R&D Partners
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Environmental Monitoring Supervisor
Philadelphia Metro Area, PA US
2024-02-15
2024-08-15
Job Type: Scientific
Job Number: JN -022024-32219
Region: Philadelphia Metro Area
Job Description
Essential Functions and Responsibilities
- Oversee day to day operations in the QC Microbiology laboratory in support of environmental monitoring and batch related microbiology testing on the weekend shift.
- Perform daily cGMP quality control laboratory microbiological testing activities and environmental monitoring of the cleanroom areas at the facility as required.
- Schedule and perform routine gas sampling at the facility as required.
- 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.
Required Education, Skills, and Knowledge
- Bachelor s degree in Biology, Microbiology or related scientific field is required
- Minimum 3 years of experience in in a cGMP Quality Control microbiology role
- Prior experience in managing a team and having direct reports.
- Basic knowledge of Compendial (e.g., USP, EP, JP, ) 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, )
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