Quality Assurance Specialist

3 days ago


Cincinnati, Ohio, United States University of Cincinnati Full time
Job Overview

We are seeking a highly skilled Quality Assurance/Regulatory Compliance (QARC) Specialist 2 to join our team at the Hoxworth Blood Center, University of Cincinnati. This role will provide critical support to the QARC Department, ensuring compliance with accrediting bodies and regulations in the Cellular Therapy, Therapeutic Apheresis, and Transplantation Immunology divisions.

Key Responsibilities
  • Provide training and education to QA staff on compliance requirements.
  • Evaluate compliance of procedures, policies, and programs, and provide recommendations for improvement.
  • Perform routine QA and administrative duties, as well as non-routine program and project support.
  • Conduct internal and external audits, and act as QA Representative to regulated departments.
  • Administer and perform product recall report review, lookback evaluation, and consignee notifications.
  • Initiate deviations, IRIs, and CAPAs, and perform effectiveness checks.
  • Support Cellular Therapy Product, raw material, and Master Mix Release program.
  • Ensure compliance with specific product types and work with customer representatives on product nonconformances.
Requirements
  • Associate's Degree or equivalent experience.
  • Two years of relevant experience in quality assurance in a regulated environment.
  • Working knowledge of standards or regulations, such as GMP, GTP, ISO14644, CLIA, AABB, FACT, and ASHI.
  • Experience reviewing batch production records, label approval, and product release.
  • Expertise in performing and supporting compliance audits and self-inspections.
Benefits

As a UC employee, you will enjoy a comprehensive benefits package, including competitive salary, comprehensive insurance plans, flexible spending accounts, and an award-winning employee wellness program. You will also have access to tuition remission, discounts for on and off-campus activities, and a generous paid time off work policy.

The University of Cincinnati is an Equal Opportunity Employer. We are committed to diversity and inclusion, and we welcome applications from qualified candidates from diverse backgrounds.



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