Microbiologist - QC Testing

Job Title: QC Microbiologist II / Scientist II, Microbiology

This role supports a cGMP-compliant Quality Control Microbiology Laboratory dedicated to the manufacture and release of biological products. The QC Microbiologist II performs routine and validation microbiological testing, contributes to controlled documentation and investigations, and collaborates closely with cross‑functional teams to ensure timely and compliant sample flow, testing, and equipment disposition.

Perform microbiological testing, including bioburden and bacterial endotoxin testing, growth promotion, biological indicator testing, and work with stock cultures in a GMP Microbiology laboratory.

Perform bioburden and endotoxin testing for water, in-process, and final product samples to support GMP manufacturing activities and release testing.

Qualify microbiological testing methods such as bioburden and bacterial endotoxin to ensure they meet regulatory and internal quality requirements.

Draft and revise standard operating procedures (SOPs), test records, out-of-specification (OOS) investigations, summary reports, and supporting documentation in accordance with cGMP and quality standards.

Review, analyze, and summarize laboratory data with guidance, ensuring data integrity, accuracy, and compliance with controlled documentation practices.

Initiate and support laboratory investigations, including OOS and atypical results, and contribute to the technical interpretation of findings and reports.

Collaborate with cross‑functional teams to help maintain supply chain continuity and appropriate equipment disposition for microbiological testing activities.

Arrange and coordinate the receipt of samples in the laboratory for testing, ensuring proper labeling, handling, and documentation.

Order laboratory supplies and maintain required inventory levels according to SOPs to support uninterrupted laboratory operations.

Maintain and promote safe laboratory practices, complying with all safety procedures, guidelines, and regulatory requirements.

Utilize laboratory documentation and quality systems such as LIMS, TrackWise, and Documentum to record, track, and manage data, investigations, and controlled documents.

Bachelor’s degree in Life Sciences or Biology is required; a degree in Microbiology is preferred.

3 to 5 years of pharmaceutical microbiology industry experience.

Hands‑on experience with bioburden testing and bacterial endotoxin testing.

Proficiency in general microbiological techniques, including aseptic techniques, light microscopy, gram staining, and handling of stock cultures.

Experience performing microbiological testing in a cGMP or GMP‑compliant laboratory environment.

Ability to draft and interpret controlled documents, including SOPs, test records, OOS investigations, and summary reports.

Experience with laboratory documentation and quality systems such as LIMS, TrackWise, and Documentum.

Ability to review, analyze, and summarize microbiological data while maintaining data integrity and compliance.

Strong understanding of laboratory safety practices and the ability to maintain a safe working environment.

Microbiology‑focused degree or coursework is highly desirable.

Collaborative mindset with the ability to work effectively with cross‑functional teams to support sample flow, supply chain, and equipment disposition.

Detail‑oriented approach to following SOPs and maintaining accurate records in electronic quality systems.

The role is based in a cGMP‑compliant QC Microbiology Laboratory that supports the manufacture and release testing of biological products. Work is primarily laboratory‑based, involving routine use of microbiological methods such as bioburden and endotoxin testing, aseptic techniques, light microscopy, gram staining, and general microbiological procedures. The position follows a Monday through Friday schedule, typically from 8:00 a.m. The environment emphasizes strict adherence to safety protocols, good documentation practices, and compliance with quality systems, including LIMS, TrackWise, and Documentum. Laboratory attire appropriate for a regulated microbiology lab, including use of personal protective equipment, is required to ensure a safe and compliant working environment.

Contract to Hire position based out of Saint Louis, MO.

Medical, dental & vision

401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available

Life Insurance (Voluntary Life & AD&D for the employee and dependents)

Short and long‑term disability

Health Spending Account (HSA)

Employee Assistance Program

Application Deadline

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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