Quality Control Microbiologist II

Role: QC Microbiologist II responsible for microbiological testing and environmental monitoring in pharmaceutical manufacturing, ensuring product sterility and compliance with cGMP and pharmacopeial standards. Responsibilities include performing routine and complex microbiological assays on raw materials, in-process, finished products, and utilities; executing environmental monitoring in classified cleanrooms; supporting aseptic process simulations and manufacturing operations; documenting data per data integrity standards; investigating deviations, and supporting audits and validations. Requirements: Bachelor's in Microbiology, Biology, or related field; 2+ years of microbiology laboratory experience within pharma/biotech/medical device industries; proficiency in USP/EP/JP standards, environmental monitoring, and microbiological techniques; experience working in ISO classified cleanrooms; familiarity with LIMS, BET/LAL software, and microbial identification systems; strong communication, organizational, and problem-solving skills; ability to gown in aseptic environments and perform repetitive lab tasks. Preferred: experience supporting media fills, environmental trending, validation activities, and electronic QMS. High-Value: cGMP microbiology, environmental monitoring, aseptic processing, regulatory compliance, medical device/pharma focus, onsite work, potential support for manufacturing schedules.