Document Control Coordinator

Job Description:

Position Summary:
The Document Control Specialist is a quality focused individual who ensures all documentation and records are maintained and tracked within the Document Control and Management Systems while maintaining that the processes conform to regulatory requirements. The individual is responsible for the day-to-day operations of the documentation and document change control processes; including but not limited to document revision process, change control board, and records archival. This position will support periodic self-audits, internal audits, and regulatory inspections. In addition, the Document Control Coordinator will support various administrative tasks for Quality Assurance department.

• Maintain control of all hard copy and electronic controlled documents (scan, index, link, distribute, and file).
• Maintain Quality logs and generate department and other quality metrics
• Responsible for overall coordination of controlled documentation within the business unit.
• Supports all departments in documentation related matters in accordance and compliance with all applicable procedures.
• Train personnel on the document change control process and documentation handling practices.
• Release approved, changed documents according to the established standard operating procedures.
• Support and assists with the implementation of documentation changes
• Participates in and drives the continuous improvement of the Document Management processes.
• Exhibits flexibility and adaptability by managing assignments in accordance with project priorities and by altering course of action when and where necessary.

• BS in Engineering or Admin related career.
• Quality professional with 2+ year of experience with direct document control coordination in a regulated industry (medical industry preferably)
• Detail oriented.
• English intermediate level.
• Strong verbal, written, organizational, time management and interpersonal skills.
• Strong computer skills, including working knowledge of MS Office and e-mail
• Self-starting and the ability to focus on task at hand
• Ability to work independently with multiple departments to resolve Document Control issues.

• Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.
• Identifies and resolves problems in a timely manner
• Works well in group problem-solving situations
• Communicates changes effectively
• Builds commitment and overcomes resistance
• Looks for ways to improve and promote quality
• Demonstrates accuracy and thoroughness.