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QC Analyst II, Quality Control Microbiology

Woburn, MA 01801

Posted: 12/09/2025 Employment Type: Contract Job Category: Scientific Job Number: 4782

Job Description

Reporting to the Associate Director of QC Microbiology, the QC Analyst II role will support the gene therapy program pipeline through the execution of GMP microbiological assays including, but not limited to, endotoxin, bioburden, total organic carbon (TOC) and growth promotion. Must be able to adapt and perform in a fast-paced environment, while still delivering high-quality results.  The QC Analyst II will be required to have strong interpersonal skills and must be able to work under minimal supervision.

Responsibilities:
  • Performs routine Quality Control microbiology testing of product and water samples.  Testing includes bioburden, plate reading, endotoxin, total organic carbon, conductivity and media growth promotion.
  • Conducts review of GMP analytical data.
  • Supports routine laboratory operations (data management, equipment cleaning, laboratory cleaning, inventory control and logbook management)
  • Ensures laboratory operational readiness and assists with troubleshooting/continuous improvement as needed.
  • Revise SOPs, forms, protocols, data reports, and other controlled documents relating to QC microbiology testing and instrumentation.
  • Performs peer review of both internal and externally generated data, as needed.
  • Supports QC deviations, investigations, root cause analysis, change control, and CAPA as needed.
Requirements / Qualifications:
  • BS or MS in Microbiology or a related discipline with 2+ years industry experience. QC GMP experience is required.
  • Hands-on experience with performing microbiological analytical testing (bioburden, endotoxin, TOC, etc.) required.
  • Independently motivated and detail-oriented with good problem-solving ability.
  • Strong oral and written communication skills with clear penmanship. 
  • Proficient in the use of computerized systems.
  • Experience with Excel and Microsoft Word.
  • Ability and desire to work in a fast-paced, start-up environment.
  • Strong collaboration skills.
  • Shift: 9:30 AM – 6:00 PM, Monday – Friday. 
  • Flex hours and occasional weekend work.
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About Woburn, MA

Ready to embark on a new career adventure? Explore our job opportunities in the vibrant area around Woburn, Massachusetts! Nestled in Middlesex County, 'Woburn, the Beautiful Land' as it translates, offers job seekers a mix of urban excitement and suburban charm. With close proximity to Boston’s bustling city life and historical landmarks like the Minute Man National Historical Park, as well as delightful local cuisines including Woburn's signature roast beef sandwiches, this area promises not just a job but a lifestyle. Attend performances at The New Repertory Theatre or catch a game at the TD Garden supporting the region's beloved sports teams. Take a stroll in Horn Pond Recreation Area or immerse yourself in art at the Whistler House Museum of Art in nearby Lowell. Join us in pursuing your career in this dynamic region; your next big opportunity awaits!