QC Microbiology Data Reviewer

4 weeks ago

Raritan, New Jersey, United States Legend Biotech US Full time
Job Title: QC Microbiology Data Reviewer

Legend Biotech US is seeking a highly skilled QC Microbiology Data Reviewer to join our Quality team based in Raritan, NJ.

Job Summary:

The QC Microbiology Data Reviewer will be responsible 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:
  • Review 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.

Legend Biotech US is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

Legend Biotech US maintains a drug-free workplace.

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