Apheresis Quality Specialist
Massachusetts General Hospital
- Boston, MA
- Permanent
- Full-time
- 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.
- 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.