Ensuring that the facility establishes, implements, and maintains a quality system that meets the FDA requirements and recommendations and AABB standards as well as other applicable regulatory and accreditation requirements. Managing cellular therapy laboratory documents including implementation, distribution, periodic review/revision, and archival. Conduction internal audit, preparing written reports of the findings and presenting the report.

Staying abreast of regulatory requirements applicable to all areas of the cellular therapy services, including a review of each new edition of regulatory and /or accreditation standards. Review and approve written procedures for production and process control, including any changes to these procedures. Review and approve all HPC-C production and control records to determine compliance with all established, approved, written procedures before a lot is released for distribution.

Minimum 2 years experience in cellular-therapy quality management system. Must have experience and maintaining compliance AABB, NMDP, FDA

Send resume to llawson@csccaz.com