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Auburn University

Quality Assurance Specialist

Validation, Compliance & Quality SystemsUpdated on Nov 11
Full-timeAuburn, AL, USANo salary listedIn-person

About the Job

Requirements

  • Level II requires a bachelor's degree in Business, Management, Science, or a related field and four years of experience in quality management.
  • Level III requires a bachelor's degree in Business, Management, Science, or a related field and six years of experience in quality management.
  • Relevant experience may be substituted for the education requirement at a rate of two years of relevant experience per year of required education.

Responsibilities

  • Develop, implement, and maintain quality assurance policies, procedures, and standard operating procedures.
  • Maintain records, documentation, and reporting systems to support regulatory reviews, audits, and accreditation activities.
  • Monitor compliance with regulatory, accreditation, biosafety, animal care, and laboratory quality standards.
  • Manage electronic document control and Learning Management Systems, ