This role supports the QC Microbiology team by performing bioburden, microbial enumeration, endotoxin, sterility testing, and related assays. The analyst also assists with OOS investigations and maintains microbiology department-controlled areas.

Key Responsibilities:

• Perform assays such as USP 61, USP 71, USP 63, USP 85, and validated alternatives.
• Conduct growth promotion testing for media lot release, APS, and AMT.
• Execute endotoxin testing using the WinKQCL-1000 platform.
• Perform rapid sterility testing with the BacT/Alert platform.
• Support microbiological testing for media, raw materials, process intermediates, and final drug product lot release.
• Maintain laboratory inventory, equipment, and controlled areas.
• Assist with lab investigations, system suitability failures, OOS deviations, and CAPAs.
• Revise procedures, draft qualification reports, and participate in change controls.
• Ensure compliance with training requirements and GMP standards.
• Record results, maintain accurate data, and support process improvement initiatives.

Key Requirements:

• Education: Associate’s degree in Life Sciences required; Bachelor’s degree in Microbiology preferred.
• Experience:
• Knowledge of QC Microbiology and cGMP environments.
• Familiarity with bioburden, growth promotion, endotoxin, sterility testing, and aseptic methods.
• Experience with WinKQCL, LIMS, SAP, and TrackWise is a plus.
• Skills:
• Proficient in Microsoft Word and Excel with strong communication skills.
• Ability to conduct root cause analysis and suggest workflow improvements.
• Dependable team player with attention to detail and strong organizational skills.