QC Microbiology Supervisor

US$100000 - US$115000 per annum + Highly Competitive Salary
  1. Contract
  2. Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP)
  3. United States
Philadelphia, USA
Posting date: 25 Mar 2024

This vacancy has now expired. Please see similar roles below...

QC Microbiology Supervisor - Contract - Onsite

Proclinical is seeking a QC Microbiology Supervisor for a leading biotechnology company. This is a contract role located in Philadelphia, PA.

Skills & Requirements:

  • Bachelor's degree in Biology, Microbiology or related scientific field is required
  • Managerial experience required
  • Minimum five (5) years of experience in in a cGMP Quality Control microbiology role; experience with cell therapy products is a plus.
  • Basic knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards
  • High proficiency in aseptic techniques when executing microbial test methods and environmental monitoring
  • Proficient in performing technical writing (e.g., test methods, SOP's, protocols, etc.)
  • Strong technical writer with experience in writing protocols, deviations, investigations, SOPs

As the QC Microbiology Supervisor will:

  • Oversee day to day operations in the QC Microbiology laboratory in support of environmental monitoring and batch related microbiology testing
  • Perform daily cGMP quality control laboratory microbiological testing activities and environmental monitoring of the cleanroom areas
  • Schedule and perform routine gas sampling
  • Perform data analysis and result reporting of microbiology assays to support product lot release with adherence to turnaround times.
  • Oversee growth promotion testing of microbiological media using both ATCC and in-house isolates.
  • Oversee environmental monitoring of the manufacturing areas, including batch related EM, is performed accurately and according to the manufacturing schedule.
  • Ensure all in-process and lot release microbiology testing is performed and reviewed accurately and timely.
  • Ensure timely review of routine environmental monitoring data, microbiology testing data, and excursions and OOS reports are completed accurately and timely.
  • Work closely with contract labs to ensure that samples are submitted and tested in a timely manner.
  • Ensure gowning qualifications and re-qualifications for personnel needing access to classified manufacturing areas is performed, tracked, and trended.
  • Draft and execute protocols in support of site contamination control programs, as needed.
  • Oversee the maintenance and built of a microbial identification database for all in-house isolates recovered from the various monitoring programs.
  • Work closely with Sterility assurance team to ensure trend analysis and trend reports for environmental monitoring data are performed timely.
  • Support site qualification/validation/commissioning activities as needed.
  • Serve as a qualified trainer, provides guidance to other analysts.
  • Initiate and investigate deviations.
  • Mentor and support career development of direct reports.
  • Support audits and inspections as needed.


$100,000 - $115,000 annually

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at (+1) 215-531-6914 or s.briggs@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.