Job Description

Must have: Attention to detail, Organization skills, Time management
Degree in Biology (Microbiology a plus)
Highly desirable: working knowledge of USP 71
Working knowledge of BacT/Alert

Quality Control Analyst - Microbiology
The purpose of this role is to support the Quality Control, Microbiology Safety Team conducting bioburden, microbial enumeration, endotoxin, sterility testing, and other tests as needed. The individual in this role will support assays associated with QC-Microbiology/EM, assist with OOS investigations, and general upkeep of the microbiology department-controlled areas.

Key responsibilities:
• Performance of USP 61, USP 71, USP63, USP85 assays or validated alternatives
• Performance of growth promotion testing on liquid and agar media, for lot release, as well as for Client & AMT growth promotions
• Execution of BET (endotoxin) testing using the WinKQCL-1000 platform
• Perform and monitor rapid sterility testing using the BacT/Alert platform
• Performance of microbiological assays for media, raw material, process intermediates, and final drug product lot release
• Assistance with maintenance of the laboratories, inventory of consumables, and equipment maintenance
• Support Lab Investigation, system suitability failures, OOS excursions, and deviations
• Participate in change control actions: Revise procedures and draft qualification reports
• Maintain compliance with all required training
• Perform other duties as assigned.

Additional Information

All your information will be kept confidential according to EEO guidelines.