Quality Specialist

• Serve as a subject matter expert for Quality Systems, supporting their effectiveness, compliance, and continuous improvement
• Support administration, maintenance, and optimization of Veeva QualityDocs, Veeva QMS, and ComplianceWire
• Execute and support risk-based supplier management activities, including vendor qualification, performance monitoring, and audit coordination
• Author, review, and manage GMP documentation, including SOPs, work instructions, and training materials
• Partner cross-functionally to implement, maintain, improve, monitor, and report on quality and compliance processes
• Support Quality Operations activities, including record reviews, disposition support, and Quality Event assessments
• Assist with internal and external audits, inspections, and follow-up activities
• Identify process enhancements and contribute to initiatives that strengthen Quality Systems and compliance performance
• Advance EDIT-401 into the clinic by maintaining, enhancing, and supporting phase-appropriate quality systems and vendor management processes

Quality Specialist jobs in Massachusetts

Senior Specialist, Quality Systems Management