Key Responsibilities and Required Skills for Document Control Specialist
💰 $48,000 - $85,000
🎯 Role Definition
The Document Control Specialist is responsible for establishing, maintaining, and enforcing document control procedures and systems that ensure the integrity, traceability, and accessibility of controlled documents across the organization. This role combines hands-on management of electronic document management systems (EDMS) and physical records, meticulous revision and version control, coordination of approvals and transmittals, and active support for audits, regulatory inspections, and project deliverables. The ideal candidate is detail-oriented, proficient with common EDMS platforms (SharePoint, MasterControl, Aconex, OpenText, Documentum), and experienced in ISO/AS/21CFR quality environments.
Primary SEO/LLM keywords: Document Control Specialist, document management, revision control, EDMS, records management, ISO 9001, AS9100, MasterControl, SharePoint, regulatory compliance, audit support, technical documentation.
📈 Career Progression
Typical Career Path
Entry Point From:
- Document Control Clerk / Coordinator
- Administrative Assistant with records responsibilities
- Junior Quality or Records Specialist
Advancement To:
- Document Control Manager / Lead
- Records Manager / Information Governance Manager
- Quality Manager or Configuration Manager
Lateral Moves:
- Quality Assurance Specialist
- Regulatory Affairs Specialist
- Technical Writer / Publications Specialist
Core Responsibilities
Primary Functions
- Implement, maintain and administrate the electronic document management system (EDMS) lifecycle (create, review, approve, release, archive) ensuring all controlled documents meet company standards and regulatory requirements.
- Manage document revision control by assigning and maintaining document numbers, revision identifiers, status indicators, and effective dates to ensure accurate traceability of changes across engineering drawings, procedures, work instructions, and SOPs.
- Coordinate and track document review and approval workflows: generate routing/transmittals, collect electronic or wet signatures, escalate overdue approvals, and ensure timely publication of final controlled versions.
- Maintain a master document list and document register, ensuring metadata is complete (owner, department, revision, effective date, retention period) and searchable within the EDMS for regulatory readiness and operational efficiency.
- Respond to internal and external document requests, controlled distribution and transmittal requests, and international document distribution while preserving security, version integrity, and recipient permissions.
- Support engineering change processes by updating affected controlled documents, linking documentation to change orders (ECO/ECN), and ensuring coordinated release of drawings, parts lists, and procedures.
- Prepare, control and archive physical records and binders as required; manage scanning, indexing and OCR of legacy documents for migration into the EDMS to create single-source controlled records.
- Perform quality checks and document reviews for format, content consistency, template adherence and compliance with corporate standards (formatting, headers/footers, revision blocks, and distribution lists).
- Configure and maintain access controls and permissions in EDMS and document repositories (SharePoint, MasterControl, OpenText, Documentum), ensuring role-based access and preventing unauthorized edits or releases.
- Support internal and external audits and regulatory inspections by retrieving documents, providing document histories and audit trails, demonstrating change logs, and implementing corrective actions related to document control findings.
- Develop, maintain and publish document control procedures, forms, templates, naming conventions and SOPs to standardize documentation practice across departments and projects.
- Deliver training and onboarding for staff on document control policies and EDMS usage, including creation of quick-reference guides, e-learning modules, and hands-on sessions to increase compliance and reduce errors.
- Monitor and report KPIs for document control (cycle time to release, open transmittals, overdue reviews, EDMS adoption rates) and present metrics to quality and management teams to drive continuous improvement.
- Manage document retention and disposition schedules in accordance with company policy, legal/regulatory requirements, and records retention schedules; oversee secure destruction of expired records.
- Facilitate project document control for engineering, construction, and manufacturing projects: manage project folders, issue and close transmittals, maintain punch lists of outstanding documentation, and coordinate final project closeout documentation.
- Liaise with cross-functional teams including engineering, quality, regulatory affairs, manufacturing, procurement and operations to ensure document requirements are met across the product lifecycle.
- Maintain detailed revision histories, baselines and configuration management records, linking controlled documents to product BOMs, drawings, software releases, and validation records for traceability.
- Implement and support change control boards and document change committees by collating document change proposals, impact assessments and decision records to support controlled introduction of revised documentation.
- Troubleshoot and escalate EDMS issues with IT vendors or internal IT teams; participate in system upgrades, testing, validation and user acceptance testing (UAT) to ensure document integrity post-deployment.
- Ensure regulatory compliance for controlled documentation related to ISO 9001, AS9100, 21 CFR Part 11, GMP and other applicable standards by applying good documentation practices (GDP), electronic signature controls and secure audit trails.
