QARC Specialist 2, Hoxworth Blood Center, Department of Quality Assurance, Hybrid

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Job Overview

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The College of Medicine, Hoxworth Blood Center is recruiting for a full-time (100 % FTE), Quality Assurance/Regulatory Compliance (QARC) Specialist 2 in the Department of Quality Assurance at Hoxworth Blood Center (HBC). This position will be responsible to ensure compliance of HBC to meet requirements of accrediting bodies and regulations and will support the University's mission and commitment to excellence and diversity in our students, faculty, staff, and all our activities.

 

The selected candidate will be responsible for complying with FDA regulations regarding component recall,  lookback, and consignee notification, review of testing results for donor reentry, and supporting Medical Services for required donor deferral notification.  This position will also support quality processes for the Blood Center 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. 

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 FDA regulations and guidance documents regarding positive donor test results and familiarity with FDA regulations regarding lookback.
• Experience performing and supporting compliance audits and investigating nonconformance events.
• Clinical Laboratory experience or degree is ideal.

Physical Requirements/Work Environment

• 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 medica