QC Microbiology Supervisor - Permanent - Philadelphia, PA
探花合集 is working alongside a biotechnology company who are seeking a QC Microbiology Supervisor to support environmental monitoring and microbiology testing programs.
Primary Responsibilities:
This role involves overseeing routine operations and performing various microbiological tests to support product release. You will also assist in site and method qualification, validation, and commissioning activities, working closely with contract labs and vendors to manage outsourced testing.
Skills & Requirements:
- Bachelor's degree in Biology, Microbiology, or a related scientific field.
- Minimum of 5 years' experience in a cGMP Quality Control microbiology role.
- Prior experience managing a team.
- Basic knowledge of Compendial requirements and standards.
- High proficiency in aseptic techniques.
- Strong technical writing skills.
- Ability to manage multiple priorities with aggressive timelines.
- High level of ownership and accountability.
- Experience with cell therapy products is a plus.
The QC Microbiology Supervisor's responsibilities will be:
- Oversee day-to-day operations in the QC Microbiology laboratory.
- Perform daily cGMP quality control laboratory microbiological testing and environmental monitoring.
- Schedule and perform routine gas sampling.
- Analyze data and report results of microbiology assays to support product lot release.
- Oversee growth promotion testing of microbiological media.
- Ensure accurate and timely in-process and lot release microbiology testing.
- Review routine environmental monitoring data and microbiology testing data.
- Work with contract labs to ensure timely sample submission and testing.
- Ensure gowning qualifications and re-qualifications for personnel.
- Draft and execute protocols for site contamination control programs.
- Maintain and build a microbial identification database.
- Collaborate with the Sterility assurance team for trend analysis and reports.
- Support site qualification, validation, and commissioning activities.
- Serve as a qualified trainer and provide guidance to other analysts.
- Initiate and investigate deviations.
- Mentor and support career development of direct reports.
- Support audits and inspections.
- Adhere to core values, policies, procedures, and business ethics.
- Comply with Safety SOPs, SDS sheets, and laboratory procedures.
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at m.raletz@proclinical.com
探花合集 is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
探花合集 Staffing is an equal opportunity employer.
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