Quality Control Microbiologist II

What You’ll Do

The QC Microbiologist II performs routine and complex microbiological testing of raw materials, in-process samples, finished products, and critical utilities. This role plays a critical part in maintaining environmental control by conducting Environmental Monitoring (EM) of classified clean rooms and providing direct microbiology and EM support during aseptic process simulations (media fills) and routine commercial fill-finish manufacturing operations. The QC Microbiologist II operates with minimal supervision under cGMP regulations, adhering strictly to USP/EP/JP pharmacopeial requirements, standard operating procedures (SOPs), and data integrity standards.

• Performs routine and non-routine testing on raw materials, in-process samples, final drug products, and critical utilities, including Purified Water, Water for Injection, Compressed Air, and Nitrogen.
• Executes standard assays including Bioburden Testing using membrane filtration and direct plating, Bacterial Endotoxin Testing (BET/LAL) kinetic assays, Sterility Testing using isolator/cleanroom hood environments, Microbial Identification, and Growth Promotion Testing on media lots.
• Maintains accurate, real-time documentation in laboratory notebooks, logbooks, and LIMS in strict compliance with cGMP and Data Integrity principles (ALCOA+).
• Performs routine cleanroom monitoring across ISO 5, ISO 7, and ISO 8 classified areas, including viable active air, non-viable particulates, surface/contact plates, and personnel monitoring.
• Conducts utility sampling including critical water system loops such as Purified Water and WFI.
• Incubates and enumerates environmental samples, performs preliminary identification of isolates, and supports trending of environmental data for periodic reporting.
• Provides dedicated EM coverage during Aseptic Process Simulations (Media Fills) and commercial fill-finish manufacturing runs.
• Executes critical monitoring including active air, passive settle plates, surface sampling, and personnel gown monitoring inside Grade A / ISO 5 critical zones.
• Performs personnel qualification and re-qualification for aseptic gowning for manufacturing and laboratory staff.
• Monitors operator adherence to aseptic technique and cleanroom behaviors during operational runs; escalates and documents discrepancies immediately.
• Initiates and supports investigations for Environmental Excursions, Out-of-Specification (OOS), Out-of-Trend (OOT), and process deviations using root cause analysis tools.
• Authors and revises Standard Operating Procedures (SOPs), test methods, validation protocols, and reporting templates.
• Supports audits and inspection readiness for internal QA, FDA, EMA, and regulatory inspections, as well as facility re-qualification and validation activities.

This role is responsible for performing microbiological testing and environmental monitoring activities that directly support the quality and sterility assurance of pharmaceutical and medical device products. The position requires the ability to work independently with minimal supervision while following established procedures and regulatory requirements. Success in this role requires strong technical knowledge of QC Microbiology testing, environmental monitoring, aseptic processing, and data integrity, along with sound judgment, attention to detail, and the ability to work effectively in a highly regulated manufacturing environment.

• Bachelor’s degree (B.S.) in Microbiology, Biology, or a closely related biological science discipline.
• 2+ years of hands‑on experience in a cGMP Quality Control Microbiology laboratory within the pharmaceutical, biopharmaceutical, or medical device industry.
• Demonstrated experience working inside…