QC Analyst II
Job Responsibilities:
- Perform USP 61, USP 71, USP 63, and USP 85 assays, as well as validated alternatives.
- Conduct growth promotion testing on liquid and agar media for lot release and APS & AMT growth promotions.
- Execute BET (endotoxin) testing using the WinKQCL-1000 platform.
- Perform and monitor rapid sterility testing using the BacT/Alert platform.
- Conduct microbiological assays for media, raw materials, process intermediates, and final drug product lot release.
- Assist in maintaining the laboratory, including inventory management, consumable stock, and equipment upkeep.
- Support investigations into system suitability failures, OOS excursions, and deviations.
- Participate in change control actions, revise procedures, and draft qualification reports.
- Ensure compliance with all required training and follow safety procedures.
- Perform additional duties as assigned.
Skills:
- Strong attention to detail, organization, and time management skills.
- Working knowledge of USP 71, BacT/Alert platform, and endotoxin testing.
- Familiarity with bioburden, growth promotion, sterility testing, and microbiological assays.
- Proficient in Microsoft Word and Excel.
- Experience with WinKQCL, LIMS, SAP, and TrackWise is a plus.
- Excellent communication skills, both written and verbal.
- Ability to contribute to problem-solving, root cause analysis, and process improvement.
- Dependable team player who can effectively represent the department in meetings.
Education/Experience:
- Associate degree in Life Science required.
- Bachelor’s degree in Microbiology or Bacteriology preferred.
- Working knowledge in Quality Control Microbiology and experience in a cGMP environment.
- Prior experience with microbiological assays and aseptic test methods is a plus.
- Ability to record accurate test results and maintain raw data and laboratory records.
- Strong analytical and problem-solving abilities
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