- 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.Compensation:
$100,000 - $115,000 annually
If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at or
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.
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QC Microbiology Supervisor - Philadelphia, United States - Proclinical
Description
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: