QC Microbiologist I - GMP Lab & Bioburden Testing

Actalent; Missouri; On-site; USD 39,000 - 43,000; Full time

Job summary

Actalent in Saint Louis, MO seeks a QC Microbiologist I / Scientist I to join a cGMP laboratory, supporting the manufacture and release of biological products. You will perform bioburden and endotoxin testing, draft controlled documents, and ensure data integrity and compliance with standards.

The role emphasizes aseptic technique, accurate testing, and collaboration with cross-functional teams to maintain sample flow, inventory, and equipment disposition in a regulated environment.

Qualifications

• At least 6 months of microbiology experience in a GMP-regulated environment.
• Hands-on experience with aseptic techniques in a laboratory setting.
• Proficiency in bioburden testing and bacterial endotoxin testing.
• Practical experience with general microbiological techniques, including light microscopy and gram staining.
• Familiarity with microbial taxonomy and identification.
• Ability to write, interpret, and follow controlled documents such as SOPs, test records, investigations, and reports.
• Experience working with laboratory documentation and quality systems such as LIMS, Trackwise, and Documentum.
• Strong attention to detail and commitment to data integrity and cGMP compliance.
• Ability to work effectively in a regulated QC laboratory environment supporting biological product manufacturing.

Responsibilities

• Perform bioburden and bacterial endotoxin testing for water, in-process, and product samples in a GMP microbiology laboratory.
• Conduct microbiological testing including bioburden, bacterial endotoxin testing, growth promotion, biological indicators, and stock cultures.
• Support bioburden and endotoxin validation work to ensure methods and systems meet regulatory and internal quality requirements.
• Draft and revise controlled documents such as SOPs, test records, out-of-specification (OOS) investigations, summary reports, and supporting documentation.
• Write and technically interpret controlled documents and reports, ensuring clarity, accuracy, and compliance with cGMP standards.
• Review, analyze, and summarize microbiological data with guidance, ensuring data integrity and proper documentation.
• Initiate investigations when required, including OOS and other quality-related events, and contribute to root cause analysis and corrective actions.
• Interact with cross-functional departments to ensure proper sample flow into the laboratory and timely testing of materials.
• Coordinate with other departments to maintain supply chain continuity and appropriate equipment disposition to support laboratory operations.
• Order laboratory supplies and maintain required inventory levels according to established SOPs.
• Arrange and manage the receipt of samples into the laboratory, ensuring correct labeling, handling, and documentation.
• Maintain and promote safe laboratory practices, following all safety procedures and guidelines.
• Use aseptic techniques consistently while handling samples to prevent contamination and ensure reliable test results.
• Apply general microbiological techniques such as light microscopy, gram staining, and microbial taxonomy and identification in routine work.
• Support GMP manufacturing activities and release testing through accurate, timely, and compliant microbiological analyses.

Skills

GMP environment

Aseptic techniques

Bioburden testing

Endotoxin testing

Microscopy

Gram staining

Data integrity

LIMS Trackwise Documentum

SOPs & investigations

Attention to detail

Education

Bachelor’s degree in Life Sciences or Biology

Job description

Actalent in Saint Louis, MO seeks a QC Microbiologist I / Scientist I to join a cGMP laboratory, supporting the manufacture and release of biological products. You will perform bioburden and endotoxin testing, draft controlled documents, and ensure data integrity and compliance with standards.

The role emphasizes aseptic technique, accurate testing, and collaboration with cross-functional teams to maintain sample flow, inventory, and equipment disposition in a regulated environment.