Senior QA Specialist, GMP Compliance & Release

Kiniksa Pharmaceuticals; Lexington (VA); On-site; USD 108,000 - 118,000; Full time

Job summary

Kiniksa Pharmaceuticals is seeking a Specialist/Sr. Specialist, QA to provide quality assurance support for manufacturing, QC, and analytical development in support of batch disposition. The role requires onsite work at the Lexington, MA office five days a week.

You will review GMP documentation, batch records, deviations, investigations, and change controls, coordinating with QA, RA, and CMC teams to ensure timely approvals and data integrity across external CDMOs and internal operations.

Qualifications

• Bachelor's degree in a scientific discipline with 4+ years in FDA-regulated pharma/biotech with GMP
• Experience with GMP manufacturing records review (Master/Executed batch records, deviations, investigations)
• Hands-on lab testing and method validation experience
• Familiarity with cell banks, drug substance/product testing is a plus

Responsibilities

• Oversee QA support for internal/external manufacturing and QC
• Review and approve GMP documentation from service providers
• Review batch records and packaging records for drug substances/products
• Support batch disposition activities and data entry in quality systems
• Collaborate with QA, RA, CMC teams to ensure timely approvals
• Ensure data integrity and audit trails

Skills

QA experience

GMP environment

Communication skills

Regulatory standards

Education

Bachelor's degree in science

Tools

Veeva QualityDocs

Veeva QMS

Job description

Kiniksa Pharmaceuticals is seeking a Specialist/Sr. Specialist, QA to provide quality assurance support for manufacturing, QC, and analytical development in support of batch disposition. The role requires onsite work at the Lexington, MA office five days a week.

You will review GMP documentation, batch records, deviations, investigations, and change controls, coordinating with QA, RA, and CMC teams to ensure timely approvals and data integrity across external CDMOs and internal operations.