 2012
Chiron/Viagene 1996 - 2000
Skills
Technology Transfer, Biotechnology, GMP, FDA, Validation, Sop, Lifesciences, Pharmaceutical Industry, CAPA, Regulatory Affairs, Quality System, HPLC, V&V, GLP, Medical Devices, 21 CFR Part 11, Aseptic Processing, Biologics, Biopharmaceuticals, Calibration, Change Control, Cleaning Validation, Clinical Trials, Contract Manufacturing, GCP, GxP, IND, ISO, ISO 13485, Laboratory, Life Sciences, Manufacturing, Microbiology, Pharmaceutics, Quality Assurance, Quality Auditing, Quality Control, Quality Management, R, Regulatory Requirements, SOP, Sterilization, Supplier Quality, Vaccines
Education
Rhode Island College 1992 — 1993
MS, Instructional Technology
Long Island University, Southampton Campus 1986 — 1990
BS, Biology
Validant April 2014 - May 2015
ProPharma Group June 2013 - February 2014
Tolmar Inc. September 2011 - March 2013
Oso BioPharmaceuticals Manufacturing, LLC January 2009 - December 2010
Talecris Biotherapeutics, Inc. August 2000 - May 2007
Skills
Project Management, Statistical Data..., Technical Writing, Compliance management, Training program design, Operational..., Regulatory Agency Audits, Hiring top talent, Agilent Chemstation..., ROI analyses, Smartsolve and..., SQL based LIMS systems, Supervising and..., cGMP in Analytical..., Managing laboratory..., Operational SOP..., Team-building, HPLC methods, CAPA design, QC and MFG Partnerships, Microsoft Office and..., Equipment qualification..., Root Cause Analysis, Deviation report writing, Quality Systems, Parenteral, Solid-Dose,..., Quality System, Talent Management, Training, GMP, LIMS, Quality Control, HPLC, Pharmaceutical Industry, Chemistry, Software Documentation, Team Building, Quality Assurance, Laboratory, FDA, CAPA, Validation, SOP
Education
North Carolina State University - College of Management 2006 — 2012
MBA, Management and Finance
Wofford College 1981 — 1985
B.S., Chemistry
David W. Pennington, LLC November 2013 - Present
Novartis Consumer Health February 2012 - April 2013
Validant February 2012 - April 2013
Automated Systems, Inc. March 2003 - February 2012
Phillips-Medisize October 2011 - January 2012
Promega 2010 - August 2011
Catalent Pharma Solutions 2005 - 2011
Abbott Laboratories 2003 - 2009
Illinois School District 114 1995 - 2007
Baxter Healthcare Corporation 1990 - 2002
Skills
Validation, FDA, CAPA, GMP, Medical Devices, Change Control, 21 CFR Part 11, Pharmaceutical Industry, Quality System, Sop, Technology Transfer, Biotechnology, ISO 13485, Computer System..., ISO 14971, Cross-functional Team..., Product Development, R&D, Regulatory Requirements, Manufacturing, GAMP, GxP, Regulatory Affairs, Six Sigma, Quality Control, Testing, Software Documentation, Design Control, ISO, Quality Management, Calibration, GLP, Laboratory, SOP development, FMEA, Automation, Document Management, Root Cause Analysis
Education
University of Missouri-Kansas City 1976 — 1980
BS, Mechanical Engineering
Carleton College 1967 — 1971
BA, Philosophy
University of Missouri-Rolla
The City of Calgary November 2014 - Present
SourceDogg April 2013 - September 2014
SourceDogg April 2013 - July 2013
Validant May 2012 - January 2013
Toys4you Stores and Website July 2011 - February 2012
CIBC June 2010 - September 2010
BEF Property, Galway, Ireland and Nice, France. 2002 - 2009
Skills
Supply Chain Management, Management, Business Strategy, Strategy, Business Systems..., Analysis, Digital Marketing, New Business Development, PowerPoint, Microsoft Excel, Business Development, Finance, Marketing, Business Analysis, Corporate Finance, Microsoft Word, Market Research, International Business..., Marketing Strategy, Intercultural..., Business Communications, Word, Website Development, Cygwin, SQL Server Management..., Scrum Master, SSIS, TFS, Data Modeling, SEM, SEO, SDLC, Sprint Planning, jQuery, CSS, Bootstrap, HTML, Quality Assurance, Bug Tracking, Logistics, Procurement, Government Procurement, E-procurement, EPC, SAP ERP, Project Management
Education
National University of Ireland, Galway 2010 — 2011
Master of Science (M.Sc.), International Management, 2.1 2nd class honors grade 1
Galway-Mayo Institute of Technology 2008 — 2009
Bachelor's degree, Business Studies and Marketing, 2.1 2nd class honors grade 1
Ipag Business School 2007 — 2008
Advanced Diploma, International Business, 2.1 2nd class honors grade 1
Academy of Financial Trading 2013 — 2013
Financial Trading Programme
New York Institute of Finance 2012 — 2012
Fixed Income Markets, 3.6
Yeats College 2002 — 2003
Leaving Certificate
Validant March 2012 - October 2013
Merck May 2010 - December 2011
Pfizer August 2007 - May 2010
Wyeth April 2006 - August 2007
Wyeth July 2004 - March 2006
Skills
CAPA, 21 CFR Part 11, FDA, Change Control, GMP, Computer System..., Quality System, Sop, Pharmaceutical Industry, Quality Assurance, Regulatory Affairs, Biotechnology, Quality Control, LIMS, Software Documentation
Education
Iona College
Master of Business Administration (MBA)
Kean University
Bachelor of Applied Science (B.A.Sc.), Biotechnology
HealthSTAR Communications August 2014 - Present
Validant August 2013 - Present
Affymax May 2012 - April 2013
Skills
Biotechnology, Dialysis, FDA, Medical Devices, Nephrology, Pharmaceutical Industry, Clinical Research, Clinical Development, Clinical Trials, GCP, Healthcare, Diabetes, Medical Affairs, Pharmaceutical Sales, Healthcare Management, Nursing, Cardiology
Education
Bellevue University 2001 — 2003
Master of Business Administration (MBA), Health/Health Care Administration/Management
University of North Carolina at Wilmington 1992 — 1996
Bachelor of Science (BS), Registered Nursing/Registered Nurse
Medtronic Spine & Biologics January 2015 - Present
Medtronic Spine & Biologics September 2013 - Present
Eliassen Group November 2012 - September 2013
Christie Medical Holdings, Inc. February 2011 - November 2012
NWCC January 2011 - May 2011
Validant November 2009 - February 2011
Medtronic February 2007 - November 2009
Kelly Scientific Resources September 2003 - February 2007
Baxter Healthcare 2002 - 2003
Skills
Medical Devices, Biotechnology, Life Sciences, Clinical, FDA, Recruiting, Quality Investigations
Education
Delta State University (NG) 2002 — 2003
M.S.N.S., Chemistry
Delta State University 1999 — 2002
B.S., Chemistry
Calgaz, a division of Air Liquide October 2014 - Present
Consulting Services February 2006 - October 2014
Validant March 2012 - February 2014
First Quality January 2011 - October 2011
ZeroChaos April 2008 - December 2008
Fluor February 2006 - November 2007
Merck December 1996 - February 2006
US Army 1981 - 1991
Skills
Pharmaceutical Industry, FDA, Quality Assurance, GMP, Quality System, Process Improvement, Training, Continuous Improvement, Biotechnology, Sop, Cross-functional Team..., Regulatory Requirements, Consent Decree, Compliance Remediation, FDA GMP, American Society for..., Workforce Education, Corporate Training, TESOL, Accent Reduction, 21 CFR Part 11, Manufacturing, Change Control, Gap Analysis, Quality Auditing, Document Management, Documentum, Technical Writing, Lifesciences, Technical Training, Employee Training, Training Delivery, Onboarding, ADDIE, Instructor-led Training, Instructional Design, Aseptic Processing, Regulatory Affairs, GxP, SOP, Life Sciences
Education
Barton College 1992 — 1996
BS & BA, Business Management & Hispanic Studies/Spanish, 4.0/3.9
American InterContinental University
Master of Education (M.Ed.), Curriculum and Instruction (50% complete)
Validant August 2013 - Present
Fleischman Field Research February 2013 - August 2013
UCI Children's Center April 2012 - June 2012
UCI Child Development Center September 2011 - June 2012
COPE Health Solutions January 2011 - October 2011
UCI Academic Testing Center June 2011 - September 2011
United Way of the Bay Area June 2007 - August 2007
Education
University of California, Irvine 2008 — 2012
Bachelor of Science, Public Health Sciences
City College of San Francisco
Abraham Lincoln High School 2004 — 2008
Diploma
Redapt, Inc. February 2015 - Present
Validant November 2011 - January 2015
Extended Day Child Care June 2009 - November 2011
Pleasanton Unified School District December 2009 - September 2011
Abercrombie & Fitch January 2005 - June 2009
Skills
Project Management, Validation, Biotechnology, Quality System, FDA, Medical Devices, Leadership, Cross-functional Team..., Regulatory Affairs, Quality Auditing, Technical Recruiting, ISO, Manufacturing, 21 CFR Part 11, Six Sigma, ISO 13485, R&D, V&V, CAPA, Quality Assurance, Lean Manufacturing, Process Engineering, Clinical Trials, SPC, Consulting, Continuous Improvement, Design of Experiments, Pharmaceutical Industry, Pharmaceutics, Change Control, GMP, Quality Control, GLP, Sop, Minitab, Quality Management, Lifesciences, Product Launch, Process Improvement, Root Cause Analysis, Process Simulation, Software Documentation, Auditing, Product Development
Education
California State University-Chico 2005 — 2009
Bachelor's Degree, Psychology
California State University-Chico 2005 — 2009
Bachelor's Degree, Child Development
NAMSA February 2015 - Present
NAMSA August 2013 - February 2015
Validant April 2013 - May 2013
Teva Pharmaceuticals August 2010 - October 2012
Teva Pharmaceuticals March 2006 - August 2010
Teva Pharmaceuticals August 2005 - March 2006
On Assignment July 2004 - February 2005
On Assignment November 2003 - July 2004
Handee Hugo's 1999 - 2003
Skills
Microbiology, Laboratory, Quality Control, GLP, Biotechnology, GMP, Pharmaceutical Industry, Lifesciences, ELISA, Clean Room..., PCR, real-time PCR, LC/MS/MS, cGMP practices, cGMP manufacturing, FDA GMP, Iso 9000, Sop, 21 CFR Part 11, Public Health, CAPA, Biopharmaceuticals, UV/Vis, Validation, DNA extraction, LIMS, Aseptic Processing, Environmental Monitoring, Deviations, Quality Assurance, Quality System
Education
Walden University 2010 — 2013
Master of Public Health (M.P.H.), Public Health
North Carolina State University 2001 — 2003
BSc, Microbiology
Validant 2013 - Present
Validant 2013 - May 2014
Validant 2013 - October 2013
American Indian Model Schools September 2012 - 2013
American Indian Public Charter School I June 2012 - 2013
American Indian Public Charter School II 2010 - 2012
Skills
Research, Management, Training, Data Analysis, Analysis, Microsoft Office, Recruiting, Public Speaking, Teaching, Leadership, Event Planning, Curriculum Design, Microsoft Excel, PowerPoint, Social Media, Microsoft Word, Customer Service, Editing, Strategic Planning, Pharmaceutical Industry, FDA, Biotechnology, Curriculum Development, Leadership Development, Educational Leadership, Community Outreach, Nonprofits, Social Networking, Lesson Planning, Educational Technology, Public Relations, Classroom, Teacher Training, Team Leadership, Classroom Management, Facebook, Differentiated..., Literacy, Python
Education
University of California, Berkeley
Bachelor of Arts, Economics
Alliant International University-San Francisco Bay
California Multiple Subjects Teaching Credential, Education
University of Michigan 2015 — 2015
Coursera/10-Week MOOC, Python
ETAS November 2014 - Present
Aerotech, Inc. April 2014 - November 2014
Maetrics, LLC September 2013 - March 2014
Validant April 2011 - July 2013
Baxter International Inc. August 2006 - March 2011
Intel Corporation January 2001 - August 2006
Be Free, Inc January 2000 - July 2000
Bell and Howell May 1998 - January 2000
Chiron Corporation January 1994 - May 1998
Space Systems Loral January 1991 - January 1994
Skills
Quality Assurance, Engineering, Integration, CAPA, Embedded Software, Quality System, V&V, Testing, FDA, Change Control, Validation, ISO 13485, ISO 14971, 21 CFR Part 11, Process Simulation, R&D, Design Control, Computer System..., Medical Devices, Software Quality..., GxP, ISO, Quality Control, Sop, DMAIC, Design of Experiments, Software Documentation, Quality Auditing, GMP, Root Cause Analysis, Quality Management, GAMP, FMEA, Regulatory Affairs, Document Management, LIMS, Regulatory Requirements, Regulatory Submissions, Technology Transfer, GLP, SOP
