Establish and maintain policies and procedures to ensure compliance with local, state and federal environmental regulations and standards including compliance with all Food & Drug Administration (FDA) and all other applicable global regulatory requirements.
The BMT Quality Assurance Specialist provides leadership, manages quality assurance activities, and monitors processes and regulatory compliance to meet the Foundation for Accreditation of Cellular Therapy.
This position actively participates in quality guidance, product resolution decisions and statistical problem solving techniques to New Product Development and project teams for process improvement and continuous improvement activities.
The BMT Quality Assurance Specialist will assist in creating and maintaining the blood and marrow transplant program's Quality Management Plan. The BMT Quality Assurance Specialist will establish systems to review, modify, and approve all policies and procedures intended to monitor compliance and performance of the clinical program.