Quality Specialist, QMS

📋 Description

• Administer document control processes within the eQMS, ensuring lifecycle management of controlled
• Serve as the subject matter expert for document control within the eQMS, providing system
• Coordinate and maintain document-related training activities and records to ensure compliance with
• Ensure document control and records management processes support compliance with applicable
• Monitor document control performance, identify improvement opportunities, and support initiatives

🎯 Requirements

• Bachelor's degree
• 1-3 years in pharmaceutical/biotech Quality (GMP environment)
• Experience managing controlled documents and records within an electronic Quality Management System
• Working knowledge of Quality Management Systems (QMS), document control principles, records
• Understanding of GxP regulations, data integrity requirements, and industry standards applicable to
• Experience supporting quality audits, regulatory inspections, and compliance activities in a

🎁 Benefits

• Remote work opportunities within the United States
• Travel to corporate location in Cambridge, MA several times a year
• Equal opportunity employer; accommodations available in our selection process