Stability Specialist
Current• Overall management of Trillium’s stability program of over one hundred drug products, including annual, pre-market, and specially requested stability.• Lot request, study set-up, testing submission, result summary, trend analysis, and customer result delivery through CALS (LIMS) & JD Edwards ERP.• Creation, revision, and maintenance of stability related SOPs, stability program protocols for existing and pre-market products, and all stability-related tracking and metrics.• Serve as stability SME during audits, primary liaison for stability related issues regarding Quality Assurance and Compliance in regulation with ICH guidelines.• Billing management of stability testing hours, storage, and pre-market project related costs.• Guidance and training for new and current employees on stability responsibilities.