Education
Slippery Rock University of Pennsylvania 1977 — 1980
Bachelor of Science (BS), Mathematics
University of Southern California
Post Grad Studies, Management Information Systems and Services
Case Western Reserve University
Computer Software Engineering
Validant June 2012 - November 2012
EMD Millipore Corporation January 2012 - June 2012
EMD Millipore August 2010 - January 2012
Millipore November 2009 - August 2010
Thermo Fisher Scientific May 2006 - November 2009
Thermo Fisher Scientific January 2005 - May 2006
Philips Healthcare July 2003 - December 2004
Agilent Technologies January 2001 - July 2003
Skills
Strategic Planning, Services Marketing, Business Plan..., Services Management, Portfolio Management, Thought Leadership, Process Improvement, Customer Retention, Contract Management, Business Planning, Service Management, Management, CRM, Product Management, Marketing Management, Strategy, Program Management, Competitive Analysis, Product Development, Budgets, Product Launch, Cross-functional Team..., Medical Devices, Six Sigma, Training, Sales Management, Team Leadership, Market Research, Leadership, Business Development, Marketing Strategy, Sales Operations, Marketing, Marketing Communications, Pricing, Market Planning, Sales, Analysis, Integrated Marketing, Go-to-market Strategy, Operations Management, Market Analysis, Brand Management
Education
Simmons College - Simmons School of Management 1994 — 1996
Masters, Business Administration
Boston University 1990 — 1992
B.S., Mass Communication
University of Massachusetts, Amherst 1988 — 1990
National Laser Institute
Millennium Pharmaceuticals August 2014 - Present
Validant April 2013 - July 2014
Biogen Idec July 2008 - February 2013
Alkermes March 2007 - May 2008
Shire Pharmaceuticals 2001 - 2007
Skills
Quality System, Quality Assurance, FDA, CAPA, Medical Devices, Continuous Improvement, Project Management, Management, Biotechnology, Change Control, Life Sciences, Validation, GMP, SOP, Pharmaceutical Industry, 21 CFR Part 11
Education
Northeastern University 2009 — 2011
Master of Science (M.S.), Regulatory Affairs
Sweet Briar College 1985 — 1989
Bachelor's degree, Chemistry
Alcon Laboratories, Inc. January 2013 - Present
Alcon Laboratories, a Novartis company June 2012 - Present
Alcon Laboratories, a Novartis company July 2011 - June 2012
CIBA Vision April 2010 - July 2011
Validant February 2009 - January 2010
Cordis August 2007 - May 2008
Cordis March 1990 - April 2007
Skills
FDA, CAPA, Quality System, ISO 13485, Regulatory Affairs, Medical Devices, Pharmaceutical Industry, Quality Auditing, Quality Assurance, Regulatory Requirements, Design Control, Manufacturing, Six Sigma, Quality Management, V&V, Design of Experiments, GLP, GMP, Validation, Continuous Improvement, Process Improvement, Sop, 21 CFR Part 11, Quality Control, ISO 14971, Regulatory Submissions, Computer System..., GxP, Change Control, Aseptic Processing, ISO, Technology Transfer, SOP
Education
University of Phoenix
B.S., Business Management
Miami Dade College
Associate of Science (A.S.), Business Administration and Management, General
Teva Pharmaceuticals WriterSelfOctober 2014 - Present
Synthes September 2013 - October 2014
Validant January 2013 - August 2013
Swift Textile Metalizing LLC January 2012 - November 2012
Keane Contracted to Pfizer 2006 - March 2011
Pfizer 2006 - 2008
Keane Inc. 2005 - 2008
Advanced BioPhotonics Inc. October 2002 - September 2005
Viatronix November 2000 - September 2002
Performance Services International, Inc. 1997 - 1998
Skills
Quality Assurance, Quality Management, 21 CFR Part 11, Validation, SDLC, FDA, Process Improvement, Software Quality..., PMP, Document Management, Change Control, Technical Writing, GxP, Quality System, Continuous Improvement, Testing, Software Documentation, Cross-functional Team..., Management, Quality Control, GMP, Quality Auditing, FMEA, Cleaning Validation, 21 CFR, Medical Devices, ISO, Internal Audit, Pharmaceutics, Supplier Quality, Calibration, CAPA, Computer System..., ISO 13485, Regulatory Affairs, Manufacturing, Iso 9000, ISO 14971, V&V, Pharmaceutical Industry, Sop, Design Control, Six Sigma, R&D, Process Engineering, Software Project..., SOP
Education
University of North Texas 1974 — 1987
BA, Journalism
Hofstra University 1972 — 1974
Biology
BFH Consulting, LLC February 2011 - Present
Validant April 2014 - Present
ALKU December 2013 - March 2014
Validant April 2013 - November 2013
Validant August 2011 - April 2013
Abbott Laboratories June 2009 - January 2011
Abbott Laboratories February 2004 - May 2009
Abbott Laboratories January 2002 - January 2004
Abbott Diagnostics 1989 - 2001
Abbott Laboratories May 1983 - June 1989
Skills
CAPA, FDA, Nutrition, Pharmaceutical Industry, ISO 13485, Medical Devices, 21 CFR Part 820, Quality System, Validation, V&V, GMP, International Operations, Regulatory Affairs, Quality Assurance, Process Improvement, Cross-functional Team..., Technology Transfer, Quality Auditing, Change Control, ISO 14971, ISO, R&D, Product Development, 21 CFR Part 11, Quality Management, Manufacturing, FMEA, Product Launch, Testing, Quality Control, Sop, Root Cause Analysis, GLP, Biomedical Engineering, Design of Experiments, DMAIC, Supply Chain, SPC, Cold Chain, Packaging Engineering, Process Simulation, Supply Chain Management, Six Sigma, SOP
Education
Purdue University Calumet
Bachelor's degree, Electrical Engineering Technology
DePaul University
Business Administration, Management and Operations
JOHNSON & JOHNSON, MCNEIL CONSUMER HEALTHCARE November 2012 - Present
Validant November 2012 - Present
LIFE MATTERS, INCORPORATED September 2005 - November 2012
BECTON DICKINSON-BD DIAGNOSTICS February 2012 - September 2012
Eisai February 2006 - March 2010
Skills
Results-driven QA/QC..., Technical Writer, Documentation-Subject..., Documentation Practices..., Enterprise Resource..., Microsoft Suite, Lotus..., SAP, Microsoft Office, Food, Lotus Notes, IBM iSeries, Quality Assurance, Vendor Management, Team Building, Business Analysis, Management, Analysis, Quality System, Team Leadership, Training, Project Planning, Change Management, Cross-functional Team..., Process Improvement, Visio, Project Management, MS Project, SharePoint, CAPA, SDLC, Sop, Human Resources, SOP, Leadership, GMP
Education
East Carolina University 1983 — 1987
Bachelor of Science, Industrial Technology, Technical Sales and Services
ETHICON Johnson & Johnson June 2015 - Present
Thermofisher Scientific November 2014 - March 2015
Baxter Healthcare via USDM October 2011 - December 2013
Leica Microsystems January 2011 - June 2011
Regulatory Compliance Associates, Inc. August 2010 - January 2011
US Data Management January 2009 - November 2010
US Data Management November 2009 - May 2010
2009 - 2009 Validant Consulting November 2009 - May 2010
Validant July 2009 - October 2009
Cardinal Health May 2006 - August 2008
Skills
CAPA, FDA, V&V, Quality System, Software Documentation, Root Cause Analysis, 21 CFR Part 11, Validation, GMP, Change Control, Sop, Pharmaceutical Industry, Biotechnology, Calibration, Computer System..., Cross-functional Team..., Design Control, FMEA, GLP, GxP, Hardware Diagnostics, ISO, ISO 13485, LIMS, Lifesciences, Manufacturing, Medical Devices, Pharmaceutics, Process Improvement, Quality Assurance, Quality Auditing, Quality Control, Regulatory Affairs, Regulatory Requirements, Six Sigma, Technical Writing, Testing, Trackwise, Documentation, Training, Continuous Improvement, Document Management
Education
Illinois State University 1993 — 1995
Bachelor, Biology
in Medical Laboratory Technology @ CLC 1993 — 1995
Bachelor of ScienceAssociate of Applied Science, Biology @ ISU
Quality Executive Partners (QxP) November 2012 - Present
Kevin Rote PhD Consulting LLC November 2012 - Present
Validant March 2012 - November 2012
Emergent Biosolutions September 2010 - February 2012
Amgen December 2006 - September 2010
Abbott Diagnostics July 2002 - November 2006
Abbott Diagnostics 1995 - July 2002
Abbott Diagnostics 1988 - 1995
Howard Hughes Medical Institute 1985 - 1988
Skills
CAPA, FDA, Validation, Quality System, GMP, Design Control, Change Control, Medical Devices, Sop, Technology Transfer, Biotechnology, Pharmaceutical Industry, GxP, Quality Assurance, Quality Control, Risk Management, Quality by Design, Investigation, Supplier Quality, Biopharmaceuticals, Lifesciences, Quality Management, Regulatory Requirements, R&D, SOP
Education
Illinois Institute of Technology 1997 — 1999
Masters, Stuart School of Business: Operations and Technology Management
University of Utah 1979 — 1985
Ph.D., Biochemistry
East Stroudsburg University of Pennsylvania 1974 — 1979
BA, Biology (1978) / Biochemistry (1979)
Stroudsburg High School 1970 — 1974
diploma
Validant September 2014 - Present
R&Q June 2014 - September 2014
Maetrics, LLC January 2014 - June 2014
Hospira January 2012 - January 2014
Ethicon Endo-Surgery April 2010 - January 2012
Mercy Mt. Airy Hospital August 2009 - December 2011
Riverhills Healthcare, Inc. October 2008 - August 2009
Innovex April 2005 - November 2007
Skills
Clinical Research, Cardiology, Healthcare, Medical Devices, Oncology, Hospitals, Clinical Trials, Surgery, Neurology, Medicine, Managed Care, Critical Care, Diabetes, Patient Safety, FDA, Regulatory Affairs, Pharmaceutical Industry, ISO 13485, CAPA, SOP, GCP
Education
Concordia University-Wisconsin 2002 — 2005
BSN, Nursing
CorePharma LLC December 2012 - Present
Validant April 2012 - September 2012
Actavis July 1998 - December 2011
Skills
Validation, Analytical Chemistry, CAPA, GLP, Quality Control, Technology Transfer, Cleaning Validation, HPLC, V&V, Quality Assurance, Laboratory, Chromatography, LIMS, FDA, UV/Vis, Dissolution, Pharmaceutics, Biopharmaceuticals, Quality System, Chemistry, Pharmaceutical Industry, Sop, Change Control, GMP, GxP, Biotechnology, Regulatory Affairs, Aseptic Processing, Regulatory Requirements, Regulatory Submissions, Formulation, Gas Chromatography, 21 CFR Part 11, Computer System..., R&D, Clinical Trials, Quality Auditing, Lifesciences, Microbiology, CRO, SOP
Education
Alexandria University
Bachelor's degree, Chemistry
City Collage of New York
The City University of New York - The City College of New York
Master Program in Chemistry, Chemistry
The FDA Group April 2014 - Present
Oxford Global Resources February 2014 - Present
Validant September 2013 - Present
ASQ 1993 - Present
American Society for Quality 1993 - 2014
Tunstall Americas February 2013 - August 2013
Sealed Air Corporation March 2010 - January 2013
CR Bard August 1990 - March 2010
SCOTT Laboratories April 1985 - August 1990
National Cancer Institute June 1977 - April 1985
Skills
Quality System, ISO 13485, FDA, Quality Management, Root Cause Analysis, Validation, Six Sigma, CAPA, ISO, Medical Devices, GMP, DMAIC, Process Improvement, Lean Manufacturing, ISO 9001, Quality Assurance, Quality Auditing, V&V, Sterilization, Controlled Environments, Aseptic Processing, CQA, SPC, TQM, Cleaning Validation, Supplier Quality, Design Control, Design of Experiments, Process Engineering, Kanban, Regulatory Affairs, FMEA, ASQ, Value Stream Mapping, Operational Excellence, 5S, Microbiology, ISO 14001, Manufacturing, Calibration, Biocompatibility, Six Sigma Black Belt, Continuous Improvement, Mammalian Cell Culture, Minitab, Kaizen, Change Control, Quality Control, ISO 14971, Iso 9000
Education
Anna Maria College 1994 — 1995
MS, Quality Management
Penn State University 1971 — 1976
BS/BS, Biology & Microbiology
Gilead Sciences September 2014 - Present
Validant March 2014 - September 2014
Bayer Healthcare July 2010 - December 2013
DEY Pharma L.P. March 2007 - December 2009
DEY L.P May 2000 - March 2007
Zeneca Ag Products 1993 - 2000
Flint Ink Corporation, Cal Ink Division June 1989 - March 1993
Skills
GMP, Sop, GLP, Formulation Development, Sub-visible particle...
