At Smith & Nephew, I manage change controls, nonconformances, and finished product specifications for two CMOs. I also evaluate complaints and manage and write APRs for two pharmaceutical products.
I review and release third-party CMO documentation for product lots, and create Certificates of Analysis and approve laboratory documentation for product release and testing. I also participate in internal and external audits and inspections.
At Monarch PCM, I successfully implemented a serialization system and submitted an FDA Drug Listing to CDER. I investigated deviations, nonconformances, out-of-specification results, and CAPAs, and assisted with the facility’s initial FDA audit.
Earlier, I built up the microbiology lab for a start-up OTC pharmaceutical company, writing and implementing lab procedures and protocols and facilitating validation of two autoclave systems. My background also includes medical device testing and R&D microbiology at C.G. LABORATORIES, INC. and A Novartis Company, Alcon Laboratories, Inc.
