Documentation Change Specialist

The Documentation Change Specialist is responsible for managing, revising, and maintaining controlled documentation with a high degree of accuracy and efficiency. This role focuses 100% on documentation changes, supporting the business by ensuring that all updates, change orders, and customer-facing labeling revisions meet strict quality, compliance, and record-keeping standards. The specialist will work closely with site resources and must be adaptable when navigating sub-optimal or legacy systems.

This job description will be reviewed periodically and is subject to change by management.

ESSENTIAL DUTIES AND RESPONSIBILITIES – (KEY ACTIVITIES)

Documentation Revision & Control

• Review and revise controlled documents, including customer-facing product labeling, ensuring compliance with internal standards and accuracy requirements.
• Ensure all documentation updates are precise, complete, and free of errors.

Change Order Management

• Process and review documentation change requests with 100% accuracy, ensuring all modifications follow established procedures.
• Create and maintain Change Order Form records to document all approved changes.
• Track progress and manage a high volume of change requests efficiently and consistently.

Cross Functional Collaboration

• Collaborate effectively with onshore and local site teams to clarify, implement, and validate documentation updates.
• Work closely with resources who rely on older or less efficient systems, maintaining adaptability, patience, and problem-solving orientation.

Quality & Compliance

• Uphold all internal documentation standards, regulatory guidelines, and record-keeping requirements.
• Validate that final documentation meets accuracy and format expectations before release.

Qualifications & Skills

Required

• Experience revising and controlling documentation within a regulated or process-driven environment.
• Strong attention to detail with the ability to ensure 100% accuracy in all documentation.
• Ability to work efficiently under a high volume of documentation changes.
• Excellent written communication skills and the ability to follow structured documentation workflows.
• Adaptability and flexibility when working with older or less efficient systems.
• Strong collaboration skills and comfort working with cross-functional and site-based resources.
• Preferred
• Experience with change management systems or document control software.
• Background in manufacturing, healthcare, or any regulated industry (not required but beneficial).

Role Focus

• This role is narrow in scope but high in volume, with responsibilities centered exclusively on documentation changes. The specialist must maintain precision, consistency, and efficiency to support the business's operational needs.