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Quality Assurance Specialist

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Date: May 31, 2019

Location: Cincinnati, OH, US

The Quality Assurance Department at Hoxworth Blood Center provides regulatory and quality oversight for all processes at the Center. This position is for a Quality Assurance Specialist for the Cellular Therapies and Therapeutic Apheresis Departments.

 

Essential Functions

  • The Quality Assurance Specialist will be responsible for Cellular Therapy product release, batch record review and issuance.
  • The Quality Assurance Specialist 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.

     

The ideal candidate will

  • Have an understanding of Chimeric Antigen Receptor T Cells (CAR-T), and Virus Specific T Cells
  • Have experience with some or all of the following standards or regulations; cGMP, cGTP, AABB and FACT Standards.
  • Have worked in a clinical laboratory or FDA regulated environment.    
  • Have experience with Corrective Action/Preventive Action (CAPA), and tracking and trending to determine effectiveness of corrective actions.
  • Have knowledge of, or experience working with, Cleanrooms, the Investigational Review Board (IRB), Investigational New Drugs (IND), Pre-Market Approvals (PMA), and Biological License Approvals (BLA).
  • Have knowledge of, or experience in, Cellular Therapies Manufacturing and/or Apheresis Collections.

 

Minimum Qualifications

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.

 

The University of Cincinnati, as a multi-national and culturally diverse university, is committed to providing an inclusive, equitable and diverse place of learning and employment. As part of a complete job application you will be asked to include a Contribution to Diversity and Inclusion statement.

 

As a UC employee, and an employee of an Ohio public institution, if hired you will not contribute to the federal Social Security system, other than contributions to Medicare. Instead, UC employees have the option to contribute to a state retirement plan (OPERS, STRS) or an alternative retirement plan (ARP).

 

The University of Cincinnati is an Affirmative Action / Equal Opportunity Employer / M / F / Veteran / Disabled.

 

REQ: 36656 

SF:OMJ SF:OOD SF:RM SF:INS SF:IND; SF:INS


Nearest Major Market: Cincinnati

Job Segment: QA, Quality Assurance, Telecom, Telecommunications, Quality, Technology

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