Mike Metrock
Living, loving 😊
- Role
- Senior Quality Specialist at BioCryst Pharmaceuticals, Inc.
- Location
- Baltimore, MD, US
- LinkedIn followers
- 500 followers
About Mike Metrock
Over 20 years of experience in bio pharmaceutical manufacturing and quality assurance. Highly skilled in implementation and execution of both manual and electronic QMS for the management of SOPs, Batch Records, CAPA, Deviation, and Change Control. Experience spanning small, start up CMOs through large commercial pharmaceutical companies.
Experience
Senior Quality Specialist
BioCryst Pharmaceuticals, Inc.
Sep 2024 — Present
Education
East Stroudsburg University of Pennsylvania
BS
1995 — 1999
Skills
- Software Documentation
- Cell Culture
- Purification
- Pharmaceutical Industry
- Sop
- Fda
- Sap R/3
- Gmp
- Biopharmaceuticals
- 21 Cfr Part 11
- Glp
- Computer System Validation
- Verification and Validation (V&V)
- Biotechnology
- Validation
- Aseptic Technique
- Gxp
- Aseptic Processing
- Trackwise
- Upstream
- Standard Operating Procedure (Sop)
- Documentation
- Downstream Processing
- Bacterial Culture
- Good Laboratory Practice (Glp)
- Capa
- Cip
- U.s. Food and Drug Administration (Fda)
- Sop Development
- Lims
- Change Control
- Technology Transfer
- Quality System
- V&V
- Cgmp
- Fermentation
- Vaccines
- Technical Writing
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