Bella Gershenovich
Quality Assurance Director at MatTek Life Sciences
- Role
- Quality Assurance Director at Mattek Life Sciences
- Location
- Framingham, MA, US
- LinkedIn followers
- 500 followers
About Bella Gershenovich
Quality Assurance / Regulatory Affairs Professional with solid and progressive background in diverse areas of scientific research in biotechnology and applicable regulations. Expert in implementing and auditing in compliance with FDA, Good Laboratory and Good Manufacturing Practice Regulations. Demonstrated skill in applicable federal and corporate regulations, standards, policies, guidelines, and Quality Systems. Adept at developing and implementing standard operating procedures. Good working knowledge of pharmaceutical/biotechnology process, and technical concepts for GLP and GMP auditing. Assisted with IND, NDA, 510 (K), PMA submissions. Technical proficiency in Geode, Excel, Livelink, Microsoft Office, MFG Pro, Trackwise, Plateau, LIMS, Catsweb, ILIMS, and Athena
Experience
Quality Assurance Director
Aug 2020 — Present
Education
Harvard University
Biotechnology
Northeastern University
Master’s Degree, Regulatory Affairs for Drugs, Biologics, and Medical Devices
University of Massachusetts Dartmouth
BS, Biology
1999 — 2001
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