Betsey Oliver

Qc Manager Microbiology @Amgen

North Kingstown, RI, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Mar 2021 — Present

Qc Manager Microbiology @Amgen

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Manage and develop staff within the QC Microbiology department. Support product/batch release to meet patient supply by overseeing the bioburden, endotoxin, and sterility testing programs. Improve cleanroom compliance through the management of the environmental/clean utility monitoring/trending program. Support validation and qualification activities for new cleanroom areas, processes, and equipment utilized for GMP activities. Support deviation investigations and risk assessments.

SKILLS

BiopharmaceuticalsLaboratory Information Management System (Lims)Cgmp PracticesFdaUspCorrective and Preventive Action (Capa)ValidationGood Laboratory Practice (Glp)GxpCapaDeviationsEndotoxinQuality ControlToc/Conductivity/Bioburden MethodsCgmp ManufacturingDeviations/Capa/InvestigationsQuality AssuranceTraining DeliveryQuality SystemGlpAssay DevelopmentDeviation ManagementLaboratoryPharmaceutical IndustryAnnual Product ReportsLaboratory SkillsMicrobiologyVerification and Validation (V&V)21 Cfr Part 11TrackwiseComputer System ValidationWater Sampling/SystemsCleaning ValidationChange ControlEnvironmental MonitoringBiotechnologyGmpAseptic TechniqueAseptic ProcessingU.s. Food and Drug Administration (Fda)

ABOUT BETSEY OLIVER

I am a dedicated leader whose intent is to inspire and motivate others to surpass…

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Betsey Oliver — Qc Manager Microbiology at Amgen in North Kingstown, RI, US | Unifers