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Lead day-to-day Quality Control laboratory operations focusing on Microbiology, providing mentorship and ensuring compliance with GMP standards while managing stability, testing, and documentation processes.

The job focuses on expanding teams in Protein Science, Drug Development, Manufacturing, Quality, and supporting roles in various scientific and engineering fields.

The Specialist in QC Systems will manage and improve the Quality Management System (QMS) related to QC activities, ensuring compliance with CMC/GMP standards. This role supports electronic systems for lab operations and collaborates across functions for effective quality practices.

The Manager, QC Systems will oversee the implementation and management of QC-related electronic systems, ensuring compliance with CMC/GMP regulations and enhancing data-driven laboratory operations. Responsibilities include maintaining quality management systems, managing eSystems for sample analysis and reporting, supporting system qualification, and collaborating cross-functionally to ensure quality standards are met.

Lead hands-on QC microbiology operations including bioburden, endotoxin, microbial ID, EM sampling, utilities monitoring, contamination investigations, and mentorship. Ensure GMP inspection readiness, oversee sample workflows, review microbiology documentation, and troubleshoot assays and deviations to maintain data integrity.

The QA Operations Manager ensures quality oversight in Drug Substance manufacturing operations, develops quality systems, manages quality events, and ensures regulatory compliance, partnering with cross-functional teams.