Quality Specialist with a background in GMP commercial/clinical drug manufacturing, GLP environmental research and SQF food production operations for Fortune 500, 1000 and start-up companies. SPECIALTIES: • CFR 21 211 and 113• NC/CAPA and Deviation Management• Product and Raw Material Disposition• Product Changeovers• Instrument, Software and Method Validation• Auditing (Internal, External, FDA, EU, JP)• Environmental and Utility monitoring• Water Chemistry (Air, Water, Soil, Product)• Statistical Analysis (Metrics, Tracking, Trending)• Quality Systems• LIMS, Oracle, LiveLink, Sharepoint
Listed skills include Gmp, Validation, Fda, Change Control, and 11 others.