Document Control Specialist

Job Description

Job Description

The Document Control Specialist is responsible for the lifecycle management of controlled documents to ensure accuracy, consistency, traceability, and compliance with company procedures and applicable regulatory standards. This role serves as a key support function within the Quality Management System (QMS) and works closely with Quality Assurance, Engineering, Manufacturing, Regulatory Affairs, and other cross-functional teams to ensure documentation is current, properly approved, and audit-ready at all times.

Essential Functions :

1. Administer the creation, review, approval, revision, and obsolescence of controlled documents, including SOPs, work instructions, forms, templates, specifications, and records.

2. Ensure documents follow established formatting, numbering, naming, and version control standards.

3. Maintain electronic documents, physical documents and archives.

4. Verify that only current, approved documents are available at points of use.

5. Control distribution of documents and ensure acknowledgment or training requirements are met.

6. Coordinate document change requests and ensure timely processing through approval workflows.

7. Track document status, revision history, and effective dates.

8. Ensure obsolete or superseded documents are promptly removed from use and archived per retention requirements.

9. Maintain traceability between related documents, records, and change controls.

10. Ensure documentation complies with applicable regulatory and quality standards (e.g., ISO 9001, ISO 13485, FDA QSR, GMP).

11. Support internal and external audits by retrieving documentation, preparing audit packages.

12. Identify documentation gaps, inconsistencies, or compliance risks and escalate as needed.

13. Assist in continuous improvement of document control procedures and workflows.

14. Manage quality records such as training records, batch records, device history records (DHRs), and device master records (DMRs), as applicable.

15. Ensure proper retention, storage, retrieval, and disposal of records according to company and regulatory requirements.

16. Maintain confidentiality and data integrity for sensitive and proprietary information.

17. Support training activities by ensuring training materials are current and controlled.

18. Assist with tracking employee training completion related to document changes.

19. Provide guidance to document authors and stakeholders on document control requirements and best practices.

20. Conduct document control training for new hires or refresher sessions as needed.

21. Track and report document control metrics, such as document cycle times, overdue reviews, and change request status.

22. Maintain logs, dashboards, and reports to support management review and audit readiness.

23. Read, understand and follow procedures.

24. As required, communicate the creation or modification of documentation.

25. Provide administrative assistance to the QA Manager.

26. Communicate with co-workers at all levels.

27. Read analyze and interpret business periodicals, technical procedures or government regulations.

28. Write reports, business correspondence and procedures.

29. Present information and respond to questions from groups of managers, clients, customers and general public.

30. Ability to work independently to manage multiple documents, deadlines, and priorities simultaneously.

31. Maintain accuracy, consistency, and attention to detail in a fast-paced, regulated environment.

32. Maintain workplace in a clean, safe, and orderly manner.

33. Required to be present in the workplace during scheduled work hours.

Marginal Functions :

Participate in other work functions as directed.

Physical Demands :

The employee is regularly required to sit, stand, walk, use hands and fingers for keyboard, phone and to handle or feel. Frequently required to reach with hands or arms, talk, hear, grasp, push, pull, and occasionally lift up to 35 lbs. Work is normally performed in an office environment but may occasionally require being around equipment or in a warehouse environment. Normal 20 / 20 vision (corrected if needed) required.

Qualifications and Requirements :

Education :

• High School Diploma or GED required
• Some college preferred

Skills and Abilities :

1. Ability to communicate effectively, both orally and in writing.

2. Ability to read, understand and accurately complete documentation in English.

3. Ability to effectively communicate in English to customers and employees.

4. Ability to function in a regulatory compliant manufacturing environment.

5. Ability to be flexible in changing workload priorities.

6. Must maintain accuracy, consistency and quality in a fast-paced environment.

7. Ability to accurately perform detail-oriented work.

8. Ability to add, subtract, multiply, and divide using imperial and metric measurements.

9. Strong understanding of document control principles, change management, and records retention.

10. Working knowledge of ISO and FDA regulatory requirements preferred.

11. Excellent attention to detail with ability to maintain accuracy across large volumes of documentation.

12. Strong organizational and time-management skills.

13. Effective written and verbal communication skills.

14. Proficiency in Microsoft Office and document management tools.

15. Ability to learn new software.

Experience :

Training :

Training requirements for this position are listed in the Required Employee Training Matrix.

This job description contains only the essential functions necessary to evaluate the position and is not an exhaustive list of all responsibilities or requirements.