CELL THERAPY MATERIALS EQUIPMENT DATA COORDINATOR in Tampa, Florida at H. Lee Moffitt Cancer Center
Explore Related Opportunities
Job Description
Cell Therapy Materials Equipment Data Coordinator
Position Highlights:
|
The Cell Therapy Materials & Equipment Data Coordinator is responsible for the comprehensive management of cell therapy materials, equipment records, and vendor listings within the Laboratory Information Management System (LIMS) and MasterControl. This role ensures strict compliance with FACT and FDA guidelines, supporting accurate documentation for quality release, inventory control, and operational readiness. The position requires meticulous attention to detail in tracking material quantities, lot numbers, expiration dates, receipt alignment with physical inventory, and maintaining equipment calibration and preventive maintenance schedules, including in-service and out-of-service status. |
Select Responsibilities:
Materials Management: Maintain accurate records of all cell therapy materials in LIMS, including: Specifications sheets for quality release, lot numbers, expiration dates, and quantities. Receipt documentation aligned with physical inventory. Preform routine reconciliation between LIMS data and physical inventory to ensure accuracy and compliance.
Equipment Management: Maintain a complete equipment inventory list in LIMS,
including: Calibration due dates and preventive maintenance (PM) schedules. Equipment status (in-service, out-of-service, or under maintenance). Ensure timely scheduling and documentation of calibration and PM activities in compliance with FACT and FDA requirements. Generate reports for audits and inspections detailing equipment readiness and compliance status.
Vendor Management: Maintain and update vendor listings in MasterControl, ensuring all approved suppliers meet compliance requirements. Track vendor qualifications, certifications, and documentation for FACT/FDA readiness. Collaborate with procurement and quality teams to ensure vendor records are current and accurate.
Compliance & Reporting: Ensure all documentation meets regulatory standards for
FACT and FDA inspections. Prepare and deliver accurate reports from LIMS and
MasterControl for internal quality reviews and external audits. Implement corrective actions for discrepancies in data or inventory records.
Credentials and Qualifications:
- Minimum of one (1) year experience in data information systems or cell therapy operations.
- Bachelor's Degree within Life Sciences, Biomedical Engineering, Information Systems, or related field.
- Proficiency in LIMS and MasterControl or similar data management systems.
- Strong understanding of FACT and FDA compliance requirements.
- Excellent organizational and documentation skills.
- Ability to work collaboratively in a fast-paced, regulated environment.
Preferred:
- Two (2) year experience in of experience in data information systems or cell therapy operations.
- Proficiency in LIMS and MasterControl or similar data management systems.
- Strong understanding of FACT and FDA compliance requirements.
- Excellent organizational and documentation skills.
- Ability to work collaboratively in a fast-paced, regulated environment.
- Familiarity with GMP/GTP environments.
- Strong analytical and problem-solving skills.
- Effective communication and vendor management experience.