Apheresis Quality Specialist

Massachusetts General Hospital

  • Boston, MA
  • Permanent
  • Full-time
  • 19 days ago
Apheresis Quality SpecialistAre you passionate about ensuring the highest standards of quality and compliance in healthcare? Join our team at Massachusetts General Hospital (MGH) as an Apheresis Quality Specialist and play a crucial role in maintaining the integrity of our Apheresis unit.About Us: At MGH, we're dedicated to delivering exceptional patient care and advancing medical research. Our Apheresis unit is at the forefront of cellular therapy, and we're seeking a dynamic individual to ensure that our quality management practices meet and exceed regulatory standards.Role Overview: As the Apheresis Quality Specialist, you'll collaborate closely with our Medical Director and enterprise Pathology Quality leadership to develop, revise, and maintain our unit's quality management plan. Your expertise will be instrumental in integrating quality management plans for clinical trials and investigational products, ensuring compliance with regulations from agencies such as the FDA, FACT, AABB, CAP, CLIA, TJC, and the State of Massachusetts.Key Responsibilities:
  • Prepare the Apheresis Unit for regulatory site visits and audits.
  • Review quality agreements from research sponsors for potential new protocols.
  • Facilitate readiness for participation in new research protocols.
  • Serve as a resource and consultant for quality activities to the clinical oncology and apheresis programs.
  • Conduct audits to ensure the quality management system is operating effectively.
  • Analyze collected data and coordinate corrective action plans and quality improvement activities.
  • Review and approve training materials and competency assessments.
  • Qualify and approve suppliers of critical equipment.
  • Implement validation plans to ensure compliance with regulations.
  • Maintain the Document Control system for Apheresis.
  • Communicate with study principal investigators, IRB, and FDA as necessary.
QualificationsQualifications:
  • Bachelor's degree in a healthcare specialty required; Master’s preferred.
  • Registered Nurse, Clinical Laboratory Specialist, or Medical Technologist (ASCP) preferred.
  • 2-3 years of experience in a healthcare specialty required.
  • Experience in apheresis, cell therapy/stem cell transplantation, bone marrow transplant, hem/onc, laboratory medicine, and/or regulatory compliance/quality assurance preferred.
Join us at MGH and make a meaningful impact on patient care and safety through your commitment to quality and compliance in the Apheresis unit. Apply now to embark on a rewarding career journey with us!

Massachusetts General Hospital