QC Analyst - Quality Operations Laboratory
Join a cutting-edge team advancing biologics and vaccines.
Step into a dynamic, expanding Quality Operations laboratory at a strategic manufacturing site producing the world's leading biologic and top vaccine. You'll contribute to analytical method transfers, validations, and commercial testing in state-of-the‑art facilities. Reporting directly to the QC Manager, you'll help drive our lab's growth; bring your expertise and innovative approach to deliver real impact.
Key benefits of the role
Collaborative team: Focus on safety, compliance, and continuous improvement.
Meaningful work: Support the release of blockbuster drug products through precise testing.
Core responsibilities
Perform advanced testing with techniques like HPLC (HIC, CE, IEX, HP-SEC), Capillary Electrophoresis, and compendial methods, fully compliant with cGMP and cGLP.
Participate in daily QC Tier 1 meetings to report progress, deviations, and ensure smooth operations.
Develop, revise, and implement procedures, training materials, and maintenance documentation for Quality systems.
Conduct peer reviews for data integrity, achieve Right First Time KPIs, and lead laboratory aspects of OOS investigations.
Prepare for and support audits/inspections, serve as auditee, and apply root cause analysis tools (FMEA, Fishbone, 5 Whys) to resolve issues.
Promote a safe, compliant culture through effective teamwork.
Qualifications we value
Bachelor's degree or higher (ideally in Analytical Chemistry, Biochemistry, or related field).
2-3 years in a pharmaceutical lab, including HPLC experience and software proficiency; essential for product release.
Strong knowledge of cGMP, GLP, and Quality Management Systems.
Desired: Expertise in Analytical Method Transfer, LIMS, Sterility Testing, Laboratory Investigations, and related areas.
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