Job Information
University of Cincinnati QARC Specialist 2, Hoxworth Blood Center, Department of Quality Assurance in Cincinnati, Ohio
QARC Specialist 2, Hoxworth Blood Center, Department of Quality Assurance Current UC employees must apply internally via SuccessFactors > http://bit.ly/UCEMPL Founded in 1819, the University of Cincinnati ranks among the nation's best urban public research universities. Home to more than 50,000 students, 11,000 faculty and staff and 340,000 alumni, UC combines a Top 35 public research university with a physical setting The New York Times calls "the most ambitious campus design program in the country." With the launch of Next Lives Here, the Cincinnati Innovation District, a $100 million JobsOhio investment, nine straight years of record enrollment, worldwide leadership in cooperative education, a dynamic academic health center and entry into the Big 12 Conference, UC's momentum has never been stronger. UC's annual budget tops $1.65 billion and its endowment totals $1.8 billion. The University's overall regional economic impact exceeds $10.6 billion, paving the way for the future of Cincinnati. Job Overview SIGN ON BONUS IS AVAILABLE! Hoxworth Blood Center (HBC), University of Cincinnati, was founded in 1938 and serves more than 30 hospitals in 18 counties in Southwestern Ohio, Northern Kentucky, and Southeastern Indiana. Annually, Hoxworth collects more than 100,000 units of blood from local donors to help save the lives of patients in area hospitals. Hoxworth Blood Center: Saving Lives Close to Home. HBC is located within the College of Medicine and is the only Regional Blood Center owned and operated by a University in United States. The University of Cincinnati, College of Medicine, Hoxworth Blood Center, is recruiting for a Quality Assurance/Regulatory Compliance (QARC) Specialist 2 position, to provide support to the Quality Assurance/Regulatory Compliance (QARC) Department and Hoxworth Blood Center (HBC). Ensure compliance of HBC to meet requirements of accrediting bodies and regulations. This position will support the University's mission and commitment to excellence in our students, faculty, staff, and all our activities. Saving lives is no easy task, but at Hoxworth Blood Center, it's what we do every day and we're looking for positive, professional individuals to join our team and help advance our lifesaving mission. If you are a detail-oriented individual with quality and regulatory compliance experience, and a passion for making a difference in the lives of others, then we invite you to apply for a position at Hoxworth Blood Center. 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 polic