Document Control Analyst

Position Summary

The Document Control Analyst administers and manages the Document Control system within the electronic Quality Management System (eQMS), ensuring compliance with regulatory requirements and supporting quality, regulatory, laboratory, and manufacturing operations through document lifecycle management and continuous improvement.

• Administer and maintain the Document Control system to ensure compliance with applicable domestic and international regulations/standards (e.g., FDA, CAP/CLIA, ISO 13485, ISO 15189).
• Manage document lifecycle activities: creation, revision, approval, distribution, and archival of controlled documents.
• Maintain physical and electronic files for active and archived QMS records.
• Prepare and coordinate documentation for internal audits, client audits, and regulatory inspections.
• Provide guidance on QMS documentation requirements to internal stakeholders.
• Collaborate cross-functionally to ensure timely completion and approval of document revisions.
• Identify process improvements in document control workflows and support implementation.
• Provide guidance and training on document control procedures, system usage, and regulatory expectations.
• Coordinate with Quality Assurance, Regulatory Affairs, Manufacturing, Laboratory Operations, IT, and others to implement changes.
• Support periodic reviews of document management procedures and recommend improvements.
• Maintain electronic and physical records in accordance with record retention requirements.

• 1-3 years of experience in document control or quality systems in a regulated environment.
• BS/BA in a science-related field (or equivalent experience).
• Experience working in an eQMS.
• Proficient in Microsoft Office (Word, Excel, Outlook) and basic Internet for business use.
• Strong organizational skills; ability to manage multiple priorities and deadlines.
• Excellent written and verbal communication.
• Strong attention to detail; ability to maintain accurate records.

• Working proficiency in eQMS.
• Knowledge of FDA, CAP/CLIA, EU regulations, and ISO standards.
• Strong proofreading and document formatting skills (new docs, revisions, obsolescence).
• Ability to work independently with minimal supervision in a fast-paced environment.
• Ability to interpret regulations/guidance and apply critical thinking.
• Experience in continuous improvement/operational excellence initiatives.