GMP Stability Coordinator: Data & Trends Lead

Kiniksa Pharmaceuticals; Lexington (MA); On-site; USD 72,000 - 92,000; Full time

Job summary

Kiniksa Pharmaceuticals in Lexington, MA seeks a Stability Coordinator to manage GMP stability programs, trend stability data, and support QC records and regulatory filings. You will collaborate with Analytical Development, QC, Manufacturing, CMC, Validation, and Quality Systems to ensure data integrity and timely deliverables.

The role requires a BS in a scientific field with 3–5 years in GMP QC, experience with JMP or similar tools, and strong attention to detail, communication, and ownership

Qualifications

• BS in a scientific field with 3–5 years of experience in Quality Control in a GMP setting.
• Experience with JMP or similar statistical tools.
• Experience working with contract testing laboratories or external vendors in a regulated environment.
• Ability to review analytical data for completeness, accuracy, traceability, and compliance with procedures.
• Strong verbal and written communication and attention to detail.
• Familiarity with ICH stability guidelines and pharmaceutical regulatory expectations.

Responsibilities

• Oversee GMP stability programs, including tracking and trending of stability data and generation of reports.
• Maintain stability records and results within stability software for traceability.
• Collaborate with contract laboratories to ensure timely testing and delivery of QC deliverables.
• Review laboratory data for traceability and integrity and support stability-related decisions.
• Generate stability metrics to support annual reports, regulatory filings, and internal decisions.
• Coordinate shipping and sample management for stability testing activities.
• Drive process improvements and ensure inspection readiness for GMP stability work.

Skills

Project management

Cross-functional collaboration

Client engagement

Data interpretation

Education

BS in a scientific field

Tools

JMP

Job description

Kiniksa Pharmaceuticals in Lexington, MA seeks a Stability Coordinator to manage GMP stability programs, trend stability data, and support QC records and regulatory filings. You will collaborate with Analytical Development, QC, Manufacturing, CMC, Validation, and Quality Systems to ensure data integrity and timely deliverables.

The role requires a BS in a scientific field with 3–5 years in GMP QC, experience with JMP or similar tools, and strong attention to detail, communication, and ownership