Document Control Specialist

Remote Jobs; Raleigh (NC); On-site; USD 55,000 - 90,000; Full time

Job summary

Talentify in Raleigh, NC seeks a Document Control Specialist to manage the creation, revision, approval, and archival of controlled documents, ensuring accuracy and regulatory compliance. You will maintain training records, support change management, and coordinate with cross-functional teams to keep the documentation system current.

The role requires experience with document management systems (Arena PLM preferred), strong attention to detail, and proficiency with Microsoft Office.

Qualifications

• Associate's or Bachelor's degree in a technical, business, quality, or related field preferred.
• 2-5 years of experience in document control or quality within a regulated industry.
• Experience with controlled documentation, quality records, and electronic document management systems.
• Knowledge of FDA QSR, ISO 13485; EU MDR and 21 CFR Part 11 is preferred.

Responsibilities

• Administer and maintain document control and training management systems (Arena PLM).
• Manage document lifecycle: submission, routing, review, approval, publishing, revision, archival.
• Maintain document master lists, revision histories, templates, and controlled records.
• Support Change Management and verify document changes for proper filing.
• Ensure obsolete documents are removed and only current, approved docs are available.
• Maintain training matrices, plans, and records; support training assignments.
• Provide user training on document management systems and electronic signatures.
• Support audits, regulatory inspections, and audit preparation with required records.
• Identify opportunities to improve document control processes and system usability.

Skills

Detail oriented

Time management

Communication

Team collaboration

Regulatory compliance

Education

Associate's or Bachelor's degree

Tools

Arena PLM

PLM

eDMS

ERP

Microsoft Office

Job 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.

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.