What are the responsibilities and job description for the Quality Control Microbiologist position at United Pharma Technologies Inc?
Role: QC Microbiology Data Reviewer
Location: Illinois, United States
Job Summary
We are seeking a detail-oriented QC Microbiology Data Reviewer to ensure the accuracy, completeness, and compliance of microbiological testing data generated in a GMP environment. This role provides critical quality oversight to verify data integrity, support investigations, and ensure lab results meet regulatory standards prior to batch release.
Key Responsibilities
- Review microbiology test data including bioburden, endotoxin, sterility, EM, water testing, growth promotion, and microbial ID.
- Ensure analysts follow approved SOPs, test methods, and protocols.
- Verify all documentation meets GMP and ALCOA data integrity requirements.
- Review raw data, calculations, instrument printouts, electronic records, and logbooks for accuracy.
- Confirm results meet acceptance criteria and escalate OOS/OOT or deviations.
- Support deviation, OOS/OOT, and investigation activities with clear data review inputs.
- Identify documentation gaps, inconsistencies, or noncompliance issues and recommend improvements.
- Review and approve lab reports, trending summaries, and certificates of analysis (COAs).
- Collaborate with QC lab personnel, QA, and supervisors to maintain high-quality data standards.
- Assist in revising SOPs, forms, and templates to enhance clarity and compliance.
Qualifications
- Bachelor’s degree in Microbiology, Biology, or related scientific discipline.
- 2 years’ experience in a microbiology lab within GMP/regulated environment.
- Prior experience in data review or QC/QA microbiology preferred.
- Strong understanding of microbiological techniques, aseptic practices, and test principles.
- Knowledge of GMP, GLP, and ALCOA data integrity standards.
- Familiarity with laboratory documentation systems and microbiology instrumentation.
- Excellent attention to detail with strong analytical and review skills.
- Strong communication, organization, and time-management abilities.
- Ability to work both independently and collaboratively in a fast-paced environment.