Quality Assurance/Regulatory Compliance (QARC) Specialist 2, Hoxworth Blood Center

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 47,000 students, 10,500 faculty and staff and 330,000 alumni, UC combines a Top 35 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, eight straight years of record enrollment, worldwide leadership in cooperative education, a dynamic academic health center and entry into the Big 12 athletic conference, UC’s momentum has never been stronger. UC’s annual budget tops $1.6 billion and its endowment totals $1.9 billion.

The College of Medicine, Hoxworth Blood Center is recruiting a full-time Quality Assurance/Regulatory Compliance Specialist 2 (QARC 2) to provide support to the Quality Assurance/Regulatory Compliance (QARC) Department and to the 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 and diversity in our students, faculty, staff, and all our activities.

• 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.

• Associate's Degree
• Four (4) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.

Two (2) years of relevant experience.

• Office environment/no specific unusual physical or environmental demands.

Compensation and Benefits

UC offers a wide array of complementary and affordable benefit options, to meet the financial, educational, health, and wellness needs of you and your family. 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.

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).

The University of Cincinnati is an Affirmative Action / Equal Opportunity Employer / Minority / Female / Disability / Veteran.

REQ: 88625 

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