Quality Assurance Specialist

Found in: beBee jobs US - 3 weeks ago


Montgomery, Alabama, United States Department Of Health And Human Services Full time
Summary

The Quality Unit within the CCE is responsible for ensuring the safety, quality, purity, potency, and effectiveness of all services and activities in the CCE and for ensuring the reliability of services and data is in accordance with accrediting and regulatory agency requirements including NIH, USP, FDA, and TJC. The incumbent serves as a Quality Assurance Specialist (Hematopoietic) responsible for the Quality Assessment/Improvement (QA/I) program for hematopoietic stem cells in the CCE.



Duties

As a GS Quality Assurance Specialist (Hematopoietic Stem Cell Therapy), your duties may include but are not limited to the following:

  • Administering the hematopoietic stem cell quality program in the CCE including process control, document control, equipment validation, systems monitoring, document management, environmental monitoring, and personnel training and competency.
  • Ensuring that CCE activities are in compliance with AABB (Association for the Advancement of Blood and Biotherapies), Federal Drug Administration (FDA), and other standards related to the processing, storage, and infusion of hematopoietic stem cells.
  • Serving as the primary CCE point of contact for accreditation applications and inspections with the AABB, other accrediting organizations or entities for off-site manufacturing protocols.
  • Coordinating activities related to inspections and audits of the CCE by the AABB, other accrediting organizations, or entities for off-site manufacturing protocols.
  • Ensuring patient reactions related directly to the infusion of hematopoietic stem cell products, cell therapies, and gene therapies are appropriately documented and appropriately reported.

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