Document Services & Training Coordinator

Theragenics; Buford (GA); On-site; USD 52,000 - 72,000; Full time

Benefits offered by this job

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Job summary

Theragenics is seeking a Document Control Training Coordinator to manage EQMS documentation and change control. This role coordinates the Document Control department and training functions to align with medical device regulations, ensuring proper archiving, retrieval, and revision history.

Responsibilities include issuing ECNs, maintaining current document versions, conducting monthly audits, and providing EQMS user training at all levels.

Qualifications

• Detail oriented, accuracy and consistency are essential.
• Strong organizational, communication and customer service abilities.
• Ability to multitask and work independently in a fast-paced setting.
• Familiarity with ISO 13485 and cGMP compliance.

Responsibilities

• Coordinate changes to controlled documents and their release/distribution.
• Process ECNs in line with regulatory and company requirements.
• Maintain revision history and archive prior revisions.
• Ensure access to current document versions.
• Conduct monthly audits of manufacturing/quality areas for document status.
• Manage Quality Logs and periodic reviews of open items.
• Notify appropriate personnel for timely reviews (3-year cycle).
• Coordinate archival, storage, and destruction per retention policy.
• File and retrieve active quality records in Document Control.
• Provide back-room audit support during FDA/Corporate inspections.
• Train all employees and maintain EQMS curricula; deliver user training.

Skills

Detail oriented

Organization skills

Communication skills

Customer service skills

Multitasking

Independence

Problem solving

Ability to follow instructions

Education

High School Diploma

Associate degree or higher

Tools

Microsoft Word

Microsoft Excel

Job description

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.

Document Control Training Coordinator

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