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

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

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

Experience performing and supporting compliance audits and investigating nonconformance events. Prior experience in clinical laboratory or pharmaceutical quality assurance environments is ideal, especially in settings that emphasize cross-functional collaboration, regulatory excellence, and continuous improvement mindset.

Physical Requirements/Work Environment

Office environment/no specific unusual physical or environmental demands.

Compensation and Benefits

UC offers an exceptional benefits package designed to support your well-being, financial security, and work-life balance. Highlights include:

Comprehensive Tuition Remission

UC provides tuition remission for you and your eligible dependents, covering tuition costs for nearly all undergraduate and graduate programs offered by the university.

Robust Retirement Plans

As a UC employee, you won’t contribute to Social Security (except Medicare). Instead, you’ll choose between state pension plans (OPERS, STRS) or an Alternative Retirement Plan (ARP), with UC contributing 14–18% of your salary based on position.

Real Work-Life Balance

UC prioritizes work-life balance with a generous time-off policy, including:

Vacation and sick time

11 paid holidays and additional end-of-year paid time off (Winter Season Days)

6 weeks of paid parental leave for new parents

Additional Benefits Include:

• Competitive salary based on experience
• Comprehensive health coverage (medical, dental, vision, prescription)
• Flexible spending accounts & wellness programs
• Professional development & mentorship opportunities