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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