Education
California State University-East Bay
B.S., Chemistry
EG Life Sciences June 2015 - Present
Validant February 2014 - May 2015
Vapotherm January 2013 - December 2013
Vapotherm, Inc August 2009 - December 2012
DENTSPLY International January 2007 - July 2009
Delaware State Parks October 2005 - December 2006
Honeywell International August 2002 - May 2005
MCV Physical Therapy Lab June 2002 - August 2002
Virginia Commonwealth University January 2001 - May 2002
Skills
Regulatory Affairs, Product Development, Technical Support, Medical Devices, FDA, Biomedical Engineering, ISO 13485, Design Control, Validation, Lifesciences, CAPA, Quality System, Manufacturing, Cross-functional Team..., Six Sigma, Lean Manufacturing, Sop, Design of Experiments, V&V, Quality Assurance
Education
Johns Hopkins University Advanced Academic Programs 2013 — 2016
Master's degree, Biotechnology Enterprise/Entrepreneurship
Villanova University 2010 — 2011
Certificate, Lean/Six Sigma
Virginia Commonwealth University 2000 — 2005
B.S., Biomedical Engineering
Artesyn Embedded Technologies May 2013 - Present
Validant November 2012 - May 2013
Integra LifeSciences November 2012 - May 2013
Jabil August 2009 - August 2012
Medtronic February 2009 - May 2009
Medtronic 2002 - 2008
Medtronic 2000 - 2002
Medtronic 1998 - 2000
Medtronic 1993 - 1998
Medtronic October 1996 - April 1997
Skills
Lean Manufacturing, Quality System, Quality Auditing, FDA, ISO, Six Sigma, Business Process..., Integration, ERP, Training, MES, Workshop Facilitation, Medical Devices, Global Management, Quality Assurance, ISO 13485, Process Improvement, Cross-functional Team..., Design of Experiments, R&D, Validation, Management, Continuous Improvement, Program Management, SPC, Software Documentation, Process Engineering, Testing, Manufacturing, FMEA, DMAIC, Operational Excellence, Root Cause Analysis, Automation, CAPA, Quality Management, Supply Chain, Minitab, Manufacturing Operations, Manufacturing..., Engineering Management, Process Simulation, Value Stream Mapping, Business Process, Project Planning, Design Control, Kaizen, Industrial Engineering, Product Development, Iso 9000
Education
Arizona State University 1982 — 1984
MS, Industrial Engineering
Arizona State University 1976 — 1980
BA, Mathematics
Black Diamond Networks October 2014 - April 2015
Radiant Systems Inc. March 2014 - June 2014
Validant April 2013 - July 2013
Validant June 2012 - March 2013
Engineering & Research Associates January 2011 - June 2011
Ventana Medical Systems Inc October 2007 - January 2011
Westmed Inc June 2005 - October 2007
Modern Engineering April 2002 - September 2003
Abbott Laboratories August 1993 - July 2001
Skills
Electronics, Validation, RF, Diagnostics, Medical Devices, Lean Manufacturing, Manufacturing, Product Development, Engineering, Testing, AutoCAD, Solidworks, Process Development, Troubleshooting, Assembly, Automation, Supervisory Skills, Process Improvement, Process Engineering, Problem Solving, Quality Assurance, Program Management, Documentation, FDA, PLC, Root Cause Analysis, Software Documentation, Cross-functional Team..., Quality System, Quality Control, Minitab, V&V, Sop, Injection Molding, Process Simulation, ISO 13485, 5S, Design Control, FMEA, Manufacturing..., CAPA, Hardware Diagnostics, Project Management, Manufacturing..., Kaizen, Supply Chain, Design for Manufacturing, 21 CFR, GMP, Iso 9000
Education
Arizona State University 1972 — 1975
Bachelor of Science (B.S.), Electronic Technology
Grifols September 2014 - Present
Validant April 2012 - September 2014
ABC Laboratories December 2011 - April 2012
Libby Labs July 2008 - November 2011
Pharmaceutical Services Corp October 2006 - October 2007
Impax Laboratories September 2003 - September 2006
Bayer Pharmaceuticals 2002 - 2002
Skills
FDA, Validation, Regulatory Affairs, Biotechnology, Pharmaceutical Industry, 21 CFR Part 11, CAPA, GMP, Sop, Change Control, Quality Assurance, Quality System, Regulatory Submissions, Quality Control, GxP
Education
California State University-East Bay 2008 — 2011
MS, Statistics
University of California, Berkeley 1996 — 2000
Bachelor of Arts (BA), Molecular and Cell Biology
Center for Employment Opportunities September 2013 - Present
3 Bridge Networks April 2013 - July 2013
Validant September 2011 - August 2012
Validant February 2011 - September 2011
The Ascent Services Group 2010 - 2010
Skills
Pharmaceutics, Research, Cross-functional Team..., Technical Recruiting, Recruiting, CAPA, Quality Assurance, Change Management, Management Consulting, Strategy, Temporary Placement, Quality System, Program Management, Enterprise Software, Process Improvement, Project Management, Sourcing, 21 CFR Part 11, Consulting, Temporary Staffing, Training
Education
University of California, Berkeley 2007 — 2009
B.A., Sociology
Contra Costa College 2005 — 2007
General Education and Sociology
F.I.D.M. Fashion Institute of Design and Merchandising 2003 — 2005
Associate of Arts (A.A.), Business Merchandise and Marketing
A T0 Z Pharma Consulting January 2006 - Present
Tunnell Consulting, Inc. 2012 - 2014
Validant 2012 - 2012
Tunnell Consulting 2010 - 2012
Alpharma 2007 - 2009
Tunelle Consulting 2006 - 2007
Bristol-Myrs Squibb Co. 1996 - 2006
GlaxoSmithKline May 1978 - September 1996
Skills
Process Development, Generics, cGMP, Validation, Technology Transfer, Product Development, R&D, Formulation Development, Process Improvement, GMP, Generic Programming, Formulation, Process Simulation, FDA, V&V, Sop, Pharmaceutics, Pharmaceutical Industry, 21 CFR Part 11, GLP, HPLC, Regulatory Affairs, Manufacturing, Biotechnology, Change Control, Quality System, CAPA, Biopharmaceuticals, Regulatory Submissions, Lifesciences, Root Cause Analysis, GxP, Computer System..., Drug Development, Clinical Development, Medical Devices, Drug Delivery, Quality by Design, Regulatory Requirements, Chemistry, Vaccines, Clinical Trials, SOP
Education
New Jersey Institute of Technology 1979 — 1984
Masters, Chemistry
SeaSpine March 2015 - Present
Maetrics October 2013 - April 2015
Allergan Medical November 2012 - June 2013
Terumo April 2011 - November 2012
Validant October 2010 - November 2012
Hospira 2010 - 2011
Abbott Vascular Devices April 2006 - June 2010
Advanced Bionics April 2005 - March 2006
TUV America March 2003 - March 2005
Advanced Sterilization 2002 - 2003
Skills
Quality Systems, Supplier Quality, Business Process..., ISO 13485, Training, Management Review, CAPA, FDA, Quality System, Document Management, Quality Management, V&V, Internal Audit, GMP, Adverse Event Reporting, Medical Devices, Quality Assurance, Quality Auditing, Design Control, ISO 14971, Root Cause Analysis, Six Sigma, GxP, Iso 9000, ISO, SPC, Risk Management, 21 CFR Part 11, Quality Control, Biotechnology, FMEA, Process Improvement, Software Documentation, Validation, Manufacturing, Aseptic Processing, Cross-functional Team..., Change Control, Auditing, Computer System..., Sop, Regulatory Submissions, Regulatory Affairs, R&D, Pharmaceutical Industry, Technology Transfer, GLP, Clinical Trials, Process Simulation, Biopharmaceuticals
Education
University of Phoenix 2006 — 2009
MBA, Business
California State University-Long Beach 1972 — 1976
BSIT, Quality Asssurance Specialty
Egalet April 2015 - Present
Validant October 2014 - April 2015
Rockward Pharmaceutical Consultants January 2014 - September 2014
Actient Pharmaceuticals, LLC (now Auxilium Pharmaceuticals) October 2012 - December 2013
Avid Radiopharmaceuticals July 2012 - October 2012
Medicis (now Valeant Pharmaceuticals) December 2011 - April 2012
Graceway Pharmaceuticals September 2008 - December 2011
Novavax, Inc April 2001 - August 2008
Cardinal Health July 2000 - April 2001
Aventis August 1999 - May 2000
Skills
GMP, FDA, Quality Assurance, Validation, Technology Transfer, Compliance, Strategic Planning, Contract Negotiation, cGMP, Sop, Quality System, Start-ups, Project Management, Process Improvement, Pharmaceutical Industry, Change Control, Business Planning, Lifesciences, CAPA, Cross-functional Team..., Continuous Improvement, V&V, Regulatory Submissions, IND, Product Launch, Regulatory Requirements, Cleaning Validation, Due Diligence, Microbiology, Management, Manufacturing, Commercialization, Parenteral, Leadership, FDA GMP, Aseptic Processing, Inspection, Risk Assessment, Commissioning
Education
Gwynedd Mercy University 1992 — 2000
Bachelor of Science, Biology
Temple University 1981 — 1983
Jazz/Jazz Studies
Drexel University 1977 — 1979
Engineering
Integra LifeSciences October 2014 - Present
Validant May 2014 - October 2014
LifeCell Corporation July 2013 - May 2014
LifeCell Corporation November 2009 - July 2013
Our Lady of Lourdes Health Care System May 2007 - November 2009
Gife of Life Donor Program September 2003 - May 2007
The Julian Krinsky Group June 2003 - July 2006
Deborah Heart and Lung Center/ Deborah Hospital January 1991 - September 2003
United States Army Reserve June 1988 - April 2000
Robert Wood Johnsson University Hospital Hamilton January 1989 - January 1991
Skills
Quality Assurance, Donor Suitability, Documentation Practices, Nursing Documentation, QA Documentation, Change Control, Process Quality..., Critical Care, Quality Patient Care, Organ and Tissue..., Transplant, Clinical Research, EMS, Process Improvement, Healthcare, Software Documentation, Cross-functional Team..., Hospitals, Healthcare Management, Surgery, ACLS, Nursing, Kidney Transplant, BLS, Project Management, FDA, Managed Care, Nursing Education, Oncology, Clinical Trials, Medical Devices, Cardiology, Orthopedic, Medical/Surgical, ICU, Medicine, Infectious Diseases, Biotechnology, Cancer, EMR, Patient Safety
Education
University of Phoenix 2013 — 2016
MHA-Informatics, Healthcare Administration/Informatics
The College of New Jersey 1985 — 1988
BSN, Nursing
Michigan State University 1982 — 1984
pre-nursing
Siemens Healthcare May 2015 - Present
Vital Signs, Inc. / CareFusion September 2010 - May 2015
Validant June 2010 - September 2010
Pfizer October 2009 - November 2009
Wyeth November 2008 - October 2009
Wyeth Biotech May 2005 - November 2008
Wyeth January 2005 - April 2005
Wyeth October 2002 - December 2004
Wyeth March 2002 - September 2002
Vertek Corporation June 2000 - August 2001
Skills
Change Control, FDA, Validation, GMP, Sop, Pharmaceutical Industry, 21 CFR Part 11, CAPA, Quality System, Quality Assurance, Medical Devices, Six Sigma, Process Improvement, Cross-functional Team..., GxP, Testing, Manufacturing, Software Documentation, Technical Writing, SDLC, Root Cause Analysis, Quality Management, Regulatory Affairs, Quality Control, ISO 13485, Engineering, V&V, Lean Manufacturing, SOP
Education
Rutgers, The State University of New Jersey-New Brunswick
Bachelor of Science, Mechanical/Aerospace Engineering
Fairleigh Dickinson University
MBA, Management
Novartis Animal Health November 2012 - Present
Validant April 2012 - November 2012
Biogen Idec July 2011 - April 2012
GlaxoSmithKline August 2007 - July 2011
GSK 2007 - July 2011
Abraxis Oncology March 2007 - August 2007
DanChem Technologies, Inc. 2004 - 2007
Wyeth February 2001 - September 2006
AAI Development Services December 1998 - February 2001
Skills
FDA, CAPA, Validation, Quality Assurance, SOP, Change Control, GMP, Quality System, Pharmaceutical Industry, Quality Auditing
Education
North Carolina Agricultural and Technical State University 1990 — 1997
Bachelor of Science (BS), Chemistry
Oxford Global Resources (Covidien GI Solutions part of Medtronic) May 2015 - Present
Orion Consulting Group, LLC June 2012 - Present
American Contractors Corp. April 2015 - May 2015
Validant September 2014 - December 2014
Validant May 2014 - August 2014
Black Diamond Networks January 2014 - March 2014
The Evanston Group August 2012 - December 2013
Maetrics, LLC February 2011 - July 2012
Maetrics, LLC - Compliance, Quality & Technology Consultants September 2009 - February 2011
Maetrics, LLC September 2009 - October 2009
Skills
Analytics, Asset Managment, Auditing, Budgeting, Continuous Improvement, cGMP manufacturing, Business, Business Development, Customer Service, Configuration Management, Entrepreneurship, ISO, iPhone, Key Account Development, Kaizen, Leadership, Lifesciences, Medical Devices, Microsoft Office, Microsoft Excel, Microsoft Word, Mathematics, Non-profits, Outsourcing, Organization, PowerPoint, PMP, Problem Solving, Quality Assurance, Quality Management, Quality System, Regulatory Affairs, Sustainability, SOA, Visio, Program Management, FDA, Manufacturing, Budgets, Nonprofits, SPC, Cross-functional Team..., Process Improvement
Education
Cornerstone University 2008 — 2009
M.B.A., Business Administration - (international emphasis)
Michigan State University 1985 — 1989
B.S., Physical Science (mathematics / engineering)
Michigan Technological University 1983 — 1984
Undergrad Studies, Computer Science & Engineering, Freshmen & Sophomore
Harrison High School 1980 — 1983
Diploma, Math and Sciences
REI October 2012 - Present
Long and Foster March 2011 - 2013
The Proper Property Proprietary February 2011 - 2013
Episcopal High School February 2011 - June 2012
CAL Sailing March 2010 - June 2010
Validant October 2009 - March 2010
"Ride!" They Cried May 2009 - August 2009
Burke & Herbert Bank & Trust January 2009 - May 2009
Pacific Expeditions Ltd. February 2008 - April 2008
Austin Grill May 2006 - August 2006
Skills
VA Real Estate Lisence, Microsoft Office, Photoshop, HTML, Website Development, Business Communications, Conflict Resolution, Real Estate, Team Building, Market Research, Coaching, Management, Customer Service, Public Relations, Social Media, Nonprofits, Teaching
Education
Northern Virginia Community College 2011 — 2011
Automotive Engineering
Bond University 2007 — 2008
University of Mary Washington 2004 — 2008
Bachelor of Science, Business Administration
Intercom 2015 - Present
Validant 2012 - 2015
J.P.Morgan 2011 - 2012
Skills
Consulting, Pharmaceutical Industry, Investments, Pharmaceutical..., New Business Development, Screening Resumes, Excel, Asset Allocation, Leadership, Strategic Financial..., Market Research, Finance, Program Management, Portfolio Management, Strategy, Process Improvement, Microsoft Excel, Business Development, CRM, Marketing
Education
Baylor University - Hankamer School of Business
BBA, Finance/Economics
The Woodlands High School
Westlake High School
LexaMed February 2014 - Present
Synergy Health July 2012 - December 2013
Medtronic December 2011 - July 2012
Validant December 2010 - December 2011
Maetrics LLC April 2008 - December 2010
LexaMed November 2007 - April 2008
J & J Scientific Products February 2007 - December 2007
Baxter Healthcare February 2005 - January 2007
MasterTaste November 2003 - December 2004
ASO Corporation June 2001 - November 2003
Skills
