Stability Data Specialist (GMP)

Location: Hybrid role based in Lexington, Massachusetts, USA, with occasional travel to the Cambridge, Massachusetts client site. Candidates must live within a commutable distance of Lexington.

Salary: $31.00–$35.00 per hour, based on education and related experience.

Company

International life sciences company providing analytical testing, laboratory, pharmaceutical, environmental, food, cosmetics, genomics, and clinical research services.

What you will do

• Review and interpret analytical and QC testing data from external vendor laboratories.
• Enter, verify, and trend GMP data in validated database systems.
• Build and manage stability studies and confirm alignment with current specifications.
• Prepare technical reports, regulatory documentation, regulatory submission tables, and Certificates of Analysis.
• Monitor reference standards and analytical data, escalating technical or vendor-related issues.
• Collaborate with internal departments, clients, and external partners to deliver assignments on time.

Requirements

• Bachelor’s degree in Chemistry, Biology, or a related field.
• At least two years of relevant industry experience.
• Required experience in Quality Control, Quality Assurance, or a GMP-regulated environment.
• Strong understanding of GMP principles and regulatory compliance.
• Clear technical documentation, communication, time management, and multitasking skills.
• Permanent authorization to work in the United States without restriction or sponsorship is required.

Nice to have

• Experience in Analytical Development.
• Familiarity with analytical methods for biologic or small molecule products.

Culture & Benefits

• Full-time Monday–Friday schedule, 8:00 a.m.–5:00 p.m.
• Medical, dental, and vision coverage.
• Life and disability insurance.
• 401(k) with company match.
• Paid vacation and holidays, annual goal-based bonus eligibility, and merit-based increases.