QC System Specialist

Job description

Role Description Position Summary: Owns day-to-day execution and coordination of the stability program to ensure compliant study setup, sample management, testing coordination, data review support, and on-time reporting. Partners cross-functionally to maintain high data integrity, inspection readiness, and continuous improvement. Acts as site laboratory management system (SAP/zLIMS) subject matter expert. Maintains compliance through creation and maintenance of biological product specifications and COA templates. The successful candidate must be a self-starter and have the ability to prioritize work based on the needs of Production, Quality Assurance, Quality Control, Regulatory, Global Manufacturing Technologies and Supply Chain. Stability: - Coordinate stability studies (routine stability, confirmation of expiry, USDA/regulatory commitments, as well as new product registration) in alignment with approved protocols, regulatory requirements and internal procedures. - Create/maintain stability schedules, pull plans, timepoints, and tracking logs to ensure on-time sample pulls, testing, and reporting. - Ensure accurate stability sample receipt, labeling, storage placement, chain-of-c...