Project Manager Quality Assurance
Resume:
GWENDIA OSWALD
Norwich, CT *****
*******.******@******.***
***********@*****.***
EDUCATION
Bachelor of Science Zoology, Michigan State University, East Lansing, Michigan 1979
General Studies, Eastern Michigan University, Ypsilanti, MI 1980
CAREER SUMMARY
Thirty years of experience in a regulated GLP research environment. Responsibilities include regulatory consulting to client groups, contract laboratory audit support, identifying compliance process improvements, application of risk based auditing, and conduct of GLP training. Also experienced in monitoring of specialized toxicology studies, staff supervising, GLP/colleague training, computer validation, CRO evaluations/facility audits, and project managing. Familiar with MHRA/OECD regulations and guidelines.
CAREER HISTORY
PFIZER INC, Groton, CT
Planned and conducted inspections / review of methods, systems and facilities within Pfizer, which impact the conduct of regulated studies. Built strong client relationships and demonstrated diplomacy and recommended process improvements for potential GLP compliance issues.
Manager, Research Quality Assurance (RQA) 2007 - Present
• Animal Health
• GCLP team member
• Team Lead Operational Meetings. Instrumental in creating ‘one’ QA voice.
• Quality Control Client process improvements. Successfully reduced audit times and created client process improvements.
• SME: Analytical Chemistry, Genetic Tox, Computer Validation, Formulations, Safety Pharmacology
• Computer Systems: Provantis, PDS, Xybion, Watson, Analyst, Sharepoint, TeamMate, Excel, Word, GDMS, Ponemah
Senior Specialist, Research Quality Assurance (RQA) 2004-2007
• Team lead of Operational Meetings
• Client and RQA process improvements
• Part of the RQA Planning Team for the 2008 Global CRC Meeting in Atlanta GA.
• PDS Formulation Module Compliance Trouble Shooter
• Client process improvements
• Client Quality Control improvements
• Initiated an initiative to standardize audits between Ann Arbor and Kalamazoo
• Team leader of the Global ‘Histopathology/Pathology Harmonized Data Review’
• Member of the Global ‘Formulation/Bulk Harmonized Data Review’.
RQA Associate, RQA (Warner-Lambert/Parke-Davis) 1999-2004
• Responsible for client GLP training
• Lead auditor and RQA colleague trainer in contract laboratory (CRO) evaluations
• Client process improvements
• Quality Control improvements
• Managed, created presentations and conduct all ‘FDA Readiness’ and Ann Arbor GLP and annual refresher training
• Member of the Pfizer Global educational Team and assisted in the development of the Global GLP refresher training to harmonize cross-site training.
• Training of new RQA colleagues
Associate Quality Assurance Scientist, RQA (Warner-Lambert/Parke-Davis) 1997-1999
• Assisted with contract laboratory facility inspections to assure GLP compliance.
Senior Associate Scientist, Pathology and Experimental Toxicology (PET) 1994-1997
• Served as Project Manager for PET studies, supervised up to five colleagues and monitored intricate and complex toxicology studies in all species. Responsible for the conduct of acute, sub chronic and special studies including the conduct of reproductive, developmental and behavioral procedures in laboratory animals according to the protocol and departmental SOPs.
• Computer validation
• Project manager
• Technical Trainer
Senior Assistant Scientist, PET (Warner-Lambert/Parke-Davis) 1988-1994
Laboratory Technician, PET (Warner-Lambert/Parke-Davis) 1981-1988
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