Analyst, Quality Control, Microbiology
Core
Perform routine environmental monitoring, water sampling, and microbiological testing (sterility, bioburden, endotoxin) for mRNA drug substances and products in a cGMP facility.
Role type
Individual contributor Quality Control Microbiologist
Builds
GMP-compliant microbiological test results for release, stability, and validation of mRNA therapeutics
Domain
Biopharmaceutical manufacturing / Microbiology
Required skills
Sterility testing, Bioburden analysis, Endotoxin testing, Water sampling (TOC, Conductivity), GMP compliance, cGMP regulations, Laboratory equipment maintenance, Data entry (GDP), Investigation writing, SOP authoring
Preferred skills
FDA/EU/ICH guidelines knowledge, Method transfer experience, Vitek/Isolator Technology proficiency
Technologies
Vitek, Isolator Technology, TOC analyzers, Conductivity meters
Responsibilities
Perform environmental monitoring and critical utility sampling; Execute sterility, bioburden, and endotoxin tests; Support release and stability testing; Participate in method transfers and validations; Author quality system records (deviations, CAPAs, investigations); Assist with troubleshooting and training junior staff.
Seniority
Mid-level, hands-on IC