The Quality Assurance Department at Hoxworth Blood Center provides regulatory and quality oversight for all processes at the Blood Center.
The Quality Assurance Specialist will be responsible for Cellular Therapy product release, batch record review and issuance. This position will assist with the development of new and revised department Standard Operating Procedures (SOPs), perform audits, analyze data, report results, assist with process validations, and ensure compliance with applicable regulations.
Experience Must Include:
Working knowledge of some or all of the following standards or regulations; GMP, GTP, AABB and FACT Standards. Specifically, in a quality role such as QC, QA or Compliance.
Previous experience in a clinical laboratory, blood bank, pharmaceutical or other FDA regulated environment.
Previous experience with Corrective Action/Preventive Action (CAPA), root cause analysis and effectiveness checks.
Previous experience reviewing batch production records, label approval and product release.
The Ideal Candidate will have:
Working knowledge of cleanroom requirements and process validations.
Expertise in Cellular Therapies Manufacturing and/or Apheresis Collections.
An understanding of Chimeric Antigen Receptor T Cells (CAR-T), and Virus Specific T Cells
Knowledge of or experience working with the Investigational Review Board (IRB), Investigational New Drugs (IND), Pre-Market Approvals (PMA), and Biological License Approvals (BLA).
Bachelor’s degree with three (3) years experience;-OR-Associate’s degree with five (5) years experience;-OR- seven (7) years experience. Degree and experience must be in a related field. Experience may require at least one (1) year supervision.
Internal Number: 38683
About Hoxworth Blood Center
Hoxworth Blood Center, located in Cincinnati, Ohio, is an independent community blood center, owned and operated by the University of Cincinnati Academic Health Center. The University of Cincinnati Academic Health Center offers competitive compensation and a wide array of benefits that includes tuition remission for all eligible faculty, staff and dependents.