| Job Description: |
Document Management:
- 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.
FACT Accreditation and Quality Activities
- 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.
Quality Management System (QMS) Support
- 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.
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