CAPA, Validation, FDA, ISO 13485, Medical Devices, V&V, Quality System, FMEA, Manufacturing, Regulatory Affairs, Continuous Improvement, Quality Assurance, SPC, ISO, Sop, Quality Auditing, Change Control, GMP
Education
Gannon University 1981 — 1985
Bachelor of Science, Biology
Validant January 2012 - Present
WaazApp Inc. December 2011 - Present
Amgen Corp September 2009 - December 2012
Amgen Corp--Login Consultants (LCS) March 2007 - September 2009
Tamarisc Diagnostics April 2005 - September 2007
Kaiser Foundation Health Plan September 2003 - April 2005
LifeScan 2000 - March 2003
Kyphon, inc 1997 - April 2000
Skills
Lean Six Sigma Master..., Financial Cost-Out, Business Management..., FDA Audits / QSR, Medical Device /..., Process Improvement, Business Process..., Program Management, Operations Management, Start-ups, Business Development, Change Management, ERP, Lean Manufacturing, Management, Management Consulting, Negotiation, Product Development, Quality Assurance, Six Sigma, Strategic Planning, Training
Education
California Lutheran University 2010 — 2012
Master of Business Administration (MBA), Finance, 3.93
California State University-Dominguez Hills 1992 — 1994
MS, Quality Assurance, 3.87
California State Polytechnic University-Pomona 1984 — 1988
BS, Engineering
Oxford International July 2015 - Present
PharmaBio Serv June 2015 - July 2015
Maetrics, LLC March 2013 - December 2014
Validant July 2012 - March 2013
Piramal Critical Care, Inc October 2010 - June 2012
Validant March 2010 - October 2010
Halo Pharmaceuticals, Inc. January 2009 - April 2010
Abbott Laboratories August 2003 - December 2008
Skills
Quality Management, Quality Systems Design, Quality System..., cGMP practices, CFR Part 210 & 211, CFR 21 Part 820, ISO 13485, Quality Auditing, ICH guidelines, Validation, FDA, Quality Assurance, FDA GMP, Quality Control, Quality System, GxP, CAPA, GMP, Six Sigma, Medical Devices, Root Cause Analysis, Cross-functional Team..., 21 CFR Part 11, Pharmaceutical Industry, Regulatory Affairs, SOP, Change Control, GLP, V&V, Process Improvement
Education
Lehigh University - College of Business and Economics 1997 — 2002
MBA, General Administration
Penn State University 1968 — 1972
Bachelor's degree, Ceramic Sciences and Engineering
Tunnell Consulting, Inc. June 2015 - Present
Validant February 2010 - May 2015
PII March 2009 - November 2009
Tobira Therapeutics June 2008 - February 2009
Bristol-Myers Squibb June 1982 - February 2008
Bristol-Myers Squibb 1982 - 2008
Skills
Quality Assurance, Quality Systems, Quality Management, Document Management, Information Management, Investigations, CAPA, Business Process..., Change Management, Private Investigations, Quality System, FDA, GMP, V&V, Quality Control, Validation, Testing, Change Control, Trackwise, Pharmaceutics, GLP, Drug Development, Quality Auditing, Sop, Software Documentation, LIMS, 21 CFR Part 11, R&D, Computer System..., GCP, IND, Formulation, Cleaning Validation, GxP, Technology Transfer, Regulatory Affairs, GAMP, Biopharmaceuticals, SOP, Pharmaceutical Industry, TrackWise
Education
Fairleigh Dickinson University 1983 — 1987
MBA, Pharmaceutical/Chemical Studies
Binghamton University 1978 — 1982
B.S., Chemistry
Ramapo Senior High School
consultancy October 2014 - Present
Validant May 2013 - Present
Boston Scientific 2014 - 2015
Boston Scientific 2014 - 2015
Boston Scientific 2014 - 2015
Boston Scientific 2014 - 2015
Varian Medical Systems 2013 - 2014
Philips January 2011 - November 2011
Consultant, Anson Group July 2010 - January 2011
none February 2008 - April 2010
Skills
Medical Devices, ISO 13485, FDA, Regulatory Affairs, Validation, Quality Assurance, Quality Auditing, Biotechnology, Pharmaceutical Industry, Cross-functional Team..., 21 CFR Part 11, R&D, Process Improvement, Sop, Product Launch, ISO, CAPA, Quality System, Training, Auditing, Complaint Management, ISO 14971, GMP
Education
California State University-San Marcos 2003 — 2004
Bachelor of Arts (BA), Social Psychology
Southern Cross University 2003 — 2003
Exercise Science, Kinestheology
Maxim Healthcare Services August 2015 - Present
Kelly Scientific Resources September 2013 - September 2014
Validant October 2012 - August 2013
Validant April 2012 - October 2012
Central Coast Pathology June 2010 - January 2011
Cal Poly Phone-a-thon January 2009 - December 2010
Catholic Youth Organization December 2003 - February 2007
Skills
FDA, Biotechnology, Validation, PCR, Medical Devices, GMP, Quality System, Technical Recruiting, CAPA, Microbiology, Microsoft Office, V&V, GLP, Microscopy, Quality Assurance, Spectrophotometry, Gel Electrophoresis, Recruiting, Sourcing, Direct Hires, Temporary Staffing
Education
California Polytechnic State University-San Luis Obispo 2007 — 2011
B.S., Molecular and Cellular Biology, Minor in Philosophy
Foothill High School 2004 — 2007
Fresenius Medical Care November 2014 - Present
Validant August 2014 - November 2014
DOHMEN March 2014 - June 2014
Maetrics, LLC January 2013 - October 2013
HeartWare Inc March 2011 - March 2012
Cordis Corporation February 2005 - March 2011
Baxter Healthcare Corporation January 1999 - January 2001
Skills
Medical Devices, Validation, ISO 13485, FDA, Quality System, Quality Assurance, CAPA, Quality Management, 21 CFR, GMP, ISO 14971, V, Complaint Management, Software Documentation, Sop, V&V, Regulatory Affairs
Education
Florida International University 2006 — 2008
Bachelors, International Business and Management
Validant March 2015 - Present
ASQ 2009 - Present
ASQ July 2006 - Present
MAETRICS November 2014 - March 2015
CardiacAssist, Inc. May 2012 - November 2014
Ducommun LaBarge Technologies, Inc November 2010 - February 2012
Philips Home Healthcare - Respironics June 2007 - November 2010
B. Braun Medical January 2006 - May 2007
St. Jude Medical August 2000 - October 2005
Rocketdyne (Boeing) May 1997 - August 2000
Skills
Quality System, Quality Assurance, ISO 13485, Quality Management, FDA, CAPA, Medical Devices, Six Sigma, DMAIC, Process Improvement, Design Control, Quality Auditing, Supplier Quality, V&V, ISO 14971, Statistics, Manufacturing, Lean Manufacturing, Quality Control, Testing, Continuous Improvement, Process Validation, ISO, Biomedical Engineering, Plastics, Iso 9000, Validation, Design of Experiments, Regulatory Submissions, 510 K, CE marking, Injection Molding, QSR, Quality Engineering, PMA, Engineering, Risk Management, Auditing, cGMP, IDE, Root Cause Analysis, Change Management, Cross-functional Team..., Project Management, Product Development, Medical Device R&D, GMP, SPC, R&D
Education
Penn State University, Graduate School of Business 2008 — 2010
MBA
Pennsylvania State University-Erie Campus 2008 — 2008
California Polytechnic State University-San Luis Obispo 2004 — 2005
MS
University of Southern California 1990 — 1990
MS
The University of Texas at Austin 1984 — 1989
Bachelors of Science
Lanier High School 1980 — 1984
HS Diploma
Charming Charlie March 2015 - July 2015
Manduka November 2013 - January 2015
Manduka November 2011 - November 2013
Manduka March 2011 - November 2011
Validant March 2010 - February 2011
Aronowitz & Mecklenburg December 2008 - January 2010
Skills
Marketing, Research, Content Marketing, Promotions, Eblasts, Google Analytics, Spanish, Foreign Languages, Problem Solving, Teamwork, Communication, Microsoft Excel, Microsoft Word, Outlook, PowerPoint, Organization, Troubleshooting, Meet Deadlines, Fast-paced, Social Media Marketing, Event Management, Retail, Customer Service, Advertising, Blogging, Social Media, Management, Copywriting
Education
Colorado State University 2004 — 2008
Business/Marketing, Marketing
University College Dublin 2006 — 2007
Marketing, International Business/Marketing
Hola Spanish in Buenos Aires
Spanish
Regeneron Pharmaceuticals, Inc. August 2013 - January 2014
Validant December 2012 - April 2013
Bristol-Myers Squibb 2010 - 2012
Sanofi June 2009 - September 2010
Daiichi Sankyo, Inc. February 2009 - May 2009
Johnson & Johnson January 2008 - September 2008
Bristol-Myers Squibb February 2007 - July 2007
Pryor Cashman LLP January 2000 - July 2007
Ian Schrager Company , Royalton Hotel March 1999 - September 1999
Skills
Pharmaceutical Industry, Validation, Change Control, GMP, FDA, Biotechnology, Technology Transfer, Sop, Cross-functional Team..., SDLC, Quality Assurance, Process Improvement, Change Management, Quality System, Software Documentation, Project Management, 21 CFR Part 11, Sarbanes-Oxley, Regulatory Affairs, Compliance
Education
Long Island University, CW Post 1989 — 1992
Long Island University, C.W. Post Campus
General Assembly September 2015 - Present
Freelance April 2015 - Present
Wheel House April 2015 - Present
Validant April 2013 - August 2015
Nanosolar November 2012 - February 2013
University of Vermont June 2010 - August 2012
Skills
Sketch, User Experience Design, Visual Design, Design Thinking, Rapid Prototyping, InVision, User Experience, Interaction Design, Graphic Design, Adobe Creative Suite, Designing, Research, Illustrator, Data Analysis, Vector Illustration, Ecology, Microsoft Office, Field Work, Chemistry, Laboratory, Data Entry, Biology, Experimental Design, Environmental Science, Performance Metrics, Aquatic Ecology, Taxonomy, Database Integrity, Cross-functional Team..., Kicking Ass, Scientific Writing, Ecological Research, Social Media, Management, Leadership, Customer Service, Database Administration, Applicant Tracking...
Education
General Assembly
User Experience Design Immersive
General Assembly
Visual Design
University of Vermont
Bachelor of Arts (B.A.), Biology, Chemistry, Studio Art
Validant March 2009 - Present
Validant October 2012 - December 2014
Validant March 2012 - October 2012
Validant March 2011 - March 2012
Validant March 2009 - March 2011
Sun Valley Resort September 2007 - October 2008
Vista Research January 2006 - August 2007
Beretta International September 2005 - January 2006
Spanish Bay Golf Links- Pebble Beach June 2003 - September 2004
Skills
Product Development, Manufacturing, Lifesciences, Engineering, Medical Devices, ISO 13485, Regulatory Affairs, Biotechnology, FDA, Cross-functional Team..., Validation, Quality System, Clinical Trials, V&V, Minitab, Regulatory Submissions, Product Launch, 21 CFR Part 11, Strategy, Quality Auditing, Sop, Quality Assurance, Quality Management, Biopharmaceuticals, FMEA, GxP, Pharmaceutical Industry, ISO, Technology Transfer, DMAIC, Change Control, R&D, CAPA, Lean Manufacturing, Software Documentation, Pharmaceutics, Start-ups, Process Improvement, SPC, Computer System..., Design of Experiments, Operational Excellence, Six Sigma, Continuous Improvement, Quality Control, Root Cause Analysis, GMP, Process Engineering, Process Simulation, Regulatory Requirements
Education
Lehigh University - College of Business and Economics 2001 — 2005
Finance, International Finance, Minor in Philosophy
Københavns Universitet 2004 — 2004
International Finance
Robert Louis Stevenson 1997 — 2001
ProPharma Group July 2014 - Present
Validant 2012 - 2014
Lab Support, a division of On Assignment August 2010 - November 2012
Opus Regulatory August 2005 - April 2010
Cambridge Search 2001 - 2005
Modis 1999 - 2001
Skills
Biotechnology, Packaging, Diagnostic, Chemical, Contract Testing Lab, Environmental, Industrial Manufacturing, Medical Device, Medical Research Labs, Pharmaceutical, Computer System..., Validation, Cleaning Validation, Process Improvement, Quality Assurance, Regulatory Affairs, Global Regulatory..., Medical Information..., Complaint Management, Commissioning, Technology Transfer, Compliance, Manufacturing Operations, Process Engineering, Program Management, Project Management, Business Development
Education
Colby College 1990 — 1994
BA
Validant November 2013 - Present
Beckman Coulter May 1990 - October 2013
Loral Electro-Optical Systems June 1985 - May 1990
Skills
Design Control, Medical Devices, FMEA, FDA, Six Sigma, Lean Manufacturing, DMAIC, ISO, SPC, Quality Systems, Root Cause Analysis, Cross-functional Team..., ISO 13485, Process Improvement, Cost Reduction, Validation, CAPA, Quality Engineering, Quality Assurance, MS Project, Documentation, Problem Solving, Continuous Improvement, Program Management, Minitab, Quality Management, Kaizen, Value Stream Mapping, Excel, Microsoft Office, 5S, Manufacturing, Software Documentation, Supplier Quality, Quality Auditing, Quality Control, Microsoft Excel, GMP, Design of Experiments, Quality System, V&V, R&D, Design for Manufacturing, 21 CFR Part 11, Process Simulation, ISO 14971, CQE, Injection Molding, Hardware Diagnostics, Biomedical Engineering
Education
California State University-Fullerton, Mihaylo College of Business and Economics 1991 — 1993
MBA, Business
California State Polytechnic University-Pomona 1979 — 1985
BSME, Mechanical Engineering
Delta Project Management May 2014 - Present
Validant April 2012 - May 2014
Art Institute of California - San Francisco August 2011 - April 2012
Academy of Art University September 2008 - October 2010
American InterContinental University September 2007 - September 2008
CareerBuilder.com May 2007 - September 2007
Skills
Academia, Salesforce.com, Student Development, Interviews, Process Improvement, Human Resources, Analysis, Campus, Cross-functional Team..., Strategy, Employee Training, V&V, Project Planning, Consulting, GMP, Technical Recruiting, Staff Development, Admissions, Validation, Biotechnology, FDA, Leadership, Management, Pharmaceutical Industry
Education
North Park University 2003 — 2007
Bachelor of Arts (B.A.), Sociology
Bulletproof Documentation, Inc. September 2015 - Present
QualComp Consulting Services at Maquet Cardiovascular April 2014 - May 2014
Abbott Medical Optics June 2012 - September 2013
Endologix Inc November 2011 - December 2011
Southern Implants, Inc. August 2010 - October 2011
Medtronic Medical Devices December 2009 - August 2010
Validant October 2009 - November 2009
Alpine Biomed February 2007 - April 2009
Edwards Lifesciences September 1999 - November 2006
Skills
FDA, CAPA, Quality System, ISO 13485, Medical Devices, Validation, V&V, Change Control, ISO, Sop, Document Management, Software Documentation, Regulatory Affairs, Design Control, Regulatory Requirements, Technical Writing, Version Control, Quality Assurance, ECOs, DCOs, Gap Analysis, DHF, SOPs - Author, Edit,..., EDMS, Agile, Product Configuration, Understand Engineering..., Project Management, GMP, Microsoft Office, Microsoft Word, Microsoft Excel, Consulting, Contractors, 21 CFR Part 11, 21 CFR, Process Improvement, Manufacturing, Quality Auditing, SOP
Education
Baker College Center for Graduate Studies 2003 — 2005
MBA, Industrial Management
University of Phoenix 2001 — 2003
BS, Management
Validant September 2015 - Present
Kredible April 2014 - September 2015
