Document Control Coordinator

ESSENTIAL RESPONSIBILITIES

• Maintains document compliance with ISO 13485 and FDA 21 CFR guidelines.
• Manages training set-up and record retention.
• Administers the annual training review process to ensure employee training records remain current.
• Responsible for overall coordination of controlled documentation within the company.
• Performs the Document Control function within the eQMS system.
• Supports user requests for documentation and trains users in eQMS system.
• Supports change management and ensures accurate and successful completion of document change requests.
• Supports the implementation of documentation, procedures, and specifications.
• Ensures compliance to document control, regulatory and training requirements.
• Affords support in reviewing document redlines and creating new documents.
• Verifies new and revised documents meet formatting and template standards prior to release.
• Tracks and maintains the distribution of hard copies, including issuance and reconciliation of logbooks.
• Assists in supporting external audits, coordinating activities, and ensuring timely response to documentation requests for auditors.
• Maintains quality records per applicable Standard Operating Procedures (SOP).
• Investigates and responds to corrective actions related to Document Control activities.
• Tracks performance metrics and prepares data for Management Review.

Qualifications

• Required: Experience with electronic document control and training system 2-5 Years Experience in the regulated industry.
• PREFERRED: Experience working with eQMS systems, Experience with FDA (21 CFR parts 4, 11, 210, 211, & 820), GMP, and ISO 13485.

Skills

• Experience with electronic document control and training system.
• Experience with FDA (21 CFR parts 4, 11, 210, 211, & 820), GMP, and ISO 13485.
• Experience working with eQMS systems.