Dave McBride

Senior Specialist Quality Assurance @FUJIFILM Biotechnologies

Ventura County, CA, US

EMAILS

[email protected]

MOBILE NUMBERS

+91 *********19

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WORK HISTORY

Oct 2022 — Present

Senior Specialist Quality Assurance @FUJIFILM Biotechnologies

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Thousand Oaks, CA, US

EDUCATION

2010 — 2013

Northeastern University

Master's degree, Regulatory Affairs

N/A

California State University Channel Islands

Bachelor's degree, Biology

SKILLS

LaboratoryBiopharmaceuticalsGlpManufacturingHplcAnalytical ChemistryGas Chromatography21 Cfr Part 11Change ControlRaw MaterialsQcPharmaceutical IndustrySopFdaRegulatory AffairsPurificationUv-VisUv/VisCapaTechnical WritingCgmpLimsAseptic ProcessingChemistryIrPharmaceuticalsHigh-Performance Liquid Chromatography (Hplc)Quality ControlGmpU.s. Title 21 Cfr Part 11 RegulationProblem SolvingBiotechnologyChromatographyTechnology TransferTrackwiseLaboratory Information Management System (Lims)Quality SystemU.s. Food and Drug Administration (Fda)ValidationStandard Operating Procedure (Sop)

ABOUT DAVE MCBRIDE

Highly motivated Quality professional striving for growth, with extensive experience in operations and manufacturing of various pharmaceutical and IVD Device products from development through production in accordance with cGMP, ICH and FDA regulations. Successful track record of optimization, validation, and technology transfer of operational methods and manufacturing processes. I have a strong team-oriented work style with excellent communication, interpersonal, analytical and problem solving skills.

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