Manufacturing Specialist (MSAT) *PC 1603

Job description

Your Role: This position will be in the Manufacturing Science and Technology team (MS&T) responsible for implementation of GMP documentation (batch records and SOPs) and managing manufacturing related quality events (change controls, deviations, CAPAs). In addition, this position will support MSAT team to manage supplier qualification of raw materials, supplier change notifications related to the manufacture of Lenti-Viral Vector (LVV) and Cell and Gene Therapy processes. Additionally, the specialist will partner closely with internal and external stakeholders establishing partnerships to ensure compliance with cGMP and Quality Management systems to deliver our services to the clients effectively. Essential Duties and Responsibilities: - Own, initiate, and manage timely completion of Manufacturing related Quality Events (QEs) such as deviations, investigations, CAPAs, and Change Controls. - Coordinate the development, writing, collaboration and review of Standard Operating Procedures (SOPs), Standard Manufacturing Procedures (SMPs), Batch Production Records (BPRs) and other GMP documentation. - Troubleshoot processing issues, investigating in detail and establishing root cause and...