Quality Control Biologics Specialist
Hybrid · Bulle, Fribourg, Switzerland
Job Summary
Biological Quality Control Specialist providing technical expertise for analytical methods and laboratory equipment, leading analytical investigations and deviations, supporting implementation of new methods/equipment, contributing to GMP compliance and regulatory inspections, and driving continuous improvement of analytical processes. Collaborates with Quality Control, Manufacturing, Supply Chain, Technical Services, Quality Assurance, HSE, and global functions; interacts with Analytical Development and Centers of Excellence on investigations, method transfers, equipment implementation, and strategic projects related to laboratory analytics.
Required Qualifications
- Master’s degree in a scientific discipline or equivalent experience in the biopharmaceutical industry
- Minimum of five years of experience in pharmaceutical or biotechnology Quality Control
- Strong expertise in analytical techniques, including ELISA, bioassays, HPLC, UPLC, and UV spectroscopy
- Good knowledge of GMP regulations, the European Pharmacopoeia, USP, and JP requirements
- Experience managing investigations, deviations, and corrective and preventive actions (CAPAs)
- Excellent organizational, leadership, and communication skills, with fluency in English
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