Quality Control Microbiologist II

About the role

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 cleanrooms and providing direct microbiology and EM support during aseptic process simulations (media fills) and routine commercial fill-finish manufacturing operations.

Responsibilities

• 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.
• Maintains 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.

Requirements

• 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 classified cleanrooms (ISO 5–8) and providing direct microbiology and EM support for aseptic manufacturing or fill-finish operations.
• Proficiency with USP/EP/JP pharmacopeia, including USP , , , , and , and cGMP/FDA/EMA regulatory guidelines.
• Experience with BET/LAL kinetic software, particle counters, bioburden filtration apparatus, automated microbial identification systems, and LIMS/eQMS systems.
• Strong understanding of microbiological testing, environmental monitoring, aseptic processing, contamination control, and applicable laboratory practices.
• Strong verbal and written communication skills with the ability to accurately document technical information and communicate effectively with Quality, Manufacturing, and other cross-functional teams.
• Strong analytical, organizational, and problem-solving skills with the ability to work independently and manage multiple priorities.
• Ability to gown fully in aseptic cleanroom suit assemblies, including hoods, goggles, masks, boots, and double-gloves, and remain in classified environments for extended periods of 4+ hours.
• Ability to lift up to 25 lbs., maneuver sampling equipment, and perform repetitive laboratory tasks including pipetting, plate streaking, and membrane filtration.
• Willingness to support manufacturing schedules, which may include occasional weekend, evening shift, or holiday coverage.

Qualifications

• Experience supporting Aseptic Process Simulations (Media Fills) and commercial fill-finish manufacturing operations.
• Experience with environmental monitoring in Grade A / ISO 5 critical zones.
• Experience performing personnel gowning qualification and re-qualification.
• Experience supporting environmental monitoring trending, facility re-qualification, or validation activities.
• Experience with electronic Quality Management Systems and laboratory information management systems.

Skills

• Microbiology
• Environmental Monitoring
• Aseptic Processing
• Data Integrity

Benefits

• Comprehensive healthcare benefits
• Health savings account
• 401(k) plan with up to 5% company match which includes immediate vesting
• Employee stock purchase plan at a 15% discount
• Accrued paid time off
• Additional long-term incentives including stock awards