Quality Assurance Specialist

6 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 University of Cincinnati's Hoxworth Blood Center. As a QARC Specialist, you will play a critical role in ensuring the quality and compliance of our blood products and services.

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 to ensure compliance with regulatory requirements
  • Act as QA Representative to regulated departments, approving procedures and risk assessments, and supporting supplier qualification efforts
  • 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
Requirements
  • Associate's Degree or equivalent experience
  • Two years of relevant experience in quality assurance or regulatory compliance
  • 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

The University of Cincinnati offers a comprehensive benefits package, including competitive salary, comprehensive insurance plans, flexible spending accounts, and an award-winning employee wellness program. We also offer tuition remission, discounts for on and off-campus activities and services, and a generous paid time off work policy.



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