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Job type: Contract

Discipline: Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP)

Location: United States

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.

Compensation:

$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.

INDCQA