Stability QC Specialist, GMP Data & Trending

Regulatory Toolkit; Lexington (MA); On-site; USD 72,000 - 92,000; Full time

Job summary

Kiniksa Pharmaceuticals in Lexington, MA is seeking a Stability Coordinator to lead GMP stability programs and support data trending across multiple functions including Analytical Development, QC, Manufacturing, CMC, and Validation.

Onsite five days a week, you will generate stability reports, review data for traceability, and drive continuous process improvements to support shelf-life determinations and regulatory filings.

Qualifications

• BS in a scientific area required.
• 3–5 years of quality control experience in a GMP setting.
• Experience with JMP is a plus.
• Experience coordinating with contract labs or external vendors is preferred.
• Strong communication and attention to detail.

Responsibilities

• Oversee GMP stability programs, tracking data and generating reports.
• Review and ensure traceability and integrity of laboratory data.
• Collaborate with internal and external partners to meet testing timelines.
• Generate stability metrics for annual reports and regulatory filings.
• Drive process improvements and ensure ISO/GMP readiness for the area.

Skills

Project management

Cross-functional work

Data interpretation

Communication

Education

BS in science

Tools

JMP

Job description

Kiniksa Pharmaceuticals in Lexington, MA is seeking a Stability Coordinator to lead GMP stability programs and support data trending across multiple functions including Analytical Development, QC, Manufacturing, CMC, and Validation.

Onsite five days a week, you will generate stability reports, review data for traceability, and drive continuous process improvements to support shelf-life determinations and regulatory filings.