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
Summary
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 APS & 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.
Key requirements:
Associate degree in field of Life Science required
Bachelor Science in Microbiology or Bacteriology field of study preferred
Working knowledge in Quality Control Microbiology and working knowledge in a cGMP environment
Must have strong communication skills, both written and oral. In addition, must have proficiency in Microsoft Word and Excel
Experience with at least one of the following a plus: Bioburden / Growth Promotion / Endotoxin testing / Microorganism Identification / Sterility Testing
Demonstrated knowledge in general laboratory skills and microbiological assays, and aseptic test methods
Prior experience with WinKQCL, LIMS, SAP, and TrackWise a plus
Able to propose ideas during problem solving, root cause analysis, and process improvement events. Provides suggestions for improvement to documentation and workflows
Provides timely, clear, and accurate updates without being prompted
Records test results and maintains raw data and accurate laboratory records
Dependable and able to work well within a team. Capable of effectively representing the department in meetings and on project teams