Microbiology Supervisor

 

summary/objective
The Microbiologist Supervisor is responsible for leading the microbiology laboratory in day-to-day activities, such as ensuring all raw materials, finished products, stability program samples, and research/validation batches are

tested within company-mandated time periods. The Microbiology Supervisor may also serve as the stand-in

approver when the Microbiology Manager is out of the office. The Microbiology Supervisor will delegate or, when necessary, complete the following task-related activities listed below:

 

essential functions

1. Adhere with SOPs and regulatory requirements such as GMPs, GDPs, GLPs and OSHA regulations
2. Direct training as the subject matter expert of all microbiologists and maintain training documents
3. Update the Associate Director of Quality Systems / Microbiology, QA and other plant management on microbiology testing and related activities
4. Ensure the following microbiological testing related to the following microbiological test methods is either completed or performed by the microbiologists:
   • Microbial Enumeration and Specified Microorganism (MET / SMT) testing per USP <61>/<62>
   • Antimicrobial Effectiveness Testing (AET) per USP <51>
   • Preservative Effectiveness Testing (PET) per USP <51>
   • Purified/Source Water testing per USP <1231>
   • Environmental Monitoring (EM)
   • Water Activity Determination per USP <1112>
   • Cleaning validation/verification microbiological recovery testing
   • Isolate identification testing using the VITEK 2 Compact Isolate Identification System
   • Microbiological growth promotion and sterility verification testing
5. Initiate, revise, or review the following Plant-controlled documents to ensure they are current and in compliance:
   • SOPs, forms, and logbooks,
   • Specifications
   • Change Controls
   • Microbiology Investigations / Deviations
6. Initiate and perform the following validation activities:
   • Critical Systems Qualification of Equipment and/or Production Controlled Rooms
   • Test Method Validation
   • Preservative Effectiveness Studies
7. Approve/review microbiology test records and logbooks
8. Maintain and coordinate equipment/instrumentation maintenance, calibration, and repair work
9. Contact media and supply vendors to troubleshoot issues
10. Schedule and approve scheduled time off by microbiologists
11. Schedule and ensure the following microbiology activities are promptly and compliantly performed by the microbiologists: (This list is not designed to cover all activities, duties or responsibilities)
    • Purified water system testing on required intervals
    • Environmental monitoring testing on required intervals
    • Isolate Identifications on Vitek ID System
    • Initiate Isolate Identification Reports when necessary
    • Updating, reviewing, and approving microbiological trending
    • Approve/review daily temperature readings
    • Controlled substance compliance
    • Media and supply inventory maintenance, including ordering and releasing media, buffers, and microorganism cultures
    • Cleaning and sanitization activities in the microbiology laboratory

 

required education and experience

• Bachelor's degree in microbiology, biology, or related scientific field or equivalent experience
• Seven (7) to ten (10) years of experience in a pharmaceutical microbiology laboratory
• Knowledge of cGMP/GLP/GDP, USP / EU regulatory requirements
• Experience performing microbiological testing / environmental monitoring using aseptic techniques
• Excellent technical writing, project management, and organizational skills
• Excellent interpersonal communication and organizational skills
• Qualified to work with controlled substances 
• Knowledge and experience performing serial dilutions
• Experience Handling Biohazardous materials
• Knowledge of USP, EU, and FDA requirements related to the position
• Experience with regulatory audits

 

position type/expected hours of work
This is a full-time position on 1st shift and days/hours of work are Monday through Friday but extended (earlier or later) work times or weekend work may be required when the production needs exist or until the daily tasks or goals are met. 

 

physical demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  The employee is required to sit at a computer for long periods of time and occasionally required to stand for long periods of time collecting or processing samples.  Specific vision abilities required by this position include close vision and color vision.

 

work environment

This job operates in a professional office environment and business casual attire with socks and closed toe shoes is required.  This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.  This role requires good hygiene and hair / facial hair must be kept well-trimmed to prevent incidental contamination during testing.  Working with Biohazardous materials is also prominent.