Quality Control Specialist
Kiniksa Pharmaceuticals · Lexington, MA
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Kinikska Pharmaceuticals seeks a Quality Control Specialist to coordinate GMP stability programs in Lexington, MA. The role involves managing stability data tracking, collaborating with contract laboratories, reviewing laboratory results, and supporting shelf-life determinations for approved and investigational products. The position requires five days per week onsite and reports to the Associate Director of Quality Control.
What they're looking for
- Bachelor's degree in scientific field
- 3-5 years Quality Control experience in GMP environment
- Working knowledge of statistical tools and JMP software
- Project management and cross-functional collaboration skills
- Ability to interpret stability data and translate into actionable insights
What you'll be doing
- Oversee GMP stability program systems including data tracking, protocol generation, and quality record completion
- Maintain stability testing records in software systems ensuring traceability and data integrity
- Collaborate with contract laboratories to ensure timely testing completion and deliverable delivery
- Generate stability metrics and trends to support annual reports and regulatory filings
- Coordinate sample shipping and manage routine and non-routine testing activities
Privacy & handoff
This role links to Kiniksa Pharmaceuticals's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.