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Senior Quality Assurance Specialist

2 months ago


Woburn, Massachusetts, United States The Steely Group Full time
Senior QC Analyst Job Description

The Steely Group is seeking a highly skilled Senior QC Analyst to join our team in a dynamic environment. As a key member of our Quality Control team, you will play a critical role in supporting our AAV-based gene therapy programs.

Key Responsibilities:

  • Perform routine QC testing, including quantitative PCR and cell-based assays, in a GMP environment to support product release and stability.
  • Review and approve cGMP analytical data for release and stability testing from bioassay test methods, including mRNA expression, functional potency, and ELISA testing platforms.
  • Support and lead QC Bioassay laboratory operations, including instrument qualification and maintenance, cell passage, and critical reagent qualification.
  • Author and support quality events, such as change controls, deviations, CAPAs, and OOS investigations.
  • Support method transfer and validation activities for development, technical transfer, and validation of late-stage assays for AAV-based gene therapy programs.
  • Author analytical method performance trend reports as needed.
  • Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs).
  • Model leadership behaviors and mentor/train junior staff.
  • Work with cross-functional teams with both internal and external stakeholders.

Requirements / Qualifications:

  • BS in Cell Biology, Molecular Biology, Biochemistry, or a related discipline with a minimum of 5+ years of industry experience.
  • Experience in a GMP/GLP environment is a must.
  • Experience in routine mammalian cell culture is required.
  • Experience with quantitative PCR is required, and experience with cell-based potency assays is also required. Experience performing immunoassays such as ELISAs is strongly desired.
  • Experience with statistical analysis (SoftMax, JMP) is preferred.
  • Ability and desire to work in a fast-paced environment.
  • Strong collaboration, team-working skills, and communication skills.
  • Independently motivated and detail-oriented with good problem-solving ability.
  • Strong communication, interpersonal, and organizational skills.