Quality Control Microbiologist II

Job Code:

Q1044

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JOB DESCRIPTION

The Microbiologist II 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 II will perform environmental monitoring and QC testing within the QC Microbiology 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.

  • Assist in the investigation of microbiological data deviations and OOS/OOT.

  • Assist in the investigation 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.

  • 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.

  • 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.

  • 2-3 years related GMP experience in biotechnology, microbiology, environmental monitoring, pharmaceutical, manufacturing, or laboratory environment.