Document Control Specialist Sample Job Descriptions

Position Overview

The document control clerk provides administrative support for document management processes by handling intake, formatting, filing, and basic tracking of controlled documents. This entry-level role ensures data is accurately recorded and documentation is accessible to authorized personnel.

Responsibilities

• Receive, log, and file incoming documents and change requests
• Scan, label, and archive paper and digital files per naming conventions
• Enter metadata and update document databases
• Ensure controlled documents are routed to appropriate stakeholders
• Support internal staff with document retrieval or status updates
• Perform periodic audits to verify document completeness and consistency

Requirements

Hard skills

• Basic knowledge of document management systems (e.g., SharePoint, DocuWare)
• Proficiency in Microsoft Word, Excel, and PDF editing tools
• Accurate data entry and file-naming skills

Soft skills

• Detail-oriented and organized
• Strong time management and multitasking ability
• Clear written and verbal communication
• Dependability and follow-through

Education

• High school diploma or equivalent

Preferred Qualifications

• Previous administrative or records management experience
• Familiarity with controlled documentation in regulated settings

Position Overview

The document control specialist manages the full lifecycle of internal documentation, ensuring accuracy, regulatory compliance, and version control. This role collaborates with multiple departments to maintain standardized workflows and support audits.

Responsibilities

• Process new and revised documents through review and approval workflows
• Maintain version histories and track document change requests
• Ensure adherence to formatting, metadata, and retention policies
• Support quality assurance and compliance teams with audit documentation
• Provide access to controlled documents and manage distribution lists
• Train internal users on document procedures and submission guidelines

Requirements

Hard skills

• Proficiency in document control platforms (e.g., MasterControl, SharePoint)
• Familiarity with version control and change management practices
• Understanding of ISO 9001, FDA, or GMP documentation standards

Soft skills

• Strong attention to detail and process discipline
• Collaborative team mindset with cross-functional communication
• Time-sensitive decision-making and prioritization
• Analytical thinking and workflow awareness

Education

• High school diploma required; associate’s degree preferred

Certifications

• None required
  ISO or quality documentation training is beneficial.

Preferred Qualifications

• 2+ years in document control, quality, or administrative roles
• Experience supporting regulatory or internal audits

Position Overview

The senior document control specialist leads complex documentation initiatives, ensures system integrity, and supports audit and compliance efforts. This role often supervises junior staff and collaborates with QA, engineering, or compliance leaders to uphold operational standards.

Responsibilities

• Lead complex document workflows and coordinate cross-departmental submissions
• Maintain DMS system integrity and user access permissions
• Review and approve formatting, compliance, and version control standards
• Conduct document audits and support FDA, ISO, or client inspections
• Train and mentor junior document control staff
• Recommend and implement improvements to document control procedures

Requirements

Hard skills

• Advanced knowledge of DMS tools and controlled document workflows
• Expertise in GMP, ISO, FDA 21 CFR Part 11, or other regulatory standards
• Document audit preparation and compliance tracking

Soft skills

• Project management mindset with leadership abilities
• Excellent attention to detail and document accuracy
• Confident cross-functional collaboration and policy enforcement

Education

• Associate’s or bachelor’s degree in a related field

Certifications

• ISO internal auditor certification or equivalent
  CDIA+ or Six Sigma certifications are also valuable in technical environments.

Preferred Qualifications

• 4+ years of document control or QA experience
• Experience managing audit documentation and DMS configurations

Position Overview

The document control manager oversees the company’s document control strategy, including policy development, DMS implementation, and team leadership. This role ensures enterprise-wide compliance with documentation standards and serves as the primary liaison for audit and regulatory inquiries.

Responsibilities

• Lead the development and enforcement of document control policies and SOPs
• Manage document control teams and oversee workflow efficiency
• Ensure company-wide compliance with regulatory and quality standards
• Maintain and optimize DMS platforms and user access roles
• Support internal and external audits, inspections, and certifications
• Collaborate with executive and department leadership on documentation strategy

Requirements

Hard skills

• Expertise in DMS administration and regulatory documentation standards
• Deep knowledge of ISO 9001, FDA, GMP, or industry-specific compliance
• Budgeting and planning for document control initiatives
• Audit leadership and cross-site document harmonization

Soft skills

• High-level leadership and decision-making ability
• Strategic thinking with strong process improvement mindset
• Effective training and performance coaching
• Executive-level written and verbal communication

Education

• Bachelor’s degree in quality, engineering, business, or operations

Certifications

• ISO Lead Auditor
• CDIA+, Six Sigma, or quality systems management certifications are strongly preferred

Preferred Qualifications

• 6+ years of document control experience, including team management
• Experience implementing or migrating enterprise document systems
• Regulatory audit leadership in a highly controlled environment