Quality Control Specialist
Kiniksa Pharmaceuticals
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.
Responsibilities
- 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
Requirements
- 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
Vacancy posted 6 days ago
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