QC Specialist *PC 642

Job description

Your Role: The QC Specialist is responsible for ensuring the compliant execution, oversight, and continuous improvement of Quality Control activities supporting Cell and Gene Therapy (CGT) products under cGMP conditions. This role provides subject matter expertise in analytical testing, quality event management, and method lifecycle activities. The position requires strong technical knowledge, regulatory awareness, and the ability to lead complex investigations, cross-functional initiatives, and inspection readiness activities. Requirements: - Coordinate the initiation, investigation, and timely closure of QC related quality events including deviations, OOS/OOT investigations, CAPAs, and MOCs. - In coordination with management, ensure compliance with cGMP, ALCOA+ data integrity principles, and 21 CFR Part 11 requirements. - Review analytical data executed laboratory documentation and provide suggestions for improvement. - Perform hands-on testing as needed for training, troubleshooting, or operational support. - Author and review method validation protocols and reports in accordance with regulatory guidance. - Coordinate development, revision, and approval of SOPs, protocols, repor...