vivian cooper

senior associate, pqa

About

I'm a biopharmaceutical professional (Manufacturing Compliance/ Quality Assurance/ CMO quality oversight/ Batch Record Review & Release), who enjoys collaborating and building consensus with personnel of diverse backgrounds and experiences. I'm currently using my knowledge of Quality Systems supporting the Plant QA department at Boehringer Ingelheim in Fremont, CA (BIFI). Throughout my career, I've held multiple positions within QA organizations (Specialist to Technical Manager level) and received many internal awards (e.g productivity, product launches, quality improvements, successful FDA inspections at CMO locations, and for completion of key Quality Investigations). When away from work, I attend classes at UCSC extension, pursuing a certificate in Regulatory Affairs. I also volunteer in my community.

Country

united states

City

san francisco

Industry

pharmaceuticals

Skill

quality assurance, batch records, batch release, investigation, corrective and preventive action, dispositions, annual product review, deviations, gmp

Experience

student

ucsc extension silicon valley

2017-4 - Present · 9 yrs 6 mos

community volunteer

various non profit organizations

2002-1 - Present · 24 yrs 9 mos

technical manager, qa lot release and assessment; investigator ii, qa assessment

genentech

1999-4 - 2001-5 · 2 yrs 2 mos

Led multi-disciplined assessment teams to investigate and resolve potential quality impacting events, primarily those events associated with Manufacturing Filling Areas. Assessed impact of deviations from cGMP, Genentech quality standard, and technical perspectives; Determined root cause/ error chain. Summarized past deviations and tracked corresponding corrective actions (CAPA) to prevent recurrence.

investigation associate, qa assessment

genentech

1998-1 - 1999-4 · 1 yr 4 mos

Supported QA Assessment Investigators and Technical Managers while conducting minor investigations. Summarized and tracked past deviations along with corresponding corrective actions (CAPA) to prevent recurrence.

specialist, qa contract manufacturing

genentech

1993-9 - 1997-12 · 4 yrs 4 mos

Provided Genentech QA oversight at Contract Manufacturing plants (CMOs) to ensure conformance with Genentech Quality Standards. Ensured operations compliance with cGMPs, Federal Regulations and Regulatory Applications. Wrote and presented Annual Product Reviews to Genentech and CMO staff. Expedited batch record review and resolution of process deviations at CMO sites.

associate, qa contract manufacturing

genentech

1992-12 - 1993-9 · 10 mos

Supported off-site Genentech QA Contract Manufacturing personnel by expediting timely disposition of bulk drug product for shipment to and filling at CMOs. Resolved majority of process deviations for QA Contract during this time period. As a back-up to QA Contract personnel, represented Genentech during filling campaigns at CMOs including monitoring manufacturing operations, batch record review and resolving lot release issues. Maintained CMOs formulae and SOPs.

senior specialist, qa clinical release; senior specialist, qa batch review; specialist, qa batch review

genentech

1986-11 - 1992-12 · 6 yrs 2 mos

Reviewed manufacturing batch record documentation for clinical and marketed products, ensuring compliance to quality standards. Facilitated observation write-ups and assisted in resolving deviations with manufacturing and technical personnel. Performed line clearances of Filling and Labeling/Packaging areas. Performed final batch history review and disposition/release of bulk and final drug products. Trained junior personnel. Maintained electronic document tracking system. Special Assignments: Recurring Issues Coordinator, New Employee Training program, Batch Yield project.