Job Code:

Q1040

/

Post Date:

October 22, 2021

JOB DESCRIPTION

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.