QC Microbiology Data Reviewer

Legend Biotech is seeking QC Microbiology Data Reviewer as part of the Quality team based in Raritan, NJ. 

Role Overview

The QC Microbiology Data Reviewer is an exempt level position with responsibilities for reviewing microbiology data and documentation generated from the Environmental Monitoring program, drug product and intermediates testing from the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP environment.

Key Responsibilities  

• Responsible for reviewing routine EM sampling, including viable/non-viable air and surface sampling, related to Raritan manufacturing processes, either for clinical trials and commercial operations in a controlled cGMP cleanroom environment.
• Create, review and approve relevant QC documents, logbooks, SOP’s and WI’s.
• Ensure microbiological control strategy is consistent with cGMP requirements.
• Participate in training and delivery of Operations aseptic technique and microbiology awareness training program.
• Maintain, re-evaluate and communicate key critical inputs to site environmental monitoring program.
• Perform peer review/approval of laboratory data including endotoxin, sterility, growth promotion, as well as other microbiological assays.
• Utilize electronic systems (LIMS) for execution, documentation, review of testing.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Other duties will be assigned, as necessary.

Requirements

• A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
• A Minimum of 5 years work experience within a biological and/or pharmaceutical industry is required.
• A Minimum of 2 years relevant work experience.
• Experience in a Quality Control setting is preferred.
• Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is preferred.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.
• Detailed knowledge of routine and non-routine testing and sampling methods, techniques and related equipment is preferred
• Detailed knowledge of the shop floor manufacturing process is preferred
• Comprehensive knowledge of trending using statistical analysis is preferred
• Ability to pay attention to details and follow the procedures is required
• Excellent written and oral communication skill are required
• Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Comfortable with speaking and interacting with inspectors.
• This position may require occasional travel to partner sites in NJ or PA as business demands.

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