Vivian Cooper Email and Phone Number
Vivian Cooper work email
- Valid
Vivian Cooper personal email
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 GMPs and Quality Systems in 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.
-
Master Associate, Qa OperationsBoehringer Ingelheim Oct 2022 - PresentIngelheim Am Rhein, Rhineland-Palatinate, De
-
Senior Associate, PqaBoehringer Ingelheim Jan 2019 - Oct 2022Ingelheim Am Rhein, Rhineland-Palatinate, De(Transitioned to FTE role @ BIFI)
-
Plant Quality Assurance/ Batch Record Reviewer (Contractor)Boehringer Ingelheim Dec 2017 - Jan 2019Ingelheim Am Rhein, Rhineland-Palatinate, DeIdentifies potential product impacting events found during batch record review and organizes resolution of said issues. Provides feedback to Manufacturing to ensure timely completion of batch record review. Includes review of products under development.
-
Manufacturing Compliance Associate / Batch Record Reviewer (Contractor)Boehringer Ingelheim Oct 2017 - Dec 2017Ingelheim Am Rhein, Rhineland-Palatinate, DePerformed timely batch record review of Biotech Manufacturing Documentation (Electronic and Paper systems) for Purification Area ("Downstream"). Computer programs and systems used: BioMES, LIMS, Microsoft Word & Excel.
-
Community VolunteerVarious Non Profit Organizations 2002 - May 2020Supported education in my community, including inclusion efforts in Special Education, and school music programs. Also, designed, constructed, and contributed handmade quilts to organizations providing comfort to individuals experiencing life changing events. See volunteer section for more detail. -
Student (Regulatory Affairs Certificate Program)Ucsc Extension Silicon Valley Apr 2017 - Apr 2019Santa Clara, California, UsContinuing Education. Courses completed: Drug Development Process Good Manufacturing PracticesDrug Quality Fundamentals: Quality Control of Small Molecule Drugs and BiologicsRisk Management for Regulated IndustriesInteracting with the FDA -
Technical Manager, Qa Lot Release & Assessment; Investigator Ii, Qa AssessmentGenentech Apr 1999 - May 2001South San Francisco, California, UsLed 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 AssessmentGenentech Jan 1998 - Apr 1999South San Francisco, California, UsSupported 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 ManufacturingGenentech Sep 1993 - Dec 1997South San Francisco, California, UsProvided 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 ManufacturingGenentech Dec 1992 - Sep 1993South San Francisco, California, UsSupported 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; Sr. Specialist, Qa Batch Review; Specialist, Qa Batch ReviewGenentech Nov 1986 - Dec 1992South San Francisco, California, UsReviewed 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.
Vivian Cooper Skills
Vivian Cooper Education Details
-
California Polytechnic State University-San Luis ObispoMicrobiology -
University Of California, Santa Cruz ExtensionRegulatory Affairs
Frequently Asked Questions about Vivian Cooper
What company does Vivian Cooper work for?
Vivian Cooper works for Boehringer Ingelheim
What is Vivian Cooper's role at the current company?
Vivian Cooper's current role is Biopharmaceutical QA professional at Boehringer Ingelheim.
What is Vivian Cooper's email address?
Vivian Cooper's email address is vi****@****eim.com
What schools did Vivian Cooper attend?
Vivian Cooper attended California Polytechnic State University-San Luis Obispo, University Of California, Santa Cruz Extension.
What skills is Vivian Cooper known for?
Vivian Cooper has skills like Quality Assurance, Batch Records, Batch Release, Investigation, Corrective And Preventive Action, Dispositions, Annual Product Review, Deviations, Gmp.
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial