QC Microbiologist II

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.
• Interact with other departments to coordinate and maintain proper sample flow, ensuring samples are received, logged, and tested within required timelines.
• 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.
• Use aseptic techniques consistently while handling samples and performing microbiological tests to prevent contamination and ensure reliable results.
• Utilize laboratory documentation and quality systems such as LIMS, Track Wise, 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, Track Wise, 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.
• Familiarity with microbial taxonomy and identification techniques.
• Experience qualifying microbiological test methods such as bioburden and bacterial endotoxin.
• Strong written communication skills for preparing clear and accurate technical reports and documentation.
• 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…