Senior QA Specialist, GMP & Biologics (Onsite)

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

Job summary

Kiniksa Pharmaceuticals in Lexington, MA is seeking a Specialist / Senior Specialist, QA to provide QA support for manufacturing, quality control, and analytical development in batch disposition activities.

This onsite role involves reviewing GMP documentation, master and executed batch records, deviations, investigations, and change controls, plus collaboration with QA, RA and CMC teams to ensure timely approvals and data integrity.

Qualifications

• 4+ years in FDA-regulated pharmaceutical/biotech industry with GMP manufacturing operations, analytical development and quality.
• Experience with review of GMP manufacturing records (Master/Executed batch records, deviations, investigations, change controls).
• Biologics and Combination Products experience is a plus.

Responsibilities

• Oversee quality operations at internal and external service providers.
• Review and approve GMP documentation and batch records.
• Perform raw material release activities and QA review of lab data for release and stability.
• Collaborate with QA, RA, and CMC teams to support timely reviews.
• Support data integrity and continuous improvement in GMP activities.

Skills

QA experience

GMP knowledge

Veeva QualityDocs

Veeva QMS

Communication skills

Education

Bachelor's degree in a scientific discipline

Tools

Veeva QualityDocs

Veeva QMS

Job description

Kiniksa Pharmaceuticals in Lexington, MA is seeking a Specialist / Senior Specialist, QA to provide QA support for manufacturing, quality control, and analytical development in batch disposition activities.

This onsite role involves reviewing GMP documentation, master and executed batch records, deviations, investigations, and change controls, plus collaboration with QA, RA and CMC teams to ensure timely approvals and data integrity.