Documentation Coordinator

RESPONSIBILITY AND AUTHORITY

This position is responsible for processing new and changed documents through the controlled documentation system as well as maintaining the controlled documentation system. Other responsibilities include configuration management, document control, and/or enterprise system data entry. The incumbent performs these documentation responsibilities in accordance with documented procedures, quality standards, and regulatory requirements.


PRIMARY ACTIVITIES

• Performs activities relating to the document change control system, including file maintenance, database maintenance, document assignment, document accuracy and completeness checks, document incorporation and release, document copying, and document distribution
• Participates in programs designed to reduce the complexity of quality system processes and documentation within the bounds of meeting quality standards and regulatory requirements
• Ensures that customers’ documentation needs are met in an accurate and timely manner
• Performs other duties as may be required by the supervisor

ADDITIONAL ACTIVITIES

• Performs activities relating to Supplier Change Approval Notices
• Performs activities relating to document transmittal/distribution to off-site locations
• Assists in the implementation of the corporation’s quality goals and objectives
• Supports cost savings and quality initiative programs to enhance efficiency, productivity, and quality awareness
• Effectively communicates with company personnel, customers, subcontractors, regulatory agency representatives, and third party organizations

MINIMUM REQUIREMENTS AND QUALIFICATIONS

• High school diploma or equivalent
• Skilled in the use of Microsoft Office

DESIRED SKILLS AND QUALIFICATIONS

• Previous experience in an FDA regulated industry
• Excellent written and verbal communications skills
• Strong English language skills (e.g., spelling, grammar)

EXPERIENCE AND EDUCATION

Level 1 (Documentation Coordinator I) – High school diploma or equivalent and 1 to 2 years experience in document control or configuration management

Level 2 (Documentation Coordinator II) – High school diploma or equivalent and 2 to 5 years experience in document control or configuration management

Level 3 (Sr. Documentation Coordinator) - High school diploma or equivalent and 5 or more years experience in document control or configuration management