Quality Control Microbiologist III

Job Code:

Q1040

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Post Date:

October 22, 2021

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.