Manager, Quality Control Microbiology

Oakwood LabsSolon, OH
9d

About The Position

We are adding to our Pharmaceutical Quality Control Microbiology staff. We are currently seeking a management level individual to: Provide oversight of all aspects associated with the Quality Control Microbiology department. The position is responsible for management of the Quality Control Microbiology laboratory and personnel. Manage environmental monitoring of the classified manufacturing areas. Manage microbiological testing of raw materials, in-process product, finished product, and utility systems. Manage validation of microbiology test methods. Manage trending of microbiological data. Provide technical support for technology transfer of new products introduced into the GMP manufacturing facility. Provide technical support with deviations, out-of-specification, and out-of-trend investigations.

Requirements

  • Bachelor's degree in Microbiology, Biochemistry, Biology, or related field
  • Ten years' experience in an FDA regulated or ISO regulated industry.
  • Experience in a pharmaceutical GMP manufacturing setting managing a microbiology laboratory.
  • Experience managing laboratory personnel.
  • Experience with various laboratory software systems and equipment.
  • Ability to use Microsoft Suite of tools.

Responsibilities

  • Provide oversight of all aspects associated with the Quality Control Microbiology department.
  • Management of the Quality Control Microbiology laboratory and personnel.
  • Manage environmental monitoring of the classified manufacturing areas.
  • Manage microbiological testing of raw materials, in-process product, finished product, and utility systems.
  • Manage validation of microbiology test methods.
  • Manage trending of microbiological data.
  • Provide technical support for technology transfer of new products introduced into the GMP manufacturing facility.
  • Provide technical support with deviations, out-of-specification, and out-of-trend investigations.
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