Quality Assurance Specialist (Cell Therapy), Hoxworth
Date: Mar 19, 2020
Location:Cincinnati, OH, US
Company: University of Cincinnati
Internal applicants must apply internally via SuccessFactors >
The University of Cincinnati is a premier, public, urban research university; ranked as one of America's top 26 public research universities by the National Science Foundation. U.S. News has ranked UC in the Top Tier of America's Best Colleges. The Chronicle of Higher Education calls UC a "research heavyweight". Forbes, Delta Sky and Travel + Leisure magazines have named UC one of the most beautiful campuses.
Quality Assurance for Cell Therapy at Hoxworth Blood Center provides quality compliance oversight for blood and cellular product collection and processing in a FACT and AABB accredited facility. The Quality Assurance Specialist will be responsible for product release, batch record review and issuance. This position will assist with the development of new and revised Standard Operating Procedures (SOPs), establish new compliance programs, lead projects, perform audits, analyze data and report results, and ensure compliance with applicable regulations and standards.
The ideal candidate will have:
A working knowledge of some or all of the following standards or regulations; GMP, GTP, CAP, CLIA, AABB and FACT.
Previous experience in a quality role such as QC, QA or Compliance.
Experience in a clinical laboratory, blood bank, pharmaceutical, clean room or other regulated environment.
A working knowledge of Corrective Action/Preventive Action (CAPA), root cause analysis and effectiveness checks.
Previous experience reviewing batch production records, label approval and product release.
Minimum Qualifications: Bachelor degree with three (3) years of experience; -OR- Associate degree with five (5) years of experience; -OR- seven (7) years of experience. Degree and experience must be in a related field.
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).
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The University of Cincinnati is an Affirmative Action / Equal Opportunity Employer / Minority / Female / Disability / Veteran.