Document Services & Training Coordinator

ADP

Buford (GA)

On-site

USD 55,000 - 75,000

Full time

4 days ago
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Job summary

ADP in Buford, GA is seeking a detail-oriented Document Control professional to manage EQMS (QCBD) and oversee the document control process in compliance with medical device regulations. You will coordinate training, maintain revision histories, issue ECNs, archive quality records, and support FDA inspections while contributing to process improvements across the department.

The role requires 3–5 years of relevant experience and proficiency with Microsoft Word and Excel; a high school diploma is

Qualifications

  • Detail oriented, accurate, and efficient.
  • Must have strong organizational skills.
  • Proficient in Microsoft Word and Excel.
  • 3–5 years of relevant work experience.

Responsibilities

  • Coordinate changes to controlled documents and revisions.
  • Track and release controlled documents to ensure current versions.
  • Process Engineering Change Notices (ECNs) per regulatory requirements.
  • Maintain revision history and archival of ECNs and revisions.
  • Coordinate training notifications and maintain training logs.
  • Support FDA inspections with back room audit activities.

Skills

Detail oriented
Organization skills
Communication skills
multitask
Flexibility
Independent work

Education

High School Diploma
Associate degree or higher

Tools

Microsoft Word
Microsoft Excel

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Full Time Individual Contributor Buford, GA, US

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
  • 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
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