QARC Specialist 2, Hoxworth Blood Center, Division of Quality Assurance

Current UC employees must apply internally via SuccessFactors 

Founded in 1819, the University of Cincinnati ranks among the nation’s best urban public research universities. Home to 53,235 students, nearly 12,000 faculty and staff and 350,000+ living alumni, UC combines a Top 35 public research university with a physical setting The New York Times has called “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, the oldest and one of the largest cooperative education programs, a dynamic academic health center and entry into the Big 12 Conference, UC’s momentum has never been stronger. UC’s annual budget stands at $1.85 billion, and its endowment totals $2 billion.

 

UC is a mission-driven organization where we are committed to student success and positively transforming the community through scholarship and service.  We thrive on innovation, making an impact, and fostering an environment where staff and faculty are key contributors to UC’s success.   

Job Overview

$5,000 SIGN ON BONUS IS AVAILABLE!

The University of Cincinnati, Hoxworth Blood Center (HBC) is actively recruiting for a full-time (100 % FTE), Quality Assurance/Regulatory Compliance (QARC) Specialist, Level 2, in the Division of Quality Assurance. This role is a vital part of our team, ensuring the integrity, safety, and compliance for HBC operations with all applicable regulatory and accrediting body requirements. 

 

The selected candidate will be responsible for supporting the Blood Center's quality processes as required by regulations and standards, such as audits, deviation management, change management, supplier qualification and document control. This is primarily a first shift position with a potential for a hybrid remote schedule after training is complete. 

 

This position offers opportunities for career advancement, mentorship, and continued education. 

 

Saving lives is no easy task, but at Hoxworth Blood Center, it's what we do every day and we're looking for positive, collaborative, and professional individuals motivated by the opportunity to support a mission that saves lives every day. If you are a detail-oriented individual with experience in quality and regulatory compliance, and a passion for making a difference in the lives of others, then we invite you to apply for this 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 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

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