Primary Quality Assurance Representative for review of GLP Final Reports, GMP Certificates of Analysis (CoA’s), Assay Validations, deviations, and CAPAs. Reviews laboratory testing data or manufacturing batch records in accordance with current Good Manufacturing Practices (cGMP), and Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies, as applicable. Monitor processes for adherence to established procedures/regulatory compliance. Provides guidance for quality related issues and consults with QA Management to resolve complex quality issues in a timely manner.
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