Quality Management System (QMS) Document Control Specialist

General Purpose

Responsible for supporting the Quality Management System (QMS) Document Control Supervisor in the controlled management of QMS documentation, including the logging, distribution, revision, control, storage, retrieval and maintenance of electronic and hardcopy quality documents (e.g. Policies, Procedures, Work Instructions, Forms) in compliance with FDA and ISO requirements.

Principle Accountabilities

• Support the QMS Document Control Supervisor in daily document control activities.
• Maintain controlled QMS documentation in accordance with approved procedures and regulatory requirements.
• Ensure documents are properly reviewed, approved, released, revised, and archived within the eQMS.
• Support Change Control activities for QMS documents, including tracking revisions and approvals.
• Assign document control numbers and maintain accurate version history, status, and traceability.
• Ensure document release packages are complete, accurate, and current.
• Support records control activities, including retention, retrieval, and audit readiness.
• Support internal, external, ISO, and FDA audits by retrieving documentation and providing objective evidence.
• Aid in continuous improvement initiatives related to document and configuration control processes.
• Collect and report document control metrics (e.g., review cycle times, on-time release).
• Proactively support department objectives and performance targets.

Minimum Required Qualifications

• Requires a High School Diploma or equivalent technical training
• 5+ years of experience in document control within a regulated (FDA/ISO) manufacturing or quality environment.
• Equivalent combinations of education, experience, and certifications will be considered.
• Strong understanding of FDA 21 CFR Part 820/QMSR, ISO 13485, and Good Documentation and Manufacturing Practices (GDP/GMP).
• Demonstrated experience managing the document lifecycle (creation, review, approval, release, revision, archiving).
• Hands-on experience with electronic Quality Management Systems (eQMS) (e.g., Compliance Quest, Agile).
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) and document formatting using approved templates.