Anteo Group/CSI Companies, a unit of Recruit Holdings Co. Ltd. September 2013 - March 2014
Anteo Group 2002 - September 2013
Allegis Group January 2001 - May 2002
Allegis Group London U.K. July 1996 - December 2000
Andlock, BV Netherlands May 1995 - December 2000
Skills
Strategy, Strategic Planning, Leadership, Change Management, Start-ups, Project Management, IT Strategy, CRM, Integration, Operational Excellence, PMO, Vendor Management, Strategic Consulting, Management Consulting, Professional Services, Business Process..., Business Intelligence, Technology Planning, Technology Evaluation, Program Management, SaaS, Technology..., Business Continuity, IT Service Management, Business Development
Education
Hope College 1988 — 1992
B.A., Business
Gilead Sciences December 2014 - Present
Validant April 2014 - November 2014
Catalent Pharma Solutions January 2002 - February 2014
Magellan Laboratories October 1996 - January 2002
Bristol Myers Product May 1991 - October 1996
Skills
Analytical Chemistry, GMP, Dissolution, HPLC, LC-MS, Drug Development, Sop, Validation, V&V, GLP, Chemistry, Chromatography, Change Control, Technology Transfer, FDA, LIMS, Formulation, 21 CFR Part 11, UV/Vis, UV, Drug Delivery, Gas Chromatography, Cleaning Validation, Analytical Method..., CAPA, Biopharmaceuticals, USP, GxP, Mass Spectrometry, Trackwise, Method Development, CRO, Aseptic Processing, Drug Discovery, Wet Chemistry, Project Management, SOP
Education
North Carolina State University 1986 — 1990
BS, Chemistry
North Carolina State University 1986 — 1990
BS, Chemistry
Hillsboro High School
Dohmen Life Science Services January 2015 - Present
Cincero Investment Properties, Inc. January 2014 - Present
Validant July 2014 - January 2015
Carefusion July 2011 - July 2014
Mentor Corporation April 2009 - May 2011
Medtronic August 2007 - April 2009
Johnson & Johnson July 2004 - August 2007
Janssen Pharmaceutica April 2001 - July 2004
Elgie Inc. August 2000 - March 2001
Johnson & Johnson Medical October 1996 - August 2000
Skills
GMP, V&V, Quality Assurance, Change Control, Design Control, Six Sigma, Quality Auditing, ISO 14971, Quality Control, R&D, Regulatory Submissions, Product Development, Lean Manufacturing, GLP, GxP, Regulatory Requirements, Quality Management, DMAIC, FDA, CAPA, Validation, Quality System, Medical Devices, ISO 13485, Pharmaceutical Industry
Education
Baylor University 1985 — 1990
MS, Chemistry
Texas Wesleyan University 1981 — 1985
B.S., Chemistry
Certified Yoga Instructor April 2014 - Present
MAETRICS September 2014 - January 2015
MAETRICS October 2012 - March 2014
Oxford Global Resources May 2012 - October 2012
QualComp Consulting Services May 2012 - July 2012
Validant September 2011 - May 2012
Rio Salado College February 2010 - July 2010
Virtual Goody Bags, L.L.C. May 2010 - May 2010
Edward Jones October 2009 - May 2010
W.L. Gore & Associates October 2006 - June 2009
Skills
Event Planning, Event Management, Training, Educational Technology, Adult Education, Elementary Education, Quality Assurance, Regulatory Submissions, International..., MDRs, Vigilance
Education
Arizona State University 2010 — 2011
M.A., Language & Literacy, 4.0
Arizona State University 2001 — 2003
B.A., Elementary Education and Teaching
Validant December 2013 - Present
Validant 2011 - December 2013
Bay Equity, LLC April 2010 - October 2011
Guide Dogs for the Blind June 2009 - June 2010
Plaid Ranch LLC June 2003 - June 2008
LicenZing LLC September 2006 - May 2007
Skills
Customer Service, Research, File Management, Newsletters, Press Releases, Database Administration, Employee Relations, HRIS, Benefits Administration, Applicant Tracking..., Talent Acquisition, ADP Payroll, Payroll, FMLA, Onboarding, Deferred Compensation, Interviews, Workforce Planning, Recruiting, Public Relations, Technical Recruiting, Team Building, Training, HR Policies, Personnel Management, Employee Training, Talent Management, Performance Management, Human Resources, Process Improvement, Microsoft Office
Education
Cornell University School of Industrial and Labor Relations 2009 — 2010
Certificate, Human Resources Studies
Dominican University of California 2004 — 2008
BA, Communications
The Fountain Group June 2015 - Present
Validant July 2014 - February 2015
Maetrics, LLC February 2013 - July 2014
Hospira February 2012 - February 2013
Auxilium Pharmaceuticals February 2010 - June 2011
PPD January 2009 - February 2010
Merck June 2007 - December 2009
Thomas Jefferson University December 2006 - June 2007
Medical Diagnostic Laboratory April 2006 - November 2006
Skills
cGMP, HPLC, Chromatography, Protein Chemistry, Medical Devices, Quality System..., 21 CFR Part 11, Root Cause Analysis, CAPA, Organizational..., LIMS, GMP, FDA, Biotechnology, Sop, ELISA, Quality System, Cell, Laboratory, Quality Control, UV/Vis, PCR
Education
Ashford University 2010 — 2012
M.A., Organizational Management
Thomas Jefferson University 2005 — 2007
B.S., Biotechnology
Force Brands - BevForce FoodForce FieldForce January 2015 - Present
Experis April 2011 - January 2015
Hays Finance Technology January 2011 - March 2011
IBM Global Business Services September 2010 - January 2011
Validant September 2009 - June 2010
Hays Pharma March 2007 - August 2009
Skills
Technical Recruiting, Contract Recruitment, Recruiting
Education
Duke University
BA, Economics and Political Science
San Francisco State University
MBA, Management
Designeers Midwest July 2015 - Present
Adecco March 2015 - September 2015
CDI Corporation March 2014 - August 2014
Validant December 2013 - February 2014
Kelly Services October 2014 - 2014
Maetrics, LLC April 2013 - November 2013
Adecco Staffing, USA January 2013 - April 2013
Casual Male Retail Group October 2012 - January 2013
Siemens Building Technologies May 2012 - November 2012
Computershare June 2012 - August 2012
Skills
Quality Assurance, Training, Access, Customer Satisfaction, Customer Service, Call Centers, Software Documentation, Technical Support, SAP, Medical Devices, Microsoft Office, Microsoft Excel, Process Improvement, Lotus Notes, FDA, Call Center, Microsoft Word, Process Scheduler, Oracle, Sales, Outlook, Data Entry, PowerPoint, Teamwork, Management, Retail, Troubleshooting, Leadership, Cross-functional Team..., Data Analysis, Time Management, Customer Support, Research, Social Networking, Customer Experience, Cold Calling, CATSWeb, Account Reconciliation, Compliance, Pilgrim, 21CFR820.198, Analysis, Healthcare, Agile, Inventory Management, MDRs, Medwatch 3500a, eSubmitter, Team Building
Education
University of Phoenix 2006 — 2009
MBA, Business Administration
Framingham State University 1997 — 1999
BA Degree, Sociology
Middlesex Community College 1996 — 1997
A.S., Liberal Studies
University of Massachusetts, Amherst 1994 — 1995
N/A, Undecided
Billerica Memorial High School 1990 — 1994
HS Diploma, College Prep
TESARO January 2015 - Present
Validant August 2014 - January 2015
DKB Consulting 2009 - January 2015
Biogen Idec July 2010 - July 2014
Millennium Pharmaceuticals July 2009 - January 2010
Emergent BioDefense December 2001 - January 2009
Emergent BioDefense Operations December 2001 - January 2009
Emergent BioSolutions December 2001 - January 2009
BioPort Corporation December 2001 - February 2007
ALK-Abello September 1998 - December 2001
Skills
CMC, Auditing, Training, Facilities Management, Regulatory Affairs, FDA, GMP, Regulatory Submissions, Validation, Biotechnology, CAPA, GLP, Pharmaceutical Industry, Biopharmaceuticals, Sop, Change Control, Technology Transfer, V&V, Lifesciences, Clinical Development, Vaccines, IND, Regulatory Requirements, Pharmaceutics, CRO, Drug Development, R&D, Quality System, Medical Devices, Quality Assurance, Clinical Trials, 21 CFR Part 11, Biologics, Purification, eCTD, NDA, HPLC, LIMS, Quality Control, Assay Development, Oncology, ISO 13485, Chromatography, Formulation, Analytical Chemistry, GxP, Drug Discovery, Aseptic Processing, GCP, Pharmacovigilance
Education
University of Michigan 1988 — 1990
MPH, Public Health - Toxicology
Michigan State University 1979 — 1981
BA, Chemistry
Pandora March 2015 - Present
Validant December 2009 - March 2015
BioSearch, LLC April 2007 - December 2009
Genentech May 2006 - April 2007
Genentech March 2003 - May 2006
TechPartners International 2000 - March 2003
Aerotek 2000 - 2000
Skills
Medical Devices, Talent Acquisition, Creative Sourcing, Team Leadership, Biotechnology, Pharmaceuticals, Management Consulting, Healthcare Staffing, Quality Systems, Complaint Handling, Pharmaceutical Industry, Validation, FDA, Regulatory Affairs, Regulatory Submissions, GCP, Human Resources, Pharmaceutics, Strategy, Sop, Executive Search, Manufacturing, Business Development, Healthcare, Oncology, Complaint Management, Quality System, Sourcing, Hiring, Technology Transfer, Management, Leadership, GMP, Lifesciences, Clinical Development, Start-ups, CAPA, Recruiting, Project Planning, Clinical Research, Clinical Trials, Drug Development, CRO, Biopharmaceuticals, CTMS, Cross-functional Team..., Project Management, ISO 13485, R&D, Hardware Diagnostics
Education
University of California, Santa Barbara 1993 — 1997
BA
Monash University 1996 — 1996
Underwriters Laboratories January 2012 - Present
Validant 2011 - January 2012
Tegrant Corporation November 2010 - May 2011
Sloan Valve Company January 2010 - December 2010
Baxter Healthcare 2007 - 2009
Shure Inc. November 2000 - March 2007
Underwriters Laboratories 1986 - 2000
Skills
ISO 14971, Product Development, Medical Device Product..., IEC 62304, Engineering Management, Software Development, Testing, Product Lifecycle..., Medical Devices, Engineering, Cross-functional Team..., Manufacturing, Quality System, Leadership, SPC, Strategy, Kaizen, Process Improvement, R&D, Program Management, Injection Molding, Continuous Improvement, Team Leadership, Project Management, Lean Manufacturing, Product Management, Management
Education
Illinois Institute of Technology 2014 — 2018
Master of Science (M.S.), Computer Science
Illinois Institute of Technology 1992 — 1997
Master of Science (M.S.), Electrical Engineering
University of Illinois at Urbana-Champaign 1982 — 1986
Bachelor of Science, Electrical Engineering
Micell Technologies August 2015 - Present
Validant November 2014 - July 2015
Verathon Medical Inc. July 2013 - October 2014
MedVenture Technology Corporation May 2011 - July 2013
Boston Scientific Corp - Spencer October 2008 - April 2011
Endovascular, Medtronic CardioVascular June 2000 - October 2008
Vascular, Medtronic CardioVascular March 1998 - May 2000
Skills
DOE, Process Validation, Lean Manufacturing, DFM, cGMP, V&V, Design of Experiments, Design for Manufacturing, Catheters, GMP, Medical Devices, Design Control, R&D, ISO 13485, Product Development, Six Sigma, Validation, 21 CFR, CAPA, FMEA, Quality System, Manufacturing..., FDA, Engineering, Minitab, Cross-functional Team..., ISO 14971, DMAIC, SPC, Injection Molding, Root Cause Analysis, Biomedical Engineering, Value Stream Mapping
Education
Indiana Wesleyan University 2009 — 2012
Master of Business Administration (MBA), Applied Management
University of Victoria 1990 — 1995
Bachelor, Mechanical Engineering (Co-op Program)
Validant 2013 - Present
The Quantic Group Ltd. November 2011 - February 2013
Genzyme 2011 - 2013
The Quantic Group 2011 - 2013
Celgene Corporation November 2007 - June 2011
Watson Pharmaceuticals March 2003 - November 2007
Wyeth 1999 - 2003
Baxter International Inc. 1999 - 2003
Marsam Pharmaceuticals, Cherry Hill, NJ 1999 - 1999
Molecular Biosystems, Inc., San Diego, CA 1997 - 1998
Skills
Technology Transfer, Cleaning Validation, Project Management, GMP, GxP, Sop, 21 CFR Part 11, Validation, Computer System..., Aseptic Processing, GAMP, Biopharmaceuticals, Biotechnology, CAPA, LIMS, GLP, Lifesciences, Change Control, Process Validation, Remediation, V&V, Pharmaceutical Industry, Regulatory Requirements, SOP, Life Sciences, Quality Assurance, FDA
Education
Far Eastern University 1976 — 1979
Zoology
Far Eastern University 1976 — 1979
University of Santo Tomas 1974 — 1976
General
Saint Louis University (PH) 1970 — 1974
Saint Louis University (PH) 1970 — 1974
Validant February 2014 - Present
Validant January 2013 - January 2014
Validant March 2009 - December 2012
Special Devices, Inc. March 2008 - December 2008
The Tech Group May 2006 - February 2008
CR Bard June 2001 - May 2006
Skills
FDA, FMEA, Lean Manufacturing, Manufacturing, Six Sigma, Quality Control, Validation, Quality System, 5S, Process Improvement, CAPA, V&V, ISO 13485, Design of Experiments, GMP, Medical Devices, SPC, Design Control, R&D, Manufacturing..., Value Stream Mapping, Injection Molding
Education
SM Solutions 2010 — 2010
Certificate, Process Optimization via Scientific Molding
University of Phoenix 2005 — 2007
MBA, Business Administration, Management and Operations
AAMI 2005 — 2005
Certificate, Software Validation Requirements and Industry Practice
R. Michael Donovan & Co., Inc. 2005 — 2005
Certificate, Lean Master Training
Arizona State University 2004 — 2005
Certificate, Industrial Statistics with Emphasis on Six Sigma
Arizona State University 1997 — 2001
BS, Industrial Engineering
Colegio San Ignacio de Loyola 1992 — 1996
High School Diploma
Sharp Corporation February 2012 - Present
B2 Solutions LLC February 2009 - Present
RLM Consulting January 2002 - Present
USDM 2015 - 2015
Validant 2013 - 2013
Validant 2013 - 2013
Validant 2013 - 2013
Synthes 2011 - 2012
West Pharmaceutical Services 2011 - 2011
Morphotek, Inc. 2009 - 2009
Skills
Validation, Pharmaceutical Industry, FDA, GMP, Sop, Computer System..., Quality Assurance, Software Compliance
Education
computer learning center 1998 — 1999
Eastern Kentucky University 1977 — 1982
Fairleigh Dickinson University 1977 — 1982
Duquesne University 1978 — 1981
Drew University 1976 — 1980
The College of New Jersey 1976 — 1980
Rutgers University-New Brunswick 1975 — 1979
Ursinus College 1975 — 1978
Hammonton High School 1973 — 1977
QVM Services November 1993 - Present
Validant 2012 - 2013
CRB Engineering October 1992 - November 1993
Traid Technolgies 1991 - 1993
Triad Technologies / Jacobs Engineering August 1989 - October 1992
Praxis Biologics January 1986 - August 1989
Skyland Scientific 1988 - 1989
Bristol Myers Syracuse 1981 - 1986
Skills
Validation, Cleaning Validation, Pharmaceutical Industry, Aseptic Processing, FDA, HPLC, Biotechnology, Sop, Quality Control, Process Engineering, GMP, Technology Transfer, Quality Auditing, Biopharmaceuticals, Quality System, Vaccines, V&V, Manufacturing, Regulatory Affairs, Chemistry, Formulation, GLP, CAPA, Commissioning, 21 CFR Part 11, Change Control, Process Simulation, SOP
Education
Syracuse University 1982 — 1984
Graduate Studies, Chemistry
Clarkson University 1977 — 1981
