Microbiology Supervisor

Position Summary: 

The Microbiology Supervisor is responsible for supervising the activities of microbiology technician(s). Ensures timely and accurate completion of required testing of Environmental Monitoring (EM)/Utilities, raw materials, in-process and finished products. Assures compliance to GMP and company specifications as well as USP. The Microbiology Supervisor identifies areas for validation and/or improvement and develops protocols for same. The Microbiology Supervisor keeps the QC Manager informed of all departmental activities and product related events.

Responsibilities:

  • Directs all aspects of Microbiology and is responsible for technical oversight of all testing performed in Microbiology.
  • Provide coaching, mentoring, and training to direct reports to increase skill and efficiency.
  • Schedules and supervises day to day work activities for direct reports. Accountable for the compliance, accuracy, and timeliness of responsibilities and work assigned, including subordinates.
  • Perform routine microbiological tests accurately and safely including (but not limited to): Growth Promotion, Suitability, Raw Material Bioburden, Material Testing, Gram Stain and Identifications, Purified Water testing, and analyzes and interpret data. Performs related activities such as data entry and purchasing of supplies.
  • Sampling and routine testing of finished and In-process material.
  • Conduct environmental monitoring of various areas in manufacturing plant.
  • Perform microbiology recoveries for cleaning verifications and validations.
  • Compile and interpret results of microbiology and environmental monitoring tests.
  • Write, review, revise and execute SOP’s, and validation and qualification protocols.
  • Design, execute, document and interpret microbiology special studies.
  • Follow cGMP and cGLP including (but not limited to) performing daily calibrations and monitoring of laboratory instruments, incubators, refrigerators, autoclave and maintaining log-books and record maintenance.
  • Perform logbook reviews and maintain archived records and documentation.
  • Complete and sustain training requirements.
  • Perform Microbiology Out of Specifications (OOS) Investigations, Root Cause Analysis and Corrective/Preventative Actions.
  • Analyze trends in data and provide solution(s) or improvement(s) for microbiology.
  • Familiar with Cosmetic and API (Active Pharmaceutical Ingredient) microbiology requirements and industry expectations.
  • Responsible for laboratory efficiency and continuous improvements.
  • Support the microbial resolve of product complaints.
  • Remains current and knowledgeable on regulatory issues as they relate to Cosmetic and Pharmaceutical Microbiology.
  • Other duties as assigned.

Qualifications:

  • Bachelor’s Degree in Microbiology, Biology or closely related field.
  • Five (5) years of experience working in a microbiology laboratory.
  • Possess excellent interpersonal skills and ability to work closely with the Quality Control Team
  • Good written and verbal communication skills, excellent documentation and organizational skills and demonstrate critical thinking skills, attention to detail and the ability to work independently and with others.
  • Perform independent work related projects, interpretation of results and complete project with Final Report.
  • Awareness of Cosmetic and Active Pharmaceutical Ingredients requirements

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