Quality Specialist, QMS

Amylyx Pharmaceuticals•Cambridge, MA

5h•$82,000 - $92,000•Remote

About The Position

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.

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 (eQMS), including experience with Veeva Vault Quality Docs/Veeva Vault Quality.
Working knowledge of Quality Management Systems (QMS), document control principles, records management, and Good Documentation Practices (GDocP).
Understanding of GxP regulations, data integrity requirements, and industry standards applicable to biopharmaceutical organizations.
Experience supporting quality audits, regulatory inspections, and compliance activities in a regulated environment.
Strong attention to detail, organizational skills, and ability to manage multiple priorities while meeting deadlines.
Strong analytical, problem-solving, written, and verbal communication skills, with the ability to work effectively across cross-functional teams.
Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, and Teams).

Nice To Haves

Certification in Quality, Records Management, or a related discipline.
Experience supporting eQMS implementation, validation, system administration, or continuous improvement initiatives.

Responsibilities

Administer document control processes within the eQMS, ensuring effective lifecycle management of controlled documents and records in compliance with quality and regulatory requirements.
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.
Coordinate and maintain document-related training activities and records to ensure compliance with quality system and regulatory requirements.
Ensure document control and records management processes support compliance with applicable regulations, quality standards, and audit/inspection readiness requirements.
Monitor document control performance, identify improvement opportunities, and support initiatives that enhance QMS effectiveness, compliance, and operational efficiency.