Bachelor of Applied Science (B.A.Sc.), Chemistry
Validant November 2014 - Present
GE Healthcare March 2007 - December 2013
Abraxis BioScience November 2006 - March 2007
Abbott Laboratories July 2004 - November 2006
Sara Lee July 2001 - July 2004
Skills
CAPA, Medical Devices, FDA, Quality System, Pharmaceutical Industry, Quality Assurance, Regulatory Affairs, ISO 13485, Process Improvement, Validation
Education
Ilinois State
Keller Graduate School of Management of DeVry University 2004 — 2006
MBA & MHRM
Xavier University of Louisiana 1997 — 1999
Chicago State University
BS
Whitney M. Young Magnet HS
Boehringer Ingelheim January 2015 - Present
DPT October 2013 - Present
Validant December 2012 - August 2013
Integra LifeSciences December 2012 - August 2013
Novartis Consumer Health March 1998 - December 2012
Skills
Change Control, 21 CFR Part 11, Quality Assurance, CAPA, GxP, Document Management, Deviations, FDA, GMP, Complaint Management, Computer System..., Training, Quality Auditing, V&V, cGMP practices, Records Management, Complaint Investigations, Gap Analysis, TrackWise
Education
Bellevue University 2002 — 2004
BS, Business Information Systems
Validant June 2012 - Present
Pharma Tech Industries May 2011 - Present
Morton Grove Pharmaceuticals November 2010 - May 2011
Validant June 2010 - October 2010
ANI Pharmaceuticals, Inc. 2008 - 2009
Elan 2002 - 2007
Skills
Analytical Chemistry, Quality Assurance, GLP, GMP, Sop, FDA, Validation, Quality System, Change Control, 21 CFR Part 11, CAPA, Computer System..., V&V, GxP, Regulatory Affairs
Education
Maryville University of Saint Louis 1984 — 1988
B.S., Information Systems / Management
University of Missouri-Columbia
Goode Compliance International June 2014 - Present
Validant April 2014 - June 2014
Oxford Global Resources September 2012 - March 2014
Goode Compliance International 2014 - 2014
Goode Compliance International 2014 - 2014
Validant January 2012 - May 2012
Watson Pharmaceuticals 2006 - 2011
Nabi Biopharmaceuticals 1998 - 2006
Skills
CAPA, FDA, Change Control, V&V, GMP, Validation, Sop, 21 CFR Part 11, Cleaning Validation, Pharmaceutical Industry, Quality System, Regulatory Affairs, Aseptic Processing, Computer System..., GLP, Quality Assurance, LIMS, Quality Control, Biopharmaceuticals, ISO 13485, GxP, Design Control, Medical Devices, Quality Auditing, Technology Transfer, GAMP, Pharmaceutics, Biotechnology, Trackwise, ISO 14971, Regulatory Requirements, Regulatory Submissions, FDA GMP, Analytical Chemistry, Chromatography, Calibration, Formulation, Contract Manufacturing, UV/Vis, Equipment Qualification, HPLC, R&D, Process Simulation, Root Cause Analysis, GCP, Drug Development, Chemistry, Lifesciences, Quality by Design, Dissolution
Education
Ferris State University 1971 — 1975
Associates, Industrial Chemistry Technology
Florida Atlantic University
Bachelor, Chemistry
XenoPort, Inc. September 2015 - Present
Validant November 2013 - September 2015
Real Staffing July 2013 - November 2013
Mosaic June 2012 - October 2012
Boehringer Ingelheim (Formerly Amgen Fremont) March 2011 - November 2011
Amgen June 2005 - March 2011
Johnson & Johnson October 2004 - March 2005
LICENSE INSTRUCTION SCHOOLS March 2004 - October 2004
PACIFIC NATIONAL REALTORS October 2002 - October 2004
FREMONT SCHOOL September 2000 - March 2002
Skills
Presentation Coaching, Training Program..., Development of Training..., Performance Analysis, Learning Management, Training Delivery, Instructional Design, Instructor-led Training, GMP, Training, Quality Assurance, Sop, Employee Training, Software Documentation, Cross-functional Team..., E-Learning, FDA, Learning Management..., Management, Needs Analysis, Program Management, Quality System, SharePoint, Human Resources, Process Improvement, Strategy, Project Management, Pharmaceutical Industry, Change Control, Biotechnology, Validation, CAPA, Biopharmaceuticals, 21 CFR Part 11, SOP
Education
California State University-Sacramento 1999 — 2002
Masters of Arts, English
University of California, Davis 1991 — 1995
Bachelors of Arts, English
Validant May 2012 - Present
Lab Support - A Division of On Assignment 2007 - 2012
Aerotek Professional Services 2005 - 2007
M.S. Promotions, Inc. 2000 - 2005
Skills
Validation, FDA, Biotechnology, Quality Assurance, Staffing Services, R&D, Regulatory Affairs, Medical Devices, Research, Technical Recruiting, Sop, Pharmaceutical Industry, Chemistry, Manufacturing, Recruiting, GLP, Quality Control, Leadership, Quality System, Pharmaceutics, Internet Recruiting, Strategy, Management, GMP, Lifesciences, Executive Search, Talent Acquisition, Contract Recruitment, Laboratory, Temporary Placement, Applicant Tracking..., College Recruiting, Screening Resumes, Benefits Negotiation, Permanent Placement, Sourcing, Onboarding, Temporary Staffing, Hiring, Screening, Interviews, Consulting, Training, Human Resources, Cross-functional Team..., Talent Management, Mentoring, SOP
Education
Bowling Green State University 1998 — 2000
Bachelor of Science
Bowling Green State University
FDA January 2014 - Present
Validant November 2011 - February 2012
Dendreon December 2010 - December 2011
CIBA VISION May 2010 - December 2010
Biogen Idec September 2007 - September 2009
Amgen April 2005 - July 2007
Abbott Laboratories 2002 - 2005
Wyeth 2001 - 2002
Cardinal Health 1999 - 2001
Skills
Technology Transfer, Quality Management, Oracle SQL, cGMP, CAPA, GMP, SPC, FDA, Sop, V&V, Validation, Medical Devices, Quality Assurance, GxP, Pharmaceutics, Quality Auditing, Quality System, Contract Manufacturing, Quality Control, Biotechnology, Trackwise, 21 CFR Part 11, Lean Manufacturing, Cross-functional Team..., HPLC, Manufacturing, Aseptic Processing, IND, Microbiology, Continuous Improvement, Laboratory, Change Control, Calibration, GLP, Minitab, Regulatory Submissions, Pharmaceutical Industry, Software Documentation, SOP, TrackWise
Education
Alabama State University 1994 — 1997
M.S., Microbiology- Immunology
Medical College of Georgia School of Medicine 1989 — 1994
Studied toward MD, Medicine
Paine College 1985 — 1989
B.S., Biology-Chemistry
Harvard University 1987 — 1987
Studied undergraduate Neuroscience, Pre-Med
Genentech March 2013 - Present
Validant October 2011 - March 2013
Genentech July 2010 - April 2011
Genentech January 2008 - July 2010
Genentech August 2006 - January 2008
Genentech March 2001 - August 2006
Genentech October 1999 - March 2001
Genentech June 1997 - October 1999
Genentech July 1996 - July 1997
Genentech September 1995 - July 1996
Skills
GMP, Biopharmaceuticals, HPLC, FDA, Chromatography, Sop
Education
California State University-Sacramento 2006 — 2008
MBA, Business
University of California, Davis 1988 — 1994
BS, Biological Sciences
DynPort Vaccine Company LLC, A CSC Company 2014 - Present
Ascendia Pharmaceuticals LLC 2014 - Present
Consultant 2011 - Present
Piramal Critical Care 2012 - 2014
Validant 2011 - 2012
Celator Pharmaceuticals November 2005 - September 2011
Chiron Corporation January 2003 - November 2005
RCM Technologies December 2002 - December 2003
Stryker December 2000 - December 2002
Duramed Pharmaceuticals December 1998 - December 2000
Skills
Biotechnology, CAPA, GLP, GMP, HPLC, Quality Assurance, Validation, V, Sop, Quality Control, Leadership, Pharmaceutical Industry, FDA, Technology Transfer, Medical Devices, SOP, Quality System
Education
Stevens Institute of Technology 1978 — 1986
Ph.D.
LIU Brooklyn 1974 — 1978
MS
City University of New York City College 1969 — 1973
BS
Clinical Consultant August 2010 - Present
Validant May 2010 - August 2010
Fenwal, Inc. September 2009 - May 2010
GE Healthcare June 2008 - August 2009
Hospira August 2004 - June 2008
Baxter Healthcare Corporation June 2001 - August 2004
Baxter Transfusion Therapies January 1995 - June 2001
Skills
Medical Devices, QSR, Pharmacovigilance, Regulatory Documentation, Lessons Learned, Governmental Compliance, Medical Device Product..., Autoimmune Diseases, Regulated Industries, Complaint Handling, Patient Safety, Remediation, ISO 13485, Documentation, MedWatch, 21 CFR 803, 21 CFR 820, apheresis, cellular therapy, phlebotomy, hematology, 483 remediation, Opthalmics, ISO 14971, Post Market Surveillance, Vigilance, Quality System..., 21 CFR, Class III Medical..., Class II, Class I, MDR, Part 820, FDA GMP, Medical Device Directive, Conformity Assessment, Combination Products, Cardiovascular Devices, Clinical Cardiology, Transfusion Medicine, Blood Products, Stem Cell Transplant, Cell Therapy, Blood Typing, Hematocrit, Drawing Blood, Trach Care, Central Lines, MedDRA, Adverse Event Reporting
Education
College of Lake County
ADN, Registered Nurse
College of Lake County
Associate, Nursing
Leidos October 2010 - Present
Validant June 2010 - September 2010
Osiris Therapeutics November 2008 - June 2009
Actavis September 2006 - October 2008
Actavis (previously Alpharma) September 2006 - October 2008
Actavis October 2005 - November 2006
Skills
GMP, FDA, Quality System, Change Control, Sop, 21 CFR Part 11, LIMS, Quality Assurance, Pharmaceutical Industry, CAPA, Analytical Chemistry, Biotechnology, Computer System..., Document Management, GLP, HPLC, Laboratory, Lifesciences, Pharmaceutics, Quality Auditing, Quality Control, Quality Management, Regulatory Affairs, Root Cause Analysis
Education
Aquinas College 1997 — 2000
BS, Biology
Saint Joseph's University 1989 — 1993
BS, Psychology
Validant January 2015 - Present
Validant October 2012 - December 2014
Thermo Fisher Scientific May 2010 - September 2012
Thermo Fisher Scientific May 2009 - May 2010
Thermo Fisher Scientific September 2006 - May 2010
Thermo Fisher Scientific September 1998 - September 2006
Skills
Cross-functional Team..., Product Management, Lifesciences, Product Marketing, Product Development, Field Service, Process Improvement, Product Launch, Product Lifecycle..., Competitive Analysis, Strategic Planning, Pricing, Management, Enterprise Software, Medical Devices, Biotechnology, Validation, Strategy, Program Management, New Business Development, Marketing Strategy, Sales Management, Market Development, Customer Satisfaction, Marketing, FDA, Commercialization, Pharmaceutical Industry, Hardware Diagnostics
Education
Bentley College - Elkin B. McCallum Graduate School of Business 1999 — 2002
Master of Business Administration (MBA), Marketing
Boston University 1992 — 1996
Bachelor's degree, Biomedical/Medical Engineering
Halyard Healthcare October 2014 - Present
Validant July 2014 - October 2014
CVC Consulting September 2012 - June 2014
The Quantic Group April 2011 - August 2012
Botanical Laboratories December 2008 - April 2011
Leiner health Products February 2008 - October 2008
Sandoz April 2003 - January 2008
DSM Pharmaceuticals 1998 - 2003
Alpharma 1993 - 1998
Shering-Plough 1991 - 1993
Skills
Statistics, Agronomy, Cereal Chemistry, Compliance Management, Quality Engineering, Quality Assurance, Quality Auditing, Quality Systems, Quality System, Quality Control, Validation, FDA, Regulatory Affairs, Pharmaceutical Industry, Cleaning Validation, Change Control, 21 CFR Part 11, Sop, CAPA, V&V, GMP, Supplier Quality..., Project Management, Statistical Modeling
Education
North Dakota State University 1980 — 1984
Agonomy/Statistics
Pennsylvania State University-Erie Campus 1973 — 1980
BS, Biology, Genetics
AbbVie November 2013 - December 2014
Validant February 2012 - August 2012
Abbott Diagnostics 2000 - November 2009
Abbott Diagnostics 2000 - 2008
Abbott Laboratories January 1999 - January 2004
Abbott Laboratories January 1996 - January 1999
Abbott Laboratories January 1994 - January 1996
Abbott Laboratories January 1992 - January 1994
Abbott Laboratories January 1991 - January 1992
Abbott Laboratories January 1989 - January 1991
Skills
CAPA, Design Control, FDA, Change Control, ISO 13485, Quality System, Medical Devices, V&V, Validation, GMP, 21 CFR Part 11, Quality Assurance, Cross-functional Team..., Software Documentation, Sop, Pharmaceutical Industry, Lifesciences, Laboratory, Microbiology, Quality Control, Regulatory Affairs, SOP
Education
Chicago Medical School at Rosalind Franklin U-Med & Science 1990 — 1991
M.S. Cllinical Laboratory Technology, Laboratory Science, Lab Administration
ASQ, AAMI, RAP 1994 — 2003
Certifications, Quality Systems Regulations
Dominican College 1966 — 1970
Bachelor of Science, Medical Technology
PPD June 2013 - Present
Validant June 2010 - June 2013
Navigant Capital Advisors June 2006 - June 2010
Jacobs Capital January 2005 - April 2006
Broadbay Networks August 1999 - April 2002
Skills
Valuation, Accounting, Financial Analysis, Financial Reporting, Financial Modeling, Business Strategy, Business Development, Investment Banking, Private Equity, Debt, Debt Restructuring, Mergers, Acquisitions, FDA, Mergers & Acquisitions, Due Diligence
Education
Emory University - Goizueta Business School
MBA, Finance and Accounting
The Johns Hopkins University
MS, Biotechnology
Vanderbilt University
The Westminster Schools
Cambridge Major Laboratories, Inc. August 2014 - February 2015
Patheon Manufacturing Services formerly DSM Pharmaceuticals, Greenville, NC July 2011 - August 2014
Oxford International February 2011 - June 2011
Validant June 2010 - January 2011
GE Healthcare 2007 - 2009
Cardinal Health March 2006 - March 2007
Abbott Laboratories / Hospira Inc. 2004 - 2006
Abbott Laboratories 2000 - 2004
Skills
CAPA, Change Control, FDA, Project Management, 21 CFR Part 11, Internal Audit, Quality Assurance, GMP, Auditing, ISO, ISO 13485, Medical Devices, Pharmaceutical Industry, Quality Control, Root Cause Analysis, Quality System, Quality Auditing
Education
Elizabeth City State University
BS, CHEMISTRY
Pharma Tech Industries June 2013 - April 2015
Validant March 2013 - May 2013
Pall Corporation July 2010 - January 2013
Boehringer Ingelheim August 2009 - July 2010
Boehringer Ingelheim July 2008 - July 2009
Boehringer Ingelheim November 2007 - July 2008
Boehringer Ingelheim January 2006 - November 2007
Merck August 2003 - September 2005
Merck August 1999 - August 2003
Merck June 1993 - August 1999
Skills
Validation, Change Control, Quality System, Quality Assurance, GMP, CAPA, 21 CFR Part 11, FDA, Sop, Cleaning Validation, GxP, Pharmaceutical Industry, Trackwise, LIMS, GLP, Quality Auditing, FDA GMP, Vaccines, Pharmaceutics, Technology Transfer, cGMP practices, Deviation Management, Analytical Chemistry, Chromatography, Regulatory Affairs, Biopharmaceuticals, Contract Manufacturing, Deviations, Quality Management, HPLC, GAMP, ISO 13485, Root Cause Analysis, Quality Control, Regulatory Requirements, Auditing, ISO, Supplier Quality, Equipment Qualification, Raw Materials, cGMP manufacturing, Iso 9000, USP, Pharmaceutical..., Batch Release, NDA, Manufacturing Operations, Thrive in A Fast-paced..., Enjoy Challenges, Cross-functional Team...
