This role will provide Quality Assurance oversight for Quality Control activities, including review and approval of method validations, equipment qualifications, protocols, reports, procedures, and deviations. The role supports implementation of process improvements. This is on-site in Sanford, NCConduct QA reviews and approvals for validation documents, method transfer protocols, change controls, CAPAs, compendial assessments, and related recordsReview deviations, investigations (OOS/OOT/OOE), and other Quality Events/Lab Events, Electronic build of Master Batch or any electronic record when needed, and all associated to compendial changesMake real-time quality decisions per regulations, collaborate cross-functionally to resolve technical issues, and support start-up activities as assigned
