Document Control Coordinator

Job Details

• Responsible for maintaining 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.
• Support the implementation of documentation, procedures, and specifications.
• Ensures compliance to document control, regulatory and training requirements.
• Assist with review of document redlines and creation of new documents.
• Verifies new and revised documents meet formatting and template standards prior to release.
• Track and maintain the distribution of hard copies, including issuance and reconciliation of logbooks.
• Assist in supporting external audits, coordinating activities, and ensuring timely response to documentation requests for auditors.
• Investigates and responds to corrective actions related to Document Control activities.
• Track performance metrics and prepare data for Management Review.

Pay Range: $30-$36 per hour

• Experience with electronic document control and training system
• 2-5 Years Experience in the regulated industry

• Working knowledge of FDA (21 CFR parts 4, 11, 210, 211, & 820), GMP, and ISO 13485.
• Experience working with eQMS systems.

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.