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Quality Control Microbiology Analyst

Regeneron

Regeneron seeks a Quality Control Microbiology Analyst to perform microbiological testing and environmental monitoring for biopharmaceutical manufacturing. The role involves routine assays, product testing, personnel qualifications, and technical documentation in compliance with cGMP and FDA regulations.

Responsibilities Conduct environmental monitoring of controlled manufacturing areas, personnel, and utilities Perform microbiological testing including bioburden, endotoxin, plate enumeration, and growth promotion assays Execute gowning and aseptic qualification procedures for personnel Peer review data and contribute to technical writing of SOPs, protocols, and investigation reports Train employees and identify process improvement opportunities Requirements Bachelor's degree in Microbiology, Biology, or related field Minimum 12–18 months of related microbiology experience Prior GMP experience in drug substance or drug product manufacturing preferred Proficiency with Microsoft Office applications, LIMS, and laboratory management systems Ability to work Sunday–Wednesday, 2nd shift (1:00 pm–11:30 pm) Capability to perform physical tasks in cleanroom environment for up to 10 hours Compensation:

$24.76–$38.70 per hour
Vacancy posted more than 2 months ago

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