Documentation Specialist - Department of Neurosurgery-GMP

Documentation Specialist I
- Department of Neurosurgery-GMP

Job No: 540983

Work Type: Full Time

Location: Main Campus (Gainesville, FL)

Categories: Education/Training/Instructional Design, Grant or Research Administration

Department:  - MD-NEUROLOGICAL SURGERY

Classification

Title:

Documentation Specialist I

Classification

Minimum Requirements:

Bachelor's degree in an appropriate area and one year of relevant experience or an equivalent combination of education and experience.

• Coordinate the lifecycle of controlled GMP documents, including creation, formatting, routing, review, approval, revision, distribution, and archival in accordance with facility Standard Operating Procedures (SOPs), Foundation for the Accreditation of Cellular Therapy (FACT) standards, and applicable regulatory requirements.
• Maintains document control systems, including document numbering, version control, electronic and paper filing systems, and document retrieval to ensure accuracy, accessibility, and compliance.
• Monitor document review schedules and coordinate periodic reviews and revisions with subject matter experts to ensure documentation remains current and compliant.
• Process and track quality system documentation, including Standard Operating Procedures (SOPs), forms, change controls, deviations, and other controlled records through established approval workflows.
• Remove obsolete documents from circulation and ensure current versions are available at points of use.
• Review completed documentation for accuracy, completeness, and compliance with established documentation practices prior to filing and archival.
• Maintain executed records in accordance with established record retention requirements and support document retrieval during internal audits, regulatory inspections, and accreditation reviews.
• Enter and maintain documentation data within electronic document management systems and other tracking databases while ensuring data integrity and confidentiality.
• Assist with identifying documentation discrepancies and coordinate corrective updates with appropriate personnel.
• Provide document control support to GMP personnel by responding to documentation requests and assisting with document-related processes to maintain inspection readiness and compliance with the Quality Management System.

• Coordination and records necessary to support compliance with Foundation for the Accreditation of Cellular Therapy (FACT) standards, Good Manufacturing Practice (GMP) requirements, and internal Standard Operating Procedures (SOPs).
• Assist in preparing, organizing, and maintaining documentation for quarterly Quality Assurance review meetings, accreditation activities, internal audits, and regulatory inspections.
• Compile and maintain quality metrics, reports, and support documentation for review by the Quality Management Manager, Medical Director, and UF GMP Facility Director.
• Coordinate the collection, organization, and submission of documentation required to support FACT accreditation and ongoing regulatory compliance activities.
• Assist with audit readiness by ensuring quality records, controlled documents, and supporting documentation are accurate, complete, and readily accessible.
• Collaborate with the UF GMP Facility Director, Medical Director, Quality Management Manager, and the CTSI Quality Assurance unit to support responses to audit findings, accreditation recommendations, and quality improvement initiatives.
• Track quality-related action items, documentation updates, and follow-up activities to ensure timely completion and compliance with established procedures.
• Maintain accurate records of accreditation, audit, and quality activities while supporting the continuous improvement of the Quality Management System.

• Support assigned Quality Management activities by coordinating training documentation, maintaining GMP compliance trackers, managing quality records, and assisting with routine quality system operations.
• Assist with the collection, tracking, and reporting of quality metrics to support Quality Management System monitoring and continuous improvement initiatives.
• Maintain accurate documentation and records related to training, compliance activities, and quality system processes in accordance with established procedures.
• Monitor assigned quality tracking tools and communicate documentation updates or outstanding items to appropriate personnel to support regulatory compliance and inspection readiness.

$61,350-$69,700

Bachelor's degree in an appropriate area and one year of relevant experience or an equivalent combination of education and experience.

3+ years of related experience in GMP Regulated environment.

• Working understanding of Quality Systems
• Experience with Documentation Control
• Good documentation practices

• Accuracy and attention to detail
• Strong organizational skills
• Proficient in…