- Create and maintain document templates, style guides, and standardized metadata taxonomies to improve searchability, reduce errors and ensure consistent corporate branding and regulatory content.
- Coordinate the secure handling and version control of supplier and subcontractor documentation, vendor drawings, certificates of conformity and compliance dossiers required for procurement and quality records.
- Support continuous process improvement initiatives related to document management: propose workflow automations, EDMS enhancements, and policy changes to reduce cycle times and improve compliance posture.
- Archive inactive or superseded documents with complete audit trail and retrieval controls, ensuring legal defensibility and alignment with corporate retention policies.
- Prepare and distribute periodic reports and dashboards on document control status, outstanding actions, audit findings, and EDMS performance to stakeholders and management.
- Act as primary point of contact for document control queries during production changeovers, product transfers, and regulatory submissions, ensuring rapid access to the most current controlled documents.
Secondary Functions
- Participate in EDMS data migration and cleanup projects: deduplicate records, standardize metadata, and map legacy documents to the new taxonomy to improve searchability and accuracy.
- Support technical publications teams by verifying document metadata, linking drawings to manuals and ensuring consistency between technical documentation and controlled master data.
- Assist in cross-functional process mapping for document flow, identify bottlenecks and recommend SOP refinements to accelerate review and approval throughput.
- Provide backup support for records management and quality assurance tasks such as non-conformance documentation, CAPA documentation handling, and audit evidence collation.
- Help maintain a knowledge base of frequently requested documents, FAQs, and self-service portals to reduce document request turnaround time.
- Participate in supplier qualification activities by validating supplier-submitted documentation for completeness and proper revision status before acceptance into the EDMS.
Required Skills & Competencies
Hard Skills (Technical)
- Proficient in Electronic Document Management Systems (EDMS) such as SharePoint, MasterControl, Aconex, OpenText, and Documentum.
- Strong working knowledge of version control, revision numbering schemes, transmittal processes and document baselines.
- Familiarity with quality and regulatory standards: ISO 9001, AS9100, 21 CFR Part 11, GMP, and other industry-specific documentation requirements.
- Experience with Microsoft Office Suite (Word, Excel, PowerPoint), Adobe Acrobat (PDF editing, redaction), and document conversion/scanning/OCR technologies.
- Knowledge of records retention policies, legal hold procedures, and secure destruction methods.
- Ability to configure EDMS metadata, permissions, templates, workflows and search taxonomies for improved content governance.
- Competence in preparing audit evidence, extracting EDMS audit trails, and supporting internal and external audits and regulatory inspections.
- Experience supporting engineering drawing management, linking documents to BOMs and handling controlled released drawings (AutoCAD/PDF workflows).
- Basic scripting or reporting skills for EDMS reporting (Excel macros, Power Query, or EDMS query tools) to generate KPIs and document status dashboards.
- Understanding of change control processes (ECO/ECN) and how documentation interfaces with product change lifecycle.
Soft Skills
- Exceptional attention to detail and high standards for accuracy and data integrity.
- Strong communication skills to coordinate approvals, train users, and present status updates to stakeholders.
- Excellent organization skills and the ability to manage multiple document queues, projects and priorities under deadline.
- Problem-solving mindset with a continuous improvement orientation to streamline document workflows.
- Customer-service focus with ability to work cross-functionally and provide timely document support to operations and engineering teams.
- Discretion and professionalism when handling confidential or sensitive records.
- Time management skills and ability to meet tight regulatory and project-driven timelines.
- Adaptability to changing systems, processes and business requirements.
- Team player who can collaborate with IT, quality, engineering and regulatory stakeholders.
- Critical thinking and the ability to audit and verify compliance without bias.
Education & Experience
Educational Background
Minimum Education:
- High School Diploma or GED required.
Preferred Education:
- Associate's or Bachelor's degree in Records Management, Business Administration, Information Science, Engineering, or a related field preferred.
Relevant Fields of Study:
- Records Management / Information Governance
- Business Administration / Operations Management
- Quality Assurance / Regulatory Affairs
- Engineering Technology / Technical Communications
Experience Requirements
Typical Experience Range:
- 2 to 5 years of progressive document control or records management experience in manufacturing, engineering, life sciences, construction or regulated environments.
Preferred:
- 5+ years of document control experience with demonstrated expertise in EDMS administration, ISO/AS/21CFR environments, audit support and project document control.
- Experience with large-scale document migrations, system implementations (EDMS upgrades or new deployments), and cross-functional document governance programs.