Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the Quality team based in Raritan, New Jersey. 

Role Overview

The Lead QC Microbiology Data Reviewer is an exempt level position with responsibilities for leading a team of microbiology data reviewers supporting the 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. The lead QC Microbiology Data Reviewer will also be responsible for the completion of environmental monitoring trend reports.

Key Responsibilities

• Scheduling of daily activities for direct reports.
• Completion of routine environmental monitoring trending.
• On-time completion of microbiology trend reports.
• 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.
• Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on-the-job training 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. 
• 6 years relevant work experience, preferably within a biological and/or pharmaceutical industry is required.
• Experience with microbiology testing preferred.
• Extensive experience trending data.
• Experienced with completion of microbiological trend reports.
• Strong Microsoft Excel experience.