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Quality Specialist, QMS
Amylyx Pharmaceuticals
Remote, USA
Full-time
Entry · 1+ years experience
Remote
USD 82000-92000 yearly / year
Discovered 1 weeks ago
eQMSVeeva Vault Quality DocsVeeva Vault Quality
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The Opportunity
The Specialist, Quality Management Systems (QMS) – Document Control is responsible for the administration, maintenance, and continuous improvement of the organization's document control processes within the Quality Management System. This role ensures the effective lifecycle management of controlled documents and records in compliance with applicable GxP regulations, company policies, and industry standards.
The Specialist serves as a key business partner to cross-functional teams, supporting the creation, review, approval, distribution, training, and archival of controlled documents while maintaining inspection readiness and promoting operational excellence across the organization.
We anticipate hiring the Quality Specialist, QMS in September 2026
Responsibilities
- Document Control Management Administer document control processes within the eQMS, ensuring effective lifecycle management of controlled documents and records in compliance with quality and regulatory requirements.
- Administer document control processes within the eQMS, ensuring effective lifecycle management of controlled documents and records in compliance with quality and regulatory requirements.
- eQMS Administration and Support Serve as the subject matter expert for document control processes within the eQMS, providing system administration, user support, and continuous improvement of document management functionality.
- Serve as the subject matter expert for document control processes within the eQMS, providing system administration, user support, and continuous improvement of document management functionality.
- Training Management and Compliance Coordinate and maintain document-related training activities and records to ensure compliance with quality system and regulatory requirements.
- Coordinate and maintain document-related training activities and records to ensure compliance with quality system and regulatory requirements.
- Compliance and Inspection Readiness Ensure document control and records management processes support compliance with applicable regulations, quality standards, and audit/inspection readiness requirements.
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