Quality Assurance Specialist 2

9 hours ago

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

The University of Cincinnati is seeking a Quality Assurance and Regulatory Compliance Specialist 2 to join the Hoxworth Blood Center team. This role will provide support to the Quality Assurance and Regulatory Compliance Department, ensuring compliance with accrediting bodies and regulations. The ideal candidate will have a strong background in quality assurance and regulatory compliance, with experience in a regulated environment such as cell therapy, pharmaceutical, or biotech.

Essential Functions
  • Provide training to QA staff and education in compliance requirements.
  • Skilled in tasks required to support QARC in assigned area of responsibility.
  • Evaluate compliance of procedures, policies, and programs. Provides recommendations for improvement.
  • Perform routine assigned QA and administrative duties and occasional non-routine program, project support and resolution of issues.
  • Perform internal and/or external audits.
  • Act as QA Representative to regulated department. Approve procedures and risk assessments. Support Supplier Qualification efforts. Review and approve validation documentation.
  • Act as system administrator for Quality Management System (QMS).
  • Review and approve calibration and maintenance records.
  • Prepare Quality Metric trend reports.
  • Administer or perform product recall report review, lookback evaluation, and consignee notifications.
  • Initiate deviations, IRIs, and CAPAs. Perform effectiveness checks.
  • Support Cellular Therapy (CT) Product, raw material, and Master Mix Release program.
  • Ensure all requirement for specific product types are appropriately met. Work with customer representatives on product nonconformances as indicated. Act as delegated authority for final disposition of IND and specific commercial products.
  • Attend, contribute to, and lead meetings as requested.
  • Follow procedures and policies. Evaluate compliance of own and others work. Supports Hoxworth Blood Center's safety, cGMP, and Quality Plan.
  • Perform related duties based on departmental need. This job description may be changed at any time.
Required Education
  • Associate's Degree.
  • Four (4) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.
Required Experience

Two (2) years of relevant experience.

Additional Qualifications Considered
  • A working knowledge of standards or regulations: GMP, GTP, ISO14644, CLIA, AABB, FACT, ASHI.
  • Experience reviewing batch production records, label approval and product release, is ideal.
  • Expertise performing and supporting compliance audits and self-inspections.
  • Experience with Quality Management software and intermediate to advanced skills with Excel, is ideal.
  • Quality Assurance experience in a regulated environment (cell therapy, pharmaceutical, or biotech).
  • Cleanroom experience is ideal.
Physical Requirements/Work Environment
  • Office environment/no specific unusual physical or environmental demands.

Compensation and Benefits

The University of Cincinnati offers a competitive salary range, comprehensive insurance plans, flexible spending accounts, and an award-winning employee wellness program. Eligibility varies by position and FTE.

  • Competitive salary range dependent on the candidate's experience.
  • Comprehensive insurance plans including medical, dental, vision, and prescription coverage.
  • Flexible spending accounts and an award-winning employee wellness program, plus an employee assistance program.
  • Financial security via our life and long-term disability insurance, accident and illness insurance, and retirement savings plans.
  • Generous paid time off work options including vacation, sick leave, annual holidays, and winter season days in addition to paid parental leave.
  • Tuition remission is available for employees and their eligible dependents.
  • Enjoy discounts for on and off-campus activities and services.

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