QC Microbiology Supervisor

Nature and Scope

The QC Microbiology Supervisor works with Microbiologists, Microbiology Technicians and Microbiology Assistants in the activities associated with the Microbiological testing required in support of sterile pharmaceuticals in accordance with company Standard Operating Procedures, cGMPs and all other company policies. The incumbent will act as a company associate in ensuring the Microbiology laboratory meets schedules and forecasts in a timely, efficient manner, while maintaining neat and accurate records. The Microbiology Supervisor will oversee the day-to-day functions of the Microbiological laboratory providing training, guidance, and support as required.

Essential Duties And Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• Ensure all work is performed and documented in accordance with existing company policies, procedures, and Current Good Manufacturing Practices, health, and safety requirements.
• Under the direction of the Microbiology Manager, supervise the Microbiology support testing team functions, Microbiologists, and technicians.
• Provide technical and administrative support for all activities related to Microbiological testing and documentation.
• Coordinates/conduct projects and special studies with the Microbiology Manager to meet department/site requirements.
• Schedule employees with respect to workload to improve efficiency. Conduct laboratory testing for customer complaints and internal investigations.
• Ensure all microbiological documentation is complete, neat, accurate and completed in timely manner.
• Issue and perform investigations, deviations, or event reports, CAPAs and ensure the closure in a timely manner.
• Train, provide technical assistance and guidance to microbiologists and technicians.
• Reviews, revise and prepares SOP’s and/or Protocols as necessary, recommend changes, update, and initiate change controls.
• Ensure tracking of support testing and release the results in timely manner.
• Review environmental monitoring tracking and trending of data in timely manner and present report to Microbiology Manager.
• Perform GAP Assessment on Microbiology procedures and keep them in compliance.
• Ensure and maintain the inventory required for the Microbiology laboratory and order supplies.
• Ensure that the laboratory is clean and sanitized.
• Assist Manager with timely completion of quarterly and other periodic projects and reports.
• Perform any other tasks/duties as assigned by management.
  
  

Education Requirements And Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Bachelor’s degree in microbiology, Biology, or equivalent Life Science curriculum required.
• Minimum of 5 years of experience working in a cGMP compliant pharmaceutical Microbiology Laboratory.
• Minimum 2 years of supervisory or lead experience required.
• Experience with Water testing, Sterility suitability & testing of the finished products and Raw Materials, Bacterial Endotoxin Suitability & testing, Container Closure Testing, filter integrity testing, Microbial Limit Testing and Microbial Enumeration testing.
• Experience with Analytical Instruments such as Vitek, Balances, pH Meter, autoclave, BET, Sterility Isolators, Active Air Samplers, Particle Counters, LIMS, BSC, Incubators, etc.
• Experience with Trackwise for Deviations, CAPAs and Veeva CR process.
• Ability to lead a microbiology group towards department target goals.
• Experience with Microbiologist I, Microbiologist II, Microbiologist III and Microbiologist Lead duties and responsibilities.
• Demonstrate responsibility and accountability working within in a multi-disciplinary team environment ability to mentor subordinates.
• Organized individual with strong attention to detail.
• Excellent computer skills and proficient in Microsoft office software.
• Excellent communications skills both verbal and written.
• Needs to be adaptable and maintain the ability to be flexible in an ever changing and challenging environment.
• Sense of ownership and ability to take responsibility.
• Ability to work overtime, weekends and holidays as needed.
  
  

Physical Environment And Requirements

• Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
• Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.
• Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
• Employee must be able to occasionally lift and/or move up to 25 pounds.
  
  

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf
  
  

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