Job Description

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

Theragenics Corp

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