Cell Therapy Quality Management Specialist

At Moffitt Cancer Center, we strive to be the leader in understanding the complexity of cancer and applying these insights to contribute to the prevention and cure of cancer. Our diverse team of over 9,000 are dedicated to serving our patients and creating a workspace where every individual is recognized and appreciated. For this reason, Moffitt has been recognized on the 2023 Forbes list of America’s Best Large Employers and America’s Best Employers for Women, Computerworld magazine’s list of 100 Best Places to Work in Information Technology, DiversityInc Top Hospitals & Health Systems and continually named one of the Tampa Bay Time’s Top Workplace. Additionally, Moffitt is proud to have earned the prestigious Magnet® designation in recognition of its nursing excellence. Moffitt is a National Cancer Institute-designated Comprehensive Cancer Center based in Florida, and the leading cancer hospital in both Florida and the Southeast. We are a top 10 nationally ranked cancer center by Newsweek and have been nationally ranked by News & World Report since 1999.
Working at Moffitt is both a career and a mission: to contribute to the prevention and cure of cancer. Join our committed team and help shape the future we envision.

Summary

Cell Therapy Quality Management Specialist – Cell Therapy Quality Program

The Quality Management (QM) 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 Management Specialist will be responsible for ensuring adherence to the applicable regulations and standards (, GMP, GTP, AABB, FACT, CAP, JCO). The Quality Specialist will assist with record reviews, document control, deviation maintenance, and overall documentation compliance for all the Quality Management Program components. Other duties as assigned.

Key Duties & Responsibilities

• 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. Prior FDA, FACT, AABB or CAP inspection experience.
• Strong Oral and Written Communication skills. Members
• Intermediate use of Microsoft Office (Excel, Outlook, Word, Access, Powerpoint, Project Manager)
• Experience with CMC writing for IND applications preferred

Requirements

• Bachelor’s degree at minimum in Medical Technology or Related Biomedical science or related field
• Preferred ASCP, ASQ, Six Sigma Yellow Belt
• Minimum two (2) years’ experience in either a regulated clinical and/or manufacturing laboratory in a quality position