Document Control Coordinator

Document Control Specialist

ESSENTIAL RESPONSIBILITIES

• 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.
• Maintains quality records per applicable Standard Operating Procedures (SOP).
• 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

Qualifications

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.

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