Document Control Specialist - Remote

Overview

The Document Control Specialist serves as a function within the organization’s Quality Management System (QMS) carrying responsibility for ensuring the integrity, control, traceability, and regulatory compliance of all controlled documentation supporting clinical research operations such as Policies, Standard Operating Procedures, Work Instructions, Templates, Forms, and Training Materials.

In Short

• Administer Clinilabs’ document control system for GxP documentation.
• Maintain document version control and ensure compliance with established procedures.
• Manage document review and approval workflows.
• Track periodic reviews of documents for completeness and compliance.
• Ensure compliance with global standards like FDA and ISO.
• Manage user access and permissions in quality software programs.
• Support internal audits and regulatory inspections.
• Identify and escalate document control deviations.

Requirements

• Bachelor’s degree in a relevant area or equivalent experience.
• Ability to work independently and coordinate documentation activities.
• Effective communication across various departments.
• 5+ years of experience in Quality Management Systems.
• Experience with computerized systems and data integrity principles.

Benefits

• Competitive salary range.
• Opportunity to work in a remote environment.
• Engagement in quality assurance and regulatory compliance.
• Support for professional development in clinical research.