This position supports the Quality Systems within the Quality Assurance Unit by ensuring cGMP compliance for finished pharmaceuticals and Active Pharmaceutical Ingredients (API), actively partnering with Manufacturing, Quality Control, Validation, Metrology, and other cross-functional teams to resolve quality issues, drive investigations, support batch execution, and maintain inspection readiness. Provide hands-on Quality Operations support for Development Batches, API Synthesis, commercial manufacturing, and PPQ activities by coordinating documentation, participating in production readiness activities, resolving real-time quality questions, and ensuring required records are accurate and complete, including: MBR generation and/or revision.