Quality Assurance Specialist
Resume:
EDUCATION:
Carleton University, Ottawa, Ontario
B.A. Environmental Studies May 1995
Carleton University, Ottawa, Ontario
Honors B.A. Geography, May 1993
EXPERIENCE:
Stay at home Mother
Volunteered at children’s school on a weekly basis
Wyeth Biopharma Andover, MA
QA Specialist II 1/2001-5/2002
Reviewed and released batch records, as per federal regulations and compliance
Identified issues related to manufacturing or testing that may have affected the quality (i.e. safety, purity, or efficacy of drug substance and product)
Attended in-house inspection visits by FDA, Russia and Japan for medical device filing , as a QA Raw Materials point person
Assisted in development and compilation of Device Design History File for regulatory approval and product launch (rhBMP-2 with Absorbable Collagen Sponge) (Compliant with FDA, Europe and Japan regulatory filings)
Performed critical supplier audits and acted as liaison between supplier and Quality Unit, for raw materials in medical device manufacture and supply
Participated/lead internal and external audit programs, in a cross functional environment. Actively involved in investigations and resolutions.
Quality Assurance designate for Medical Device Product Launch Team
Investigated, tracked and resolved raw material CAPAs (formerly known as NMRs)
Active member of CAPA review team (Manufacturing, Quality Control, Clinical and Commercial drug and medical device)
Reported on status and resolution of CAPAs for the Quality Unit
Was QA point person at risk analysis meetings, design control and raw material teams
QA Specialist I 9/1999-12/2000
Compiled and reviewed batch records for commercial and clinical release, as per federal regulations
Reviewed text for label proofs, production configurations and SOPs
Maintained databases for weekly report generation and distribution
Tracked NMRs (Non-Conforming Material Reports), performed follow-up investigations and resolutions
Attended weekly NMR board meetings (raw materials)
Tracked and distributed label samples
QA Coordinator 9/1997 - 8/1999
Reviewed text for label proofs, production configurations and SOPs
Tracked and distributed label samples
Maintained databases for weekly team meetings
Tracked Raw Material Non-Conformances
T.R Wilbury Laboratories Marblehead, MA
(Aquatic Toxicology, Contract Test Laboratory)
Quality Assurance Auditor 7/1996-8/1997
Performed daily audits of GLP Studies, analytical chemistry/SOP auditing, SOP maintenance and generation
Performed critical phase inspections, data audits and protocol review
Attended facility inspections by EPA
Administrator 6/1995-6/1996
Compiled and produced technical reports
General administrative duties
TRAINING:
IAPS - Preparation, packaging and labeling of clinical supplies
MARSQA - GLP interactive workshop
Pharmanet - cGMP Batch record review and investigations
COMPUTER SKILLS:
Word, Excel, Access
REFERENCES AVAILABLE UPON REQUEST
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