Environmental Monitoring Supervisor

Philadelphia Metro Area, PA

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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