Document Control Specialist

Document Control Specialist

RALEIGH - RALEIGH, NC 27615

Overview

Position Type Full Time

Description

Position Summary:

The Document Control Specialist supports the organization, maintenance, and control of company documentation to ensure accuracy, accessibility, and compliance with applicable regulatory requirements. This role administers document control and training management processes, supports document changes and approvals, and collaborates with cross-functional teams to maintain an effective and compliant documentation system.

Duties & Responsibilities:

• Administer and maintain document control and training management systems, including Arena PLM.
• Manage the document lifecycle, including submission, routing, review, approval, publishing, revision, and archival of controlled documents.
• Maintain document master lists, revision histories, templates, and controlled records, including DHF, DMR, DHR, and other quality documentation.
• Support Change Management activities by verifying document changes and ensuring approved documentation is properly processed and filed.
• Ensure obsolete and superseded documents are removed from circulation and that only current, approved documents are available for use.
• Maintain training matrices, plans, and records; support training assignments and monitor completion.
• Provide user support and training on document management systems, electronic signatures, and document control processes.
• Support periodic document reviews and coordinate with document owners to ensure timely completion.
• Generate Document Control and training reports and track key metrics.
• Support internal and external audits, regulatory inspections, and audit preparation by providing required documentation and records.
• Support Quality System Software activities, including validation activities, as requested.
• Maintain external reference standards and support regulatory filing activities.
• Identify opportunities to improve document control processes, system usability, and compliance.
• Other duties as assigned or required.

Qualifications

Minimum Requirements & Qualifications:

• Associate's or Bachelor's degree in a technical, business, quality, or related field preferred.
• 2-5 years of experience in document control, quality assurance, or a related function within a regulated industry.
• Experience with controlled documentation, quality records, and electronic document management systems.
• Working knowledge of document control processes, including document revisions, change control, approval workflows, and archival requirements.
• Familiarity with FDA Quality System requirements and ISO 13485; knowledge of EU MDR and 21 CFR Part 11 preferred.
• Experience with PLM, ERP, eDMS, or other document management systems; Arena PLM experience preferred.
• Proficiency in Microsoft Office, particularly Word, Excel, and PowerPoint.
• Strong attention to detail, organization, and time-management skills.
• Strong written and verbal communication skills.
• Ability to manage multiple priorities and work effectively both independently and as part of a cross-functional team.
• Ability to work effectively in a fast-paced, regulated environment.