Quality Laboratory Technician

Job Summary

The Quality Laboratory (Microbiology) Technician is an essential support role within the Quality Laboratory, responsible for the routine execution of microbiological preparation and environmental monitoring. Operating within a strict cGMP environment, this role focuses on the daily sampling of cleanrooms, critical utilities, and the preparation of media and samples for senior analysts. The ideal candidate will possess a strong foundation in aseptic technique, meticulous attention to detail, and a commitment to maintaining laboratory cleanliness and compliance.

Key Responsibilities

1. Routine Environmental & Utility Monitoring (EM):

• Execute daily Environmental Monitoring (viable air, non-viable particulates, and surface contact plates) within ISO 7/8 cleanrooms and general laboratory areas.

• Perform routine sampling of critical facility utilities, including USP Purified Water (PW) and clean compressed gases.

• Ensure all sampling equipment (particle counters, air samplers) is cleaned, calibrated, and ready for daily use.

• Incubate and perform initial reads of environmental monitoring plates, escalating any excursions to senior staff.

2. Laboratory Support & Sample Preparation:

• Prepare and aliquot microbiological media, buffers, and diluents for use in compendial testing.

• Execute Growth Promotion Testing (GPT) on incoming media lots to verify viability before laboratory use.

• Assist senior analysts in the preparation of samples for Bioburden, Endotoxin (BET), and Sterility testing.

• Perform routine Gram staining and basic sub-culturing of microbial isolates.

3. Quality Documentation & Compliance:

• Accurately record all raw data, sample logs, and equipment usage contemporaneously in Electronic Lab Notebooks (ELN) and the Laboratory Information Management System (LIMS) per ALCOA+ data integrity principles.

• Follow written Standard Operating Procedures (SOPs) without deviation; promptly report any procedural errors or anomalies to laboratory management.

• Maintain accurate inventory logs for biological reagents, reference cultures, and general laboratory consumables.

4. Laboratory Housekeeping & Equipment Maintenance:

• Maintain the strict cleanliness of the microbiology laboratory and Biosafety Cabinets (BSCs) using validated sanitizing agents.

• Operate and perform routine daily maintenance on laboratory autoclaves, incubators, and water baths.

• Autoclave and safely dispose of biological waste in accordance with Environmental Health & Safety (EHS) and Biosafety Level 2 (BSL-2) guidelines.

• Wash, sterilize, and stock laboratory glassware and reusable testing manifolds.

Qualifications & Requirements

Education & Experience:

• Associate’s degree or Bachelor’s degree (B.S./B.A.) in Biology, Microbiology, Life Sciences, or a related field. (High School diploma with 2+ years of relevant laboratory experience may be considered).

• 0–2 years of experience in a laboratory environment; experience in a cGMP pharmaceutical, medical device, or food testing laboratory is highly preferred.

Technical Skills & Knowledge:

• Basic understanding of aseptic technique and the ability to strictly adhere to cleanroom gowning protocols.

• Familiarity with basic laboratory equipment (pipettes, balances, autoclaves, pH meters).

• Strong organizational skills and the ability to manage multiple routine tasks efficiently.

• Basic computer literacy and willingness to learn laboratory software systems (LIMS, ELN).

Work Environment & Physical Demands

• Must be able to successfully complete and maintain aseptic gowning qualifications for entry into controlled environments.

• Ability to stand for extended periods, lift up to 25 lbs, and perform repetitive manual tasks (e.g., pipetting, wiping down equipment).

• Requires the use of Personal Protective Equipment (PPE) including lab coats, safety glasses, gloves, and cleanroom garments.

• May require occasional weekend or off-shift work to support continuous environmental monitoring or 14-day incubation reads.