Quality Control Microbiologist III

Job Code:

Q1040

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JOB DESCRIPTION

The Microbiologist III will assist QC management on creating the Quality Documents needed to start the QC lab and Environmental Monitoring department. Once we start running, the Microbiologist 3 will perform environmental monitoring and QC testing within the QCM group.

RESPONSIBILITIES

  • Perform routine inventory.

  • Ensure lab is maintained (organized, clean, & properly supplied).

  • Observe and report any safety issues.

  • Perform routine assays for endotoxin, sterility, mycoplasma (qPCR), particulate matter, and bioburden on various finished products and raw materials.

  • Perform environmental monitoring plate enumeration.

  • Perform identification of organisms.

  • Maintain laboratory culture collection and environmental isolates.

  • Perform testing in conjunction with laboratory investigations and deviations.

  • Perform environmental and utility monitoring in clean rooms.

  • Participate in various special projects according to the needs of the department.

  • Participate in the drafting of procedures and / or operating manual, as needed.

  • Participate in the qualification and calibration of laboratory instruments.

  • Perform investigation of microbiological data deviations and OOS/OOT.

  • Perform investigations to determine root cause of environmental excursions and other non-conforming results and implement appropriate corrective and preventative actions in a timely manner.

  • Perform testing in support of facility validation activities.

  • Contribute to the preparation and review of environmental summaries and trend reports.

  • Collaborate with cross-functional teams to resolve complex method development challenges.

  • Responsible for participation in internal audits, client audits and agency inspections of the site. 

  • Perform gowning qualifications and re-qualifications for personnel needing access to classified manufacturing areas.

  • Ability to communicate and work in a fast-paced team environment.

  • Support internal and external cGMP manufacture and supply of high-quality cell and gene therapy products including, testing, QC release and stability data analyses and method data trending, deviations, out of specification investigations, and Certificates of Analysis creation.

  • Participate in method qualification and validation, transfer, and testing.

  • Maintain current knowledge base of regulations, corporate policies, and industry best practices, trends, and standards to ensure Quality Control functions remain in compliance with applicable company requirements and global regulations.

  • All other duties as assigned.

QUALIFICATIONS

  • BS/BA or greater in sciences, preferably in microbiology, biology, biotechnology, pharmaceutical sciences, or related technical field.

  • 3+ years related GMP experience in biotechnology, microbiology, environmental monitoring, pharmaceutical, manufacturing, or laboratory environment.