Senior Quality Assurance Specialist

Responsibilities

• Oversee quality operations at the company and at external service providers (CDMOs/CTLs)
• Review and approve service providers' GMP documentation
• Review and approve master/executed batch records and packaging records for drug substances and drug product/finished drug product
• Perform GMP raw material release activities for internal manufacturing operations
• Review and approve laboratory data related to the release and stability of GMP materials, qualification of test methods and reference standards, including protocols, data, and reports
• Collaborate with external service providers and internally with QA, RA, and CMC teams to support the timely review and approval of documents
• Review records, including audit trails, and ensure the integrity of data and results generated by external CDMOs/CTLs
• Support batch disposition activities, including data upload, review, and documentation in applicable quality systems
• Compile data for quality system reviews

Qualifications

• Bachelor's degree in a scientific discipline with 4+ years of experience in the FDA-regulated pharmaceutical/biotech industry with GMP manufacturing operations, analytical development, and quality
• Experience in Biologics and Combination Products (Cell and Gene Therapy, monoclonal antibodies) preferred
• Experience with review of GMP manufacturing records (Master/Executed batch records, change controls, deviations, investigations, product complaints) associated with clinical programs
• Hands-on experience with laboratory testing and method validation

Schedule

Monday–Friday, 100% onsite, 9:00 AM – 5:00 PM.

Pay

$60.00 – $70.00 per hour. Individual compensation within this range depends on qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other job-related factors.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital coverage
• 401(k) Retirement Plan with pre-tax and Roth post-tax contributions
• Life Insurance (Voluntary Life & AD&D for employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Position Details

Contract role based in Lexington, MA (100% onsite). Intermediate experience level. Application deadline: November 18, 2026.