Specialist / Senior Specialist - Quality Assurance

Role: Senior Quality Assurance Specialist supporting manufacturing, laboratory, and quality control operations in a biopharma setting. Responsibilities: review and approve GMP documentation, batch records, deviation reports, change controls, and supplier notifications; perform GMP raw material release activities; oversee external service provider documentation; support batch disposition and quality system reviews; collaborate with internal teams and external vendors to ensure compliance and data integrity; contribute to continuous GMP improvements. Requirements: Bachelor's in a scientific discipline; 4+ years of experience in FDA-regulated pharma/biotech, with GMP manufacturing, analytical development, and quality oversight; hands-on experience in biologics and combination products (cell/gene therapy, mAbs) preferred; familiarity with GMP standards (21 CFR Parts 210-211, Part 11, EudraLex), Veeva QMS/QualityDocs, and laboratory testing/validation. High-Value: GMP oversight in biologics/combination products, batch record review, GMP raw material release, experience with FDA and international standards. Work setup: onsite five days/week in Lexington, MA.