What are the responsibilities and job description for the Quality Control Microbiologist position at United Pharma Technologies Inc?
Role: QC Microbiology Scientist
Location: Indianapolis, Indiana, United States
About the Role
We are seeking a highly skilled QC Microbiology Scientist to join our Quality Control team. This role supports microbiological testing, environmental monitoring, documentation, investigations, and compliance activities across the entire manufacturing site. The ideal candidate brings strong GMP experience and a passion for maintaining high-quality standards in a regulated environment.
Key Responsibilities
- Perform routine and advanced microbiological testing including bioburden, endotoxin, microbial limits, GPT, and water testing.
- Execute and manage Environmental Monitoring (viable & non-viable) of classified cleanrooms, utilities, and controlled environments.
- Write, update, and review specifications, sampling plans, test methods, and SOPs.
- Review and verify laboratory data to ensure accuracy, completeness, and compliance prior to QA submission.
- Monitor and coordinate with contract testing laboratories to ensure timely and compliant results.
- Lead and support deviations, OOS/OOT investigations, CAPA, and change control activities.
- Ensure laboratory operations follow cGMP, FDA, EU, ISO, and USP guidelines.
- Maintain a clean, organized, and inspection-ready laboratory environment with strong adherence to 5S practices.
- Train and mentor junior team members; promote accountability and cross-functional communication.
- Identify process improvements to enhance quality, reduce risk, and increase efficiency.
Qualifications
- Bachelor’s degree in Microbiology, Biology, or related scientific field (or equivalent experience).
- 3 years of microbiology experience in a GMP pharmaceutical environment.
- Strong understanding of cGMP, data integrity, and regulatory requirements (FDA, EU, USP, ISO).
- Hands-on experience in microbiological tests, EM, and QC laboratory workflows.
- Experience with documentation, SOP writing, investigations, CAPA, and QC systems.
- Preferred: experience in equipment/instrument qualification, method validation, and statistical QC tools.
- Preferred: ability to use QC data systems such as LIMS, TrackWise, Veeva, or similar platforms.