QC Analyst

$114,400 - $124,800/Yr

Innova Corporation Co. Ltd - Woburn, MA

Full-time - Mid Level

Woburn, MA

10,001+ employees

Specialty Trade Contractors

About the position

The QC Analyst position at Innova Solutions is a full-time contract role focused on supporting AAV-based gene therapy programs within the Gene Therapy Quality Control Bioassay group. The Senior QC Analyst will engage in various quality control activities, including performing cell-based bioassays and ELISAs in a GMP environment, reviewing and approving data from external laboratories, and authoring technical documents. This role requires collaboration with cross-functional teams and mentoring junior staff, ensuring compliance with quality standards and supporting method validation and transfer activities.

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.
• Support and lead QC Bioassay laboratory operations, including instrument qualification and maintenance.
• Author and support quality events such as Change controls, Deviation, CAPA, and OOS Investigation.
• Support method transfer and validation activities for 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

• BS in Cell Biology, Molecular Biology, Biochemistry or a related discipline with minimum 5+ years industry experience.
• Experience in a GMP/GLP environment is a must.
• Experience in routine mammalian cell culture required.
• Experience with quantitative PCR required.
• Experience with cell-based potency assays is required.
• Experience performing immunoassays such as ELISAs strongly desired.
• Experience with statistical analysis (SoftMax, JMP) preferred.

Benefits

• Medical & pharmacy coverage
• Dental/vision insurance
• 401(k)
• Health saving account (HSA)
• Flexible spending account (FSA)
• Life Insurance
• Pet Insurance
• Short term and Long term Disability
• Accident & Critical illness coverage
• Pre-paid legal & ID theft protection
• Sick time
• Employee Assistance Program (EAP)