Education
Georgia Institute of Technology 1987 — 1989
N/A, Analytical Chemistry
Indiana University of Pennsylvania 1984 — 1987
MS, Analytical Chemistry
St. Xavier's College 1980 — 1983
B.Sc., 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
Stratus and Associates April 2007 - Present
Validant 2013 - 2015
Validant 2013 - 2015
Abbott Medical Optics July 2007 - October 2012
Syngenta July 2004 - January 2007
Syngenta June 1995 - July 2004
Syngenta 1992 - 1995
Quality Associates, Inc. June 1986 - December 1991
Bayer CropScience September 1984 - September 1986
Bowman Gray School of Medicine 1983 - 1984
Skills
Product Development, Project Management, Portfolio Management, Global Management, Document Management, Stage-Gate, Design Control, Cross-functional Team..., Biotechnology, R&D, Medical Devices, Market Development, GMP, Regulatory Affairs, Validation, GLP, FDA, Quality Assurance
Education
University of North Carolina at Greensboro 1989 — 1992
Master Science - Chemistry, Organic Chemistry, Pesticide Worker Exposure
Guilford College 1979 — 1983
Bachelor in Science, Chemistry, Math, and Geology
Chatham High School
Philips Healthcare September 2014 - Present
Covidien July 2014 - September 2014
Lighthouse Placement Services, LLC February 2014 - July 2014
Insulet Corporation October 2013 - February 2014
Validant 2013 - 2013
NxStage Medical, Inc. 2007 - 2012
Philips Medical Systems January 2003 - February 2007
Philips Medical Systems February 2002 - January 2003
Axsun Technologies December 2000 - July 2001
ACT Manufacturing, Inc. April 1997 - September 2000
Skills
Quality Assurance, Quality System, FDA, Medical Devices, ISO 13485, ISO, GMP, Quality Auditing, Change Control, Quality Control, CAPA, Internal Audit, Cross-functional Team..., Quality Management, Complaint Management, Sop, TrackWise, Oracle Agile PLM, Salesforce.com
Education
Middlesex Community College
Durata Therapeutics May 2014 - Present
Alexion Pharmaceuticals October 2012 - December 2013
Validant October 2011 - October 2012
Novo Nordisk Inc. January 2001 - November 2010
Pfizer Pharmaceuticals August 1999 - December 2000
Aventis Behring (now CSL Behring) November 1996 - August 1999
Cephalon (now Teva) November 1994 - November 1996
Sanofi (Formerly Sterling) 1991 - 1995
Skills
21 CFR Part 11, FDA, GxP, Pharmaceutical Industry, Sop, GMP, Risk Management, Quality Systems Design, Compliance..., GCP, Quality Auditing, Quality Management, Aseptic Processing, CAPA, Biopharmaceuticals, V&V, Regulatory Requirements, Validation, Biotechnology, Quality System, Computer System..., Quality Control, Trackwise, Six Sigma, Quality Assurance, Change Control, Lifesciences, GAMP, GLP, Technology Transfer, Regulatory Affairs, Regulatory Submissions, ISO 13485, Pharmaceutics, Cleaning Validation, Clinical Trials, Medical Devices, Cross-functional Team..., R&D, Clinical Development, CRO, FDA GMP, Vaccines, Pharmacovigilance, Drug Development, SOP, Life Sciences, Process Improvement
Education
Villanova University
Master of Science, Information Science
Chestnut Hill College
BS, Biological Sciences
Validant August 2015 - Present
Validant November 2014 - July 2015
Validant January 2012 - October 2014
Radiopharmaceuticals Company June 2006 - September 2011
Valspec September 2004 - August 2006
Emerson July 2002 - July 2003
Monsanto November 1997 - January 2000
Monsanto November 1993 - November 1997
Monsanto November 1992 - November 1993
Monsanto July 1980 - October 1992
Skills
GMP, SAP, CAPA, Sop, Quality System, Quality Assurance, Pharmaceutical Industry, Change Control, FDA, Quality Control, Root Cause Analysis, Computer System..., Biopharmaceuticals, Validation, 21 CFR Part 11, Lifesciences, GxP, V, LIMS, Life Sciences, SOP
Education
Lindenwood University
MBA
University of Wisconsin-Madison
BS
Gilead Sciences November 2013 - Present
Pacific Medical Device January 2010 - Present
Validant August 2012 - October 2013
Medlogics DC March 2005 - August 2010
Medlogics Device Corporation March 2005 - August 2010
Medlogics Device Corporation June 2005 - May 2010
Pacific Analytical Laboratory March 2004 - July 2008
Cerus corporation 2001 - 2004
Cerus Corporation July 2000 - January 2003
Bayer January 2000 - May 2000
Skills
Biotechnology, GMP, Clinical Development, GLP, Regulatory Submissions, FDA, Drug Development, HPLC, Medical Devices, Regulatory Affairs, Analytical Chemistry, Lifesciences, Validation, Chromatography, Technology Transfer
Education
University of California, Davis 1985 — 1987
Post, Research
California State University-Fresno 1979 — 1982
MS, Chemistry
The National University 1970 — 1974
BS, Chemistry
GSK April 2015 - Present
DePuy Synthes September 2013 - April 2015
Validant March 2013 - July 2013
PL Developments September 2011 - March 2013
Watson Pharmaceuticals May 2008 - June 2011
Watson Pharmaceuticals August 2007 - May 2008
Andrx Pharmaceuticals April 2004 - August 2007
Andrx Pharmaceuticals 2003 - 2004
Andrx Pharmaceuticals 2002 - 2003
Andrx Pharmaceuticals 2001 - 2002
Skills
Quality Assurance, CAPA, Document Management, GMP, Change Control, Validation, Technical Writing, FDA, Internal Audit, SOP development, Oracle Agile PLM, Oracle E-Business Suite, Trackwise, JDE Enterprise One, QUMAS, Livelink, Microsoft Office, Root Cause Analysis, Operational Excellence, Team Leadership, Deviations Investigation, Performance Management, Key Performance..., Solid Oral Dosage Forms, FMEA, Lean Manufacturing, Manufacturing..., Quality System, Manufacturing, Sop, GLP, Pharmaceutics, V&V, Cleaning Validation, 21 CFR Part 11, GxP, LIMS, Quality Auditing, Aseptic Processing, Biopharmaceuticals, Computer System..., ISO 13485, Regulatory Affairs, Medical Devices, Pharmaceutical Industry, Technology Transfer, Regulatory Submissions, Software Documentation, Deviations, Regulatory Requirements
Education
Broward Community College 2004 — 2006
AA, Accounting & Business Administration, 3.0
Black Diamond Networks April 2014 - June 2014
Black Diamond Networks October 2013 - March 2014
Validant July 2013 - October 2013
Black Diamond Networks August 2012 - June 2013
Oxford International May 2011 - July 2012
Innovations Consulting Group, LLC February 2007 - March 2011
Maetrics, LLC September 2005 - January 2007
Skills
Quality Assurance, Employee Training, Risk Management, FDA, ISO 13485, Quality System, Validation, Software Documentation, Sop, Team Building, Program Management, Manufacturing..., CAPA, Team Leadership, Quality Control, Cross-functional Team..., Medical Devices, Clinical Trials, Six Sigma, Quality Management, Process Simulation, Biotechnology, Process Improvement, Regulatory Affairs, Quality Auditing, Lifesciences, Lean Manufacturing, Iso 9000, GMP, FMEA, Testing, Document Management, Pharmaceutical Industry, Clinical Development, Management, Product Development, R&D, Root Cause Analysis, Manufacturing, ISO, Technology Transfer, Operational Excellence, Change Management, SPC, Product Launch, Business Process..., Value Stream Mapping, Kaizen, Training, Strategic Planning
Education
Northeastern University 2012 — 2016
Master of Science (M.S.), Regulatory Affairs for Drugs, Biologics and Medical Devices
Marian University 1998 — 2000
Bachelor of Science (B.S.), Biology and Chemistry
Regulatory Compliance Associates, Inc. May 2013 - Present
Abbott Laboratories March 2003 - April 2012
Regulatoy Compliance Associates 2012 - 2012
Validant 2012 - 2012
Abbott Laboratories March 2003 - March 2009
Abbott Diagnostic Division January 1997 - March 2003
Abbott Diagnostics 1986 - 2000
Abbott Laboratories 1992 - 1997
Abbott Laboratories 1990 - 1992
Condell Memorial Hospital August 1977 - March 1986
Skills
CAPA, Complaint Handling, Medical Device Design..., Documentation, Document Management, Pharma GMP, Quality System..., Risk Management, Process Improvement, Process Mapping, Certified Quality..., Project Management, Training & Development, Mentoring, Performance Metrics, Visio, Minitab, Lean Six Sigma Black..., Change Control, ISO standards, ICH, Quality System, Business Process Mapping, Pharmaceutical Industry, Medical Devices, FDA, GLP, Software Documentation, Six Sigma, Complaint Management, ISO, GMP
Education
Lake Forest Graduate School of Management 1988 — 1991
MBA
DePaul University 1968 — 1972
BS, Medical Technology
ONMedical August 2015 - Present
QCS North America June 2013 - June 2015
Validant January 2013 - May 2013
Tunnell Consulting, Inc. April 2012 - December 2012
Beckman Coulter September 2006 - December 2011
Schering-Plough Research Institute September 2001 - September 2006
The University of Iowa August 1998 - September 2002
Schering-Plough Research Institute August 1996 - August 1998
Skills
Lean Manufacturing..., Problem Solving, Manufacturing Operations, Quality Systems, cGMP Change Control..., 5S, Facility Operations, GMP, Process Improvement, Lean Manufacturing, Six Sigma, Change Control, Value Stream Mapping, Manufacturing, Kaizen, Industrial Engineering, Medical Devices, Toyota Production System, Continuous Improvement, Kanban, Validation, ISO, Quality System, Sop, Quality Control, FDA, Technology Transfer, V&V, ISO 13485, Root Cause Analysis, Software Documentation, DMAIC, Quality Auditing, Pharmaceutical Industry, Minitab, Testing, Design Control, SOP
Education
New Jersey Institute of Technology 1986 — 1992
IE, Production and Manufacturing
Teterboro School of Aeronautics 1988 — 1990
Aviation Technology A&P FAA, Aircraft Airframe and Power Plant Certification
Oxford Global Resources April 2014 - Present
Validant July 2013 - Present
Spectranetics September 2010 - July 2013
Oxford Global Resources September 2008 - April 2011
Shire Human Genetic Therapies 2008 - 2010
Regulatory Compliance Associates, Inc 2009 - 2009
Teleflex Medical June 2006 - March 2008
Angiotech 2008 - 2008
GSK 1998 - 2006
Skills
21 CFR Part 11, Computer System..., SAP, Quality System, Change Management, ERP, Software Quality..., Test Management, System Testing, Validation, Quality Assurance, FDA, Sop, Change Control, PMP, GMP, GxP, Testing, Software Documentation, GAMP, CAPA, ISO 13485, Quality Management, Quality Auditing, V&V, LIMS, Quality Control, GLP, Medical Devices, Regulatory Requirements, Regulatory Affairs, ISO, Process Simulation, Document Management, Root Cause Analysis, SOP
Education
Colorado Christian University 1991 — 1994
BS, Organizational Management
Validant March 2014 - Present
Johnson & Johnson - McNeil Consumer Healthcare January 2012 - July 2013
Johnson & Johnson - Group of Consumer Companies July 2010 - December 2011
Johnson & Johnson - Group of Consumer Companies October 2008 - May 2010
Johnson & Johnson - Group of Consumer Companies March 2007 - September 2008
Johnson & Johnson - Group of Consumer Companies March 2006 - March 2007
Johnson & Johnson - Group of Consumer Companies March 2002 - March 2006
Johnson & Johnson Group of Consumer Companies November 1997 - March 2002
Johnson & Johnson - Group of Consumer Companies November 1991 - May 1997
Johnson & Johnson - Group of Consumer Companies April 1974 - May 1984
Skills
Operations Management, Change Management, Cross-functional Team..., Succession Planning, Strategic Planning, Sales Operations, Strategy, Process Improvement, Sales, Competitive Analysis, Supply Chain, Forecasting, Leadership, Procurement, Supply Chain Management
Education
Duquesne University
BA, English
W. L. Gore & Associates April 2011 - April 2014
Validant March 2010 - November 2010
Pathwise, Inc April 2009 - August 2009
Amgen May 1997 - April 2007
Bausch & Lomb September 1995 - April 1997
Ethicon Endo-Surgery October 1991 - September 1995
Abbott Laboratories October 1988 - October 1991
Federal Reserve Bank March 1988 - October 1988
Quest Medical March 1983 - March 1988
Skills
Quality Systems, Supplier Quality, GMP, Quality Management, Medical Devices, Biotechnology, cGMP, Quality Auditing, SOP, Quality Assurance, ISO 13485, ISO, Auditing, Compliance, Change Control, Risk Management, Packaging, Supply Chain Management, resin, Vendor Relations, Strategic Sourcing, Quality System, Process Improvement, Sop, Manufacturing, Lean Manufacturing, Validation, FDA, Design Control, Resin, CAPA, Supply Chain, Iso 9000, Root Cause Analysis, Biopharmaceuticals
Education
Grove City College 1978 — 1982
B.S., Management Engineering
Validant January 2014 - Present
Rhino's Special Ears 2010 - Present
American Medical Systems 2006 - 2009
Microsulis 2006 - 2007
Microsulis 2005 - 2007
CW Bill Young Department of Defense Marrow Donor Program January 1995 - January 2005
US Navy 1988 - 1998
Skills
Post market Clinical..., Medical Device and..., Lieutenant Commander US..., Critical Care Medicine, Published Author, Medical Devices, Healthcare, Surgery, Capital Equipment, Hospitals, Clinical Research, Cardiology, Training, Operating Room, Management, Surgeons, Nursing
Education
Jacksonville University 1993 — 1995
BSN, Nursing
Saint Anthony School of Nursing 1975 — 1978
Nursing, Nursing
Burlington Central High School 1972 — 1975
High School
Validant April 2015 - Present
Synthes October 2012 - February 2015
Blanchard Laboratories August 2012 - September 2012
Zimmer Surgical July 2011 - July 2012
Zimmer Surgical January 2011 - June 2011
GE Healthcare January 2007 - December 2010
Aerotek Scientific/Baxter Healthcare Corporation September 2005 - December 2006
Abbott Diabetes Care January 2003 - January 2005
Abbott Diabetes Care January 2001 - January 2003
