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.
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.
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.
SF:OMJ SF:OOD SF:RM SF:INS SF:IND; SF:INS
Internal Number: 36656-en_US
About University of Cincinnati
HISTORY IN BRIEF - The University of Cincinnati is a public urban serving research institution that was founded in 1819 and today is one of the country’s largest universities offering more than 350 academic programs to more than 44,000 students. UC has many top ranked programs in areas such as Music and Arts, Medical and Human-Services, Criminal Justice and more. Located in an urban setting, UC is close to the heart of Cincinnati and allows easy access for students to enjoy all that the city offers. UC is also the alma mater of many notables such as President William Howard Taft; Albert Sabin, developer of the oral polio vaccine; Astronaut Neil Armstrong and Mary Weinberg, 2008 Olympic gold medalist. UC is classified as a Research University (Very High Research Activity) by the Carnegie Commission and is ranked as one of America’s top 35 public research universities by the National Science Foundation. UC jumped 17 spots in the U.S. News & World Report rankings in the past two years alone. In addition to being named a “green university” by Princeton Review, UC has been named one of the world’s most beautiful campuses by Forbes and Delta Sky magazines. Learn more at www.uc.edu.MISSIO...N STATEMENT - The University of Cincinnati serves the people of Ohio, the nation, and the world as a premier, public, urban research university dedicated to undergraduate, graduate, and professional education, experience-based learning, and research. We are committed to excellence and diversity in our students, faculty, staff, and all of our activities. We provide an inclusive environment where innovation and freedom of intellectual inquiry flourish. Through scholarship, service, partnerships, and leadership, we create opportunity, develop educated and engaged citizens, enhance the economy and enrich our University, city, state and global community.