Quality Control Specialist

5 hours ago


Woburn, Massachusetts, United States Digital Prospectors Full time
Quality Control Bioassay Consultant

Our client is seeking a highly skilled Quality Control Bioassay Consultant to join their dynamic team. This position offers an exciting opportunity to contribute to cutting-edge AAV-based gene therapy programs within a GMP-compliant environment.

Key Responsibilities:
  • Evaluate and approve cGMP analytical data for release and stability testing using bioassay test methods such as mRNA expression, functional potency, and ELISA testing platforms.
  • Perform data integrity reviews (data verification) to support validation, qualification, and analytical method trending reports as needed.
  • Support routine Laboratory Operations including, but not limited to:
  1. Review logbooks for reagent preparation, equipment, and critical reagent tracking.
  2. Conduct weekly laboratory housekeeping walkthroughs.
  3. Prepare reagents and perform cell passaging.
  • Author and support quality events including change controls, deviations, CAPAs, and OOS Investigations as required.
  • Author analytical method performance trend reports and other technical documents as needed.
Requirements:
  • Bachelor's degree in Cell Biology, Molecular Biology, Biochemistry, or a related discipline.
  • Minimum of 5 years of industry experience in a similar role.
  • Proven experience in mammalian cell culture and biological methods, including immunoassays, cell-based assays, and quantitative PCR.
  • Familiarity with GMP and GLP environments is essential.
  • Experience with statistical analysis software (i.e., SoftMax or JMP) is preferred.
  • Ability and enthusiasm to work in a fast-paced environment.
  • Strong collaboration, teamwork, and communication skills.
  • Independently motivated, detail-oriented, and adept at problem-solving.
  • Excellent interpersonal and organizational skills.

As a valued member of our team, you will have the opportunity to work with a dynamic and experienced group of professionals who are passionate about delivering high-quality results. If you are a motivated and detail-oriented individual with a strong background in bioassay methods, mammalian cell culture, and GMP practices, we encourage you to apply for this exciting opportunity.

At Digital Prospectors, we are committed to fostering a diverse and inclusive work environment that values creativity, innovation, and collaboration. We offer a competitive compensation package, including medical, dental, and vision benefits, as well as opportunities for professional growth and development.

Apply today and take the first step towards a rewarding career with our team



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