Randy Elderkin
Senior Director of Engineering and Validation @Kincell Bio
Durham, NC, US
EMAILS
MOBILE NUMBERS
+91 *********19
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WORK HISTORY
Jul 2023 — Present
Senior Director of Engineering and Validation @Kincell Bio
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EDUCATION
2002 — 2006
State University of New York at Cobleskill
Bachelors, Computer Science/Management
2000 — 2003
State University of New York at Cobleskill
Associate of Applied Sciences, Computer Science
SKILLS
Technology TransferChange ControlRegulatory SubmissionsQuality ManagementStandard Operating Procedure (Sop)Quality ControlSix SigmaPharmaceutical IndustryFdaCleaning ValidationCalibrationValidationManufacturingSopCapaAnalytical ChemistryGmpRegulatory RequirementsComputer System ValidationQuality AssuranceRegulatory AffairsLimsQuality AuditingEquipment QualificationSoftware DocumentationLean ManufacturingGlpGampHplcCorrective and Preventive Action (Capa)TrackwiseGxpU.s. Food and Drug Administration (Fda)Pharmaceutics21 Cfr Part 11Quality System
ABOUT RANDY ELDERKIN
Pharmaceutical Management Professional with over 25 years experience in the regulated…
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