Sr Associate Quality Control I

Let’s do this. Let’s change the world. In this vital role you will support ANC QC Sample Management and Stability operations, including site start-up and ongoing program delivery. The role establishes and executes sample-handling and stability processes, coordinates requests and protocol-timed activities, protects sample integrity, and supports laboratory equipment and computerized-system readiness. The role prepares accurately controlled documentation and supports qualified testing, validation, and method or knowledge transfers. It manages routine work with minimal supervision, resolves issues within training and authorization, and promptly escalates complex quality or timeline risks.

·       Receive, identify, track, store, transfer, retain, and dispose of QC samples under approved procedures; maintain chain-of-custody and records in LIMS and other approved systems.

·       Coordinate stability requests with Global Stability Coordinators and Product Quality Leads; manage assigned clinical and commercial drug substance and intermediate materials and complete pulls, processing, study starts, and placement within approved protocol timelines.

·       Protect stability-sample integrity through required storage conditions, study segregation, and backup controlled-temperature chamber readiness.

·       Support lab start-up and readiness by establishing workflows and preventive maintenance, supporting equipment and system installation, qualification, and validation, coordinating vendors and IOQ, and assisting with procurement and method or knowledge transfers.

·       Perform assigned sample-management procedures and routine QC testing after qualification; operate equipment, review data, resolve routine issues, and escalate complex or quality-impacting concerns.

·       Prepare and review SOPs, methods, safety assessments, trend and technical reports, and qualification or validation summaries; follow cGMP, good documentation practices, and safety requirements.

·       Support audits, investigations, and change control; coordinate priorities and status with QC, Manufacturing, and stability partners; contribute to improvements and mentor or orient team members.