Job Overview

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, c GMP, 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

Additional Qualifications Considered

• A working knowledge of standards or regulations: GMP, GTP, ISO14644, CLIA, AABB, FACT, ASHI.
• Experience reviewing batch production records, label approval and product release, is ideal.
• Expertise performing and supporting compliance audits and self-inspections.
• Experience with Quality Management software and intermediate to advanced skills with Excel, is ideal.
• Quality Assurance experience in a regulated environment (cell therapy, pharmaceutical, or biotech).
• Cleanroom experience is ideal.

Physical Requirements/Work Environment