CambridgeFull TimeEngineering
Remotely
documentationauditdocument controlregulatoryquality management systemgxpeqmsgdocp
Job Description
📋 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
