Job Description

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.
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.
  
  

Expected Salary:

$61,350-$69,700

Required Qualifications:
Bachelor's degree in an appropriate area and one year of relevant experience or an equivalent combination of education and experience.
Preferred: EXPERIENCE
3+ years of related experience in GMP Regulated environment.
KNOWLEDGE
- Working understanding of Quality Systems
- Experience with Documentation Control
- Good documentation practices
SKILLS
- Accuracy and attention to detail
- Strong organizational skills
- Proficient in Microsoft Office (Excel and Word)
- Reliable
- Excellent communication skills
Special Instructions to Applicants:

Application must be submitted by 11:55 p.m. (ET) of the posting end date.

Health Assessment Required:
No