This is a direct-hire (permanent) position at our client, and will be fully on-site in Philadelphia, PA.There are two available Night Shifts:Sunday to Wednesday:- Week 1: Sunday to Wednesday from 6:00pm - 5:30am
- Week 2: Sunday to Tuesday from 6:00pm - 6:30am
or
Wednesday to Saturday- Week 1: Wednesday to Saturday from 6:00pm - 5:30am
- Week 2: Thursday to Saturday from 6:00pm - 6:30am
OverviewThe Supervisor, Microbiology Testing & Environmental Monitoring supports the environmental monitoring and microbiology testing programs at the company's Cell Therapy Center. This is a working Supervisor role responsible for overseeing the routine operations and performing testing such as sterility testing, endotoxin testing, media growth promotion, environmental monitoring, plate reading, data review, microbiology investigations, and other microbiology methods as needed to support product release. This position also assists in site and method qualification, validation, and commissioning activities. This position works closely with contract labs and vendors to manage outsourced testing.
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, ensuring it 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 are performed, tracked, and trended.
- Draft and execute protocols in support of site contamination control programs, as needed.
- Oversee the maintenance and build of a microbial identification database for all in-house isolates recovered from the various monitoring programs.
- Work closely with the 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 and provide guidance to other analysts.
- Initiate and investigate deviations.
- Mentor and support the career development of direct reports.
- Support audits and inspections as needed.
- Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
- Perform miscellaneous duties as assigned.
Required Education, Skills, and Knowledge- Bachelor's degree in Biology, Microbiology, or related scientific field is required.
- Minimum five (5) years of experience 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, SOPs, protocols).
- Strong technical writer with experience in writing protocols, deviations, investigations, SOPs.
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
- High level of ownership and accountability.
Preferred Education, Skills, and Knowledge- Experience with cell therapy products is a plus.
Physical Demands and Activities Required:- Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coverall, masks, gloves, etc.
- Must meet requirements for and be able to wear a half-face respirator.
- Able to stand and/or walk 90% (and sit 10%) of a 10-hr day, which may include climbing ladders or steps.
- Must be able to use near vision to view samples at close range.
- Able to crouch, bend, twist, reach, and perform activities with repetitive motion.
- Must be able to lift and carry objects weighing 45 pounds.
Work Environment:- This position will work in both an office and a manufacturing lab setting.
- When in the lab, must be able to work in a lab setting with various chemical/biochemical exposures, including latex and bleach.
- Able to work in a cleanroom with biohazards, human blood components, and chemicals.
- Potential exposure to noise and equipment hazards and strong odors.
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