Quality Control Specialist

Role: Stability Coordinator overseeing GMP stability programs within Kiniksa's Quality Control. Responsibilities include managing stability data trending, generating reports, collaborating with external labs, reviewing analytical results, and supporting regulatory submissions. The role involves process improvements, maintaining stability records, and ensuring inspection readiness. Requirements: BS in a scientific field; 3-5 years in GMP Quality Control; experience with stability data, statistical tools (JMP preferred), and external vendors; strong attention to detail and communication skills; knowledge of ICH stability guidelines and regulatory standards. HighValue: GMP stability programs, pharmaceutical product shelf-life, data trending, regulatory documentation, cross-functional collaboration in QC, CMC, and Validation. WorkSetup: onsite in Lexington, MA, five days per week.