John Kim

Senior Quality Assurance Manager @Just - Evotec Biologics

Redmond, WA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Feb 2023 — Present

Senior Quality Assurance Manager @Just - Evotec Biologics

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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

1986 — 1990

University of the Pacific

Bachelor's degree, Chemistry

SKILLS

Cleaning ValidationGxpAseptic ProcessingCapaChange ControlGmpLimsFdaApiSopQuality AssuranceTrackwiseBiotechnology IndustryPharmaceutical Industry21 Cfr Part 11PharmaceuticsValidationComputer System ValidationApisCorrective and Preventive Action (Capa)Standard Operating Procedure (Sop)U.s. Food and Drug Administration (Fda)

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).

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