AST & QC Specialist
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Join our mission to advance biologics and vaccine development As an AnalyticalScience & QC Specialist with a focus on Cell Biology and/or In-Process Control(IPC), you'll play a critical role in ensuring product quality, compliance, and innovation during Drug Substance (DS) and Drug Product (DP) manufacturing. This position supports day-to-day laboratory operations, analytical method transfers, datatrending, and quality investigations in a dynamic, collaborative environment aligned with GMP standards and Hilleman-laboratories Quality Policies.
- Support biologics and vaccine development through analytical science and quality control.
- Ensure product quality and compliance in a dynamic, collaborative environment.
- Focus on generating critical data and advancing vaccine development.
Responsibilities:
General
- Maintain high standards of lab operations including housekeeping, equipment maintenance, inventory management, and autoclaving to ensure smooth workflows.
- Develop, review, and update QC and Analytical Sciences (IPC) SOPs for both GMP and non-GMP testing environments.
- Perform accurate testing, documentation, and timely reporting in compliance with cGMP and non-GMP standards to support manufacturing and product release.
- Train and mentor analysts on testing methods and SOPs; lead projects such as equipment qualification, method validation, and process improvements.
- Troubleshoot and resolve analytical equipment and testing issues promptly to maintain operational efficiency.
- Investigate quality incidents and lab deviations, lead Root Cause Analysis (RCA), and implement corrective and preventive actions (CAPA).
- Collaborate with cross-functional teams and act as a liaison for tech
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