John Kim
Batch Disposition of Cell Banks, Raw Materials, Drug Substance and Drug Product
- Role
- Senior Quality Assurance Manager at Just - Evotec Biologics
- Location
- Redmond, WA, US
- LinkedIn followers
- 500 followers
About John Kim
QA professional with demonstrated experience in the biotechnology, pharmaceutical and CDMO operations. Experienced in Downstream Drug Substance/Drug Product manufacturing and Quality Assurance: Deviation/CAPA, cGMP, Batch Disposition (Cell Banks, Raw Materials, Drug Substance and Drug Product).
Experience
Senior Quality Assurance Manager
Feb 2023 — Present
Sr. Manager responsible for executing Batch Disposition of Raw Materials, Cell Banks, Drug Substance, Placebo and Drug Product - Collaborate with CMO DP Filling site to review and approve DP MBRs and supporting documentation (EM, Specs, etc) for DP Disposition - Responsible for performing Person in Plant at DP filling sites
Education
University of the Pacific
Bachelor's degree, Chemistry
1986 — 1990
Skills
- Cleaning Validation
- Gxp
- Aseptic Processing
- Capa
- Change Control
- Gmp
- Lims
- Fda
- Api
- Sop
- Quality Assurance
- Trackwise
- Biotechnology Industry
- Pharmaceutical Industry
- 21 Cfr Part 11
- Pharmaceutics
- Validation
- Computer System Validation
- Apis
- Corrective and Preventive Action (Capa)
- Standard Operating Procedure (Sop)
- U.s. Food and Drug Administration (Fda)
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