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
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Perform routine inventory.
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Ensure lab is maintained (organized, clean, & properly supplied).
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Observe and report any safety issues.
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Perform routine assays for endotoxin, sterility, mycoplasma (qPCR), particulate matter, and bioburden on various finished products and raw materials.
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Perform environmental monitoring plate enumeration.
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Perform identification of organisms.
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Maintain laboratory culture collection and environmental isolates.
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Perform testing in conjunction with laboratory investigations and deviations.
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Perform environmental and utility monitoring in clean rooms.
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Participate in various special projects according to the needs of the department.
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Participate in the drafting of procedures and / or operating manual, as needed.
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Participate in the qualification and calibration of laboratory instruments.
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Perform investigation of microbiological data deviations and OOS/OOT.
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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.
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Perform testing in support of facility validation activities.
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Contribute to the preparation and review of environmental summaries and trend reports.
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Collaborate with cross-functional teams to resolve complex method development challenges.
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Responsible for participation in internal audits, client audits and agency inspections of the site.
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Perform gowning qualifications and re-qualifications for personnel needing access to classified manufacturing areas.
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Ability to communicate and work in a fast-paced team environment.
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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.
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Participate in method qualification and validation, transfer, and testing.
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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.
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All other duties as assigned.
QUALIFICATIONS
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BS/BA or greater in sciences, preferably in microbiology, biology, biotechnology, pharmaceutical sciences, or related technical field.
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3+ years related GMP experience in biotechnology, microbiology, environmental monitoring, pharmaceutical, manufacturing, or laboratory environment.