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CELL THERAPY QA SPECIALIST


M2Gen Building, 10902 N McKinley Drive, Tampa, FL 33612

Cell Thrpy Quality Prog

PRN (As Needed)

32

Day Shift

M-F 8-5

Bachelor Degree

Moffitt Cancer Center is internationally recognized for our focus on personalized cancer care and translational research. The mission of Moffitt is clear, focused, and fully stated in nine words, "To contribute to the prevention and cure of cancer." With a tradition of excellence that began with the first patient admission in 1986, dedicated Moffitt physicians, scientists, and staff members have remained committed to excellence in an atmosphere characterized by kindness, caring, and hope.

CELL THERAPY QA SPECIALIST (PRN - As Needed)

SUMMARY

The Quality Specialist works with the Quality Supervisor and Quality Management (QM) Director in developing and maintaining a Quality Management Program within the Cell Therapy Facility that results in the administration of safe and effective products to patients and clinical trial participants. The Quality Specialist will be responsible for ensuring adherence to the applicable regulations and standards (e.g., GMP, GTP, AABB, FACT, CAP, JCO). The Quality Specialist will assist with document control, deviation maintenance, and overall documentation compliance for all of the Quality Management Program components.

QUALIFICATIONS

 

  • Education:
    • REQUIRED 
      • Bachelor's Degree (Medical Technology or related biomedical science or field)
    • PREFERRED
      • Master's Degree (Medical Technology or related biomedical science or field)
  • Minimum Experience
    • REQUIRED
      • Minimum of 3 years experience in a regulated clinical or manufacturing laboratory, a quality position or a combination of both.
      • Knowledge of GMP/GTP regulations for pharmaceutical or biologics manufacturers and/or blood bank establishments.
      • Experience with patient/product safety, performance improvement, project management and working with medical staff.
      • Intermediate to advanced use of Microsoft Office ( Excel, Outlook, Word, Access, Powerpoint, Project Manager) preferred.
JOB COMPONENTS

 

  • Works within the cGMP and GTP guidelines and adheres to all regulatory standards within the Cell Therapy Facility.
  • Assists with the process of writing SOPs relevant to the Quality Management Program.
  • Participates in the maintenance of the document control system including the master hard copy of current SOPs.
  • Reviews documentation of maintenance, calibration and repairs performed on the facility and equipment.
  • Reviews quality documentation and releases incoming materials to be used in the production of cellular therapy products.
  • Designs and improves Quality related worksheets, templates and other documents.
  • Participates with the department staff in the investigation of quality events.
  • Monitors recalls that may affect supplies used in the production of cellular therapy products.
  • Assists in the collection and evaluation of necessary data to generate quality reports.
  • Assists in the performance of scheduled and unscheduled quality audits of cellular product processing/manufacturing records.
  • Collaborates in the performance of quality audits of vendors and other internal and external services providing support to the Cell Therapy Facility.
  • Moffitt Cancer Center is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, or protected veteran or disabled status. We seek candidates whose skills, and personal and professional experience, have prepared them to contribute to our commitment to diversity and excellence.