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Senior Quality Assurance Specialist
2 months ago
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.