Abbott Diabetes Care January 1997 - January 2001
Skills
CAPA, Quality System, Quality Control, Management, Software Documentation, Project Management, ISO 13485, Quality Assurance, FDA, Data Analysis, Medical Devices, Leadership, Cross-functional Team..., Validation, Quality Management, Process Improvement, MDR, Regulatory Affairs, Six Sigma, Root Cause Analysis, Regulatory Requirements, Process Engineering, ISO 14971, Manufacturing, Complaint Management, V&V, GMP, 21 CFR Part 11, Design Control, R&D, Change Control, Lean Manufacturing, 21 CFR
Education
Emmanuel College
Bachelor of Science, Business Administration
Consulate General of Canada in Chicago March 2014 - Present
College Track September 2013 - March 2014
San Francisco Board of Supervisors September 2013 - March 2014
California State Assembly September 2013 - December 2013
YWCA Greater Charleston August 2012 - August 2013
SF Restaurant June 2003 - August 2012
Validant November 2011 - March 2012
Campaign for San Francisco Mayor June 2011 - November 2011
Common Sense Media June 2011 - August 2011
Einstein Noah Restaurant Group, Inc. June 2007 - August 2007
Skills
Non-profit Program..., Community Outreach, Cold Calling, Cultural Diversity, Editing, Fundraising, FDA, Program Management, Policy, Research, Recruiting, CRM, Leadership, Budgets, Event Planning, Public Speaking, Nonprofits, Social Media, Event Management, Policy Analysis
Education
McGill University
Bachelor of Arts & Science, Biomedical Sciences, Political Science, Canadian Ethnic and Racial Studies
National University of Singapore
Independent exchange, New Media
UC Berkeley
Independent exchange, Immigration Politics, Physics
Lowell High School
Validant March 2015 - Present
Johnson & Johnson December 2012 - December 2014
Lorillard Co. February 2012 - December 2012
Genilogix August 2005 - April 2010
American Air Liquide 2002 - 2004
Skills
Test Management, Requirements Analysis, Test Writing, Defect Tracking, SDLC, User Acceptance Testing, Application Lifecycle..., Quality Center, QTP, Performance Testing, Load Testing, Quality Assurance, Software Quality..., Testing, Software Documentation, 21 CFR Part 11, Business Analysis, Project Management, HP Quality Center, Computer System..., Validation, Pharmaceutical Industry, Change Control, Process Improvement, Management
Education
Goldey Beacom College 1998 — 2000
BS, Computer Information Systems, 3.8
The Culinary Institute of America 1992 — 1994
Associate of Arts (AA), Culinary Arts/Chef Training
University of Delaware 1989 — 1991
N/A, English Language and Literature, General
NSF October 2014 - Present
Validant March 2013 - December 2013
Novartis Consumer Health January 2012 - October 2012
Sandoz, Austria November 2011 - December 2011
Sandoz, B August 2011 - November 2011
NNE Pharmaplan June 2010 - May 2011
Bayer HealthCare October 2004 - October 2009
Bayer HealthCare July 2003 - September 2004
Bayer HealthCare January 2002 - June 2003
Bayer HealthCare January 1992 - December 2001
Skills
Change Control, GLP, Sop, Data Analysis, Biotechnology, Aseptic Processing, Quality Control, Auditing, Quality Management, Validation, Biopharmaceuticals, Technology Transfer, FDA, Inspection, Continuous Improvement, GMP, Software Documentation, Root Cause Analysis, CAPA, Laboratory, Quality System, Manufacturing, ISO 13485, Medical Devices, Assay Development, GAMP, Regulatory Requirements, Lifesciences, Management, Biochemistry, Quality Assurance, Testing, GCP, LIMS, Cross-functional Team..., Pharmacovigilance, Vaccines, ELISA, GxP, Regulatory Submissions, Six Sigma, Cleaning Validation, 21 CFR Part 11, Training, Pharmaceutical Industry, Quality Auditing, ISO, Internal Audit, Lean Manufacturing, Process Improvement
Education
Gujarat University 1971 — 1975
Bachelor of Science, Microbiology
Terumo Cardiovascular Systems April 2015 - Present
Quality/ Regulatory Independent Consultant, CQA, SSGB, Remediation SME August 2014 - Present
Validant 2013 - September 2014
Heartware 2014 - 2014
Terumo Cardiovascular Systems February 2011 - August 2013
Terumo Cardiovascular Systems October 2008 - March 2012
Trinity Health Systems, Info Systems June 2006 - October 2008
Instrumentation Laboratory December 1998 - 2004
Skills
ISO 13485, Quality System, CAPA, FDA, Design Control, V&V, Medical Devices, ISO 14971, Validation, GMP, 21 CFR Part 11, Quality Assurance, FMEA, Auditing, Quality Control, Root Cause Analysis, Six Sigma, SPC, ISO, Quality Auditing, Supplier Quality, Quality Management, 21 CFR, CQE, DMAIC, Change Control, Minitab, CQA, FDA GMP, Computer System..., Sop, Iso 9000
Education
Ferris State University 1979 — 1981
MLT(ASCP), BS(HCA), Health Care Administration, Project Mgmt
Onsted High 1976 — 1979
Pharmaceutics International Inc. (Pii) October 2012 - Present
Validant January 2012 - November 2012
AAIPharma Services Corp. 2002 - 2012
DSM 2001 - 2002
Bausch & Lomb 1989 - 2001
Altana 1986 - 1989
E. R. Squibb and Sons 1978 - 1986
Becton Dickinson 1971 - 1978
Skills
Reviews, Quality Auditing, Regulatory Audits, Aseptic Processing, Validation, GMP, FDA, CAPA, Change Control, Quality System, V&V, GxP, 21 CFR Part 11, Quality Assurance, Manufacturing, Sop, Quality Control, GLP, Pharmaceutical Industry, Technology Transfer, Microbiology, SOP, Sterilization
Education
Seton Hall University
MS, Microbiology
Marist College
BA, Biology
MAETRICS May 2015 - Present
MAETRICS January 2015 - April 2015
MAETRICS June 2013 - December 2014
Validant April 2011 - May 2013
bioMerieux 2009 - 2010
bioMerieux December 2002 - December 2009
Medtronic Midas Rex 2000 - 2002
CR Bard 1998 - 2000
Skills
ISO 13485, Quality System, Medical Devices, Quality Assurance, Iso 9000, Software Documentation, FDA, Change Control, Quality Control, Process Improvement, CAPA, GMP, Technical Writing, Root Cause Analysis, ISO, Document Management, Validation, Design Control, Engineering, V&V, ISO 9000
Education
Montreat College 1997 — 1999
MBA, Business Administration and Management, General
Clemson University 1981 — 1986
BS, Mechanical Engineering
Validant May 2015 - Present
Validant June 2014 - April 2015
Validant 2013 - June 2014
Aprecia Pharmaceuticals January 2011 - June 2012
Hoffmann-La Roche Inc. January 2000 - January 2011
Hoffmann-La Roche Inc. June 1986 - January 2000
Roche Vitamins June 1996 - August 1999
Skills
Microsoft Project, Microsoft Office, Project Management, Continuous Improvement, Budget, Troubleshooting, Operational Efficiency, Lean Manufacturing, Operational..., Manufacturing, MS Project, FDA, GMP, Quality Control, Leadership, Management, Pharmaceutical Industry, Sop, Pharmaceutics, Validation, CAPA, Technology Transfer, Regulatory Affairs, GLP, 21 CFR Part 11, LIMS, Change Control, Analytical Chemistry, Chromatography, HPLC, Formulation, Regulatory Submissions, Budgets
Education
Rutgers University 1992 — 1994
Master of Business Administration (MBA), Executive MBA
Fairleigh Dickinson University
Master of Science (MS), Chemistry
Maetrics Compliance and Quality Consulting August 2013 - Present
Validant April 2013 - July 2013
Parker Hannifin 2003 - March 2013
Nortel 2000 - 2002
Bespak plc 1995 - 1999
Becton Dickinson 1989 - 1995
Allen-Bradley 1981 - 1989
Skills
Design of Experiments, Manufacturing, Validation, Medical Devices, Quality Auditing, Process Engineering, Injection Molding, Electronics, Quality System, CAPA, ISO 13485, Supplier Quality, ISO, FDA, V&V, SPC, Root Cause Analysis, Quality Management, Six Sigma, GMP
Education
East Carolina University 1972 — 1976
BA, Biology
Frederick Military Academy 1970 — 1972
High School
Sunovion April 2015 - Present
Independant January 2000 - Present
Synageva BioPharma Corp. December 2013 - February 2015
Shire June 2013 - December 2013
Validant June 2012 - March 2013
Multiple 1991 - 2013
AMAG Pharmaceuticals June 2011 - May 2012
the Quality System Solution October 2009 - June 2011
Lonza Biologics October 2010 - April 2011
Skills
GMP, Quality System, Quality Assurance, Lifesciences, Change Control, Auditing, Validation, Sop, Protocol, CAPA, 21 CFR Part 11, FDA, GxP
Education
Lesley University
BA, English
Validant December 2014 - Present
Oxford Global Resources May 2014 - December 2014
Validant September 2012 - May 2014
G&W Laboratories September 2011 - August 2012
Smith Hanley Consulting Group August 2010 - September 2011
Celgene November 2008 - August 2010
Actavis September 2006 - November 2008
Schering-Plough Research Institute June 2003 - September 2006
Skills
CAPA, Sop, FDA, Pharmaceutical Industry, GMP, Validation, Quality Assurance, Regulatory Affairs, Regulatory Submissions, Software Documentation, Quality System, 21 CFR Part 11, Change Control, GCP, Clinical Trials
Education
Monmouth University 2001 — 2003
Bachelor of Science, Biology
Asbury Park
Asbury Park
Brookdale Community College
Associate of Science, Math and Science
Pfizer September 2015 - Present
Hospira June 2013 - September 2015
Validant February 2012 - September 2012
CorePharma LLC March 2011 - October 2011
Sandoz June 2009 - September 2010
Hospira June 2004 - June 2006
Bayer April 1997 - July 2001
Skills
Validation, V&V, Sop, Cleaning Validation, CAPA, FDA, 21 CFR Part 11, GxP, Biotechnology, Pharmaceutical Industry, Technology Transfer, Computer System..., Regulatory Affairs, Aseptic Processing, Pharmaceutics, Quality System, GLP, Deviations, Quality Assurance, Biopharmaceuticals, GAMP, Change Control, Manufacturing, Regulatory Requirements, LIMS, Quality Control, SOP development, ISO 13485, Quality Auditing, Regulatory Submissions, Medical Devices, FDA GMP, Calibration, Chromatography, cGMP practices, Lifesciences, Trackwise, Vaccines, Analytical Chemistry, Formulation, Sterilization, Drug Delivery, Microbiology, Pharmacovigilance, R&D, HPLC, Process Optimization, FMEA Risk Assessment, Internal & External..., APIs
Education
North Carolina State University 1992 — 1996
Bachelor of Science (BS), Biochemistry, 3.25
North Carolina State University 1992 — 1996
Bachelor of Science (B.S.), Zoology/Animal Biology, 3.25
Nash Community College 1990 — 1992
Associate of Arts and Sciences (A.A.S.), Associate of Science and Arts, 4.0
Validant August 2013 - Present
CURE Pharmaceutical, LLC May 2012 - July 2013
Stellar Biotechnologies March 2011 - May 2012
Boston Scientific September 2008 - March 2011
Invitrogen inc January 2008 - September 2008
Amgen Inc November 2002 - October 2007
Baxter BioScience May 2001 - November 2002
YTC America January 1999 - January 2000
Biosource international, inc January 1994 - January 1998
Amgen, Inc January 1993 - January 1994
Skills
Quality System, Validation, GMP, Quality Assurance, Manufacturing, FDA, Auditing, ISO 13485, Product Development, Quality Control, Process Improvement, CAPA, 21 CFR Part 11, V&V, Change Control
Education
National University
Clinical Affairs
University of California, Santa Barbara
Bachelor's Degree, Medical Microbiology and Genetic Engineering
Validant September 2013 - Present
Sandoz June 2012 - July 2013
CIBA Vision February 2011 - June 2012
Teva Pharmaceuticals November 2005 - February 2011
Kiel Laboratories February 2004 - November 2005
Southwest Research Institute February 2003 - November 2003
Education
Auburn University
BACHELORS OF SCIENCE, Chemistry
Liberty University
MASTER'S, BUSINESS ADMINISTRATION; International Business
Validant June 2012 - Present
TARGET STORES May 2012 - June 2012
KMART, INC June 2011 - April 2012
CADISTA PHARMACEUTICALS INC December 2008 - June 2010
OSG NORWICH PHARMACEUTICALS INC September 2004 - December 2008
OSG NORWICH PHARMACEUTICALS INC August 2002 - September 2004
PROCTER AND GAMBLE PHARMACEUTICALS INC May 1998 - August 2002
PROCTER AND GAMBLE PHARMACEUTICALS INC September 1995 - May 1998
PROCTER AND GAMBLE PHARMACEUTICALS INC July 1992 - September 1995
SHARON GENERAL HOSPITAL February 1983 - April 1989
Skills
Pharmaceutical Industry, Microsoft Office, Project Management, Strategic Planning, GMP, Biotechnology, Clinical Trials, Customer Service, Microsoft Excel, Validation, Clinical Research
Education
Youngstown State University 1989 — 1991
BS, Chemistry
Duquesne University 1977 — 1982
BS, Pharmacy
Validant May 2014 - Present
St. Jude Medical November 2012 - May 2014
UTSW Medical Center November 2010 - October 2011
Parkland Health and Hospital Systems August 2006 - November 2010
Katz Media Group March 2004 - April 2005
Skills
MS Office, SmartDraw, Donovan Data Systems, PeopleSoft, Office Management, Human Resources, Management, Microsoft Excel, Time Management, Budgets, Microsoft Office, Data Entry, Payroll, SAP, Epic Systems, Customer Service, Software Documentation, PowerPoint
Education
University of North Texas 1998 — 2003
BBA, Business Administration and Management, General
Eastfield College 1996 — 2000
Associate Degree
Validant October 2012 - June 2013
Midwest Compliance Laboratories August 2010 - March 2012
Pfizer 1985 - 2010
Skills
Validation, 21 CFR Part 11, V&V, Regulatory Affairs, Biotechnology, Medical Devices, Technology Transfer, Computer System..., ISO 13485, Clinical Trials, Lifesciences, Microbiology, Quality Auditing, Quality Control, Regulatory Requirements, Aseptic Processing
Education
Indiana Wesleyan University 1992 — 1994
MBA
Indiana State University 1987 — 1989
Master of Science (MS), Microbiology, General
Saint Mary of Nazareth Hospital Center 1980 — 1981
MT(ASCP)
Saint Mary of-the Woods College 1976 — 1980
Bachelor of Science (BS), Medical Technology