Document Services & Training Coordinator

Document Control Training Coordinator

Responsible for the Management of the EQMS (QCBD). Coordinates the document and change control function as required by applicable medical device regulations. Ensures an effective system exists for identifying, indexing, obsoleting, archiving, and retrieving records required by the quality system. Performs day-to-day functions of the Document Control department. Coordinates the Training function as required by applicable medical device regulations.

JOB DUTIES

• Coordinates changes to controlled documents:

• Coordinate the activities of Document Control, including the tracking, release, distribution of controlled documents.

• Issue and process Engineering Change Notice and Approval (ECNs) according to regulatory and company requirements

• Maintain revision history through archival of ECNs and prior document revisions

• Maintain employee access to current versions

• Conducts monthly audit of all manufacturing/quality areas to ensure all updated or obsoleted documents are removed.

• Maintain status of Quality Logs including periodic review of open/pending items

• Ensure notification and timely (three-year) review of procedures through email notification to appropriate personnel

• Maintains control of Quality Records:

• Coordinate the archival, storage and destruction of records in accordance with the company’s record retention policy

• Coordinate filing and retrieval of active quality records maintained in the Document Control area.

• Provides back room audit support during FDA and Corporate inspections.

• Other duties as required

• Training Coordinator:

• Maintain Training curricula for all employees

• Coordinate Training notifications for new or modified documents

• Perform periodic review of Training Logs and associated monthly reporting.

• Provides EQMS user training for all levels, including View Only, Reviewer/Approver and PowerUser.

• Participates in departmental/process improvement projects as required.

QUALIFICATIONS

• Detail oriented, committed to accuracy, efficiency and consistency

• Strong organization skills are a must

• Strong communication and customer service skills

• Ability to multitask efficiently

• Ability to be flexible in a fast-paced environment

• Ability to work independently with minimal supervision

• Ability to apply common sense understanding to carry out instructions furnished in oral or written form

• Ability to tackle practical job-related problems or recognize the need to ask supervision for assistance.

EDUCATION OR TRADE KNOWLEDGE

• High School Diploma required; Associate degree or higher education preferred

• 3-5 years’ relevant work experience.

• Demonstrated proficiency in Microsoft Word and Excel

• Familiarity with ISO 13485 and cGMP