Document Control Specialist

Job Summary:

Under the direction of the Regulatory and Quality Systems Manager, the Document Control Specialist is responsible for maintaining document and record control within the Quality Management System (QMS) in accordance with relevant regulations and standards such as FDA and ISO. The primary focus of this role includes document control, training administration tied to controlled documents, and quality record readiness to support audits and compliance.

Essential duties and responsibilities: 

· Maintain the QMS document control process (create, review, approve, issue, revise, archive, and control obsolete documents) in accordance with ISO 13485 and quality system requirements.

· Author, format, and publish QMS documents, specifications, forms, and work instructions using approved templates and standards.

· Execute document change requests, including routing for review/approval, tracking status, revision history, effective dates, and release.

· Maintain document indexes/master lists and document metadata (document number, title, owner, revision, effective date, status).

· Ensure current revisions are available at point of use and that obsolete versions are removed or clearly marked to prevent unintended use.

· Maintain the electronic Learning Management System (LMS) administration tied to controlled documents (assignments, tracking, retraining for revisions as applicable).

· Support control of quality records as assigned (e.g., production records, validation documents, labels/specifications, and other GMP documentation) to ensure completeness, retention, and retrieval.

· Support internal, customer, and external audits by retrieving controlled documents/records and demonstrating evidence of document control and training compliance.

· Support the generation of quality metrics related to document control and training (e.g., change request cycle time, overdue approvals, training completion).

· Develop quality meeting agendas; type and distribute meeting minutes as assigned.

 Assist with other QMS support duties as assigned.

Competencies:

Working knowledge of Microsoft Office Suite and comfort with electronic document systems.

Detail oriented with strong organizational skills and ability to manage multiple priorities.

Strong written communication and ability to work cross-functionally to drive timely approvals.

Ability to work with urgency, be accountable, cultivate collaboration, exemplify integrity, and foster teamwork.

Education 

Bachelor’s degree in a scientific or engineering discipline or an equivalent experience in a similar role

Experience and/or Training

0–2 years of experience in a Quality, Regulatory Affairs, or Document Control role in a regulated or manufacturing environment (GMP-related preferred).

Working knowledge of quality system standards (QSR/ISO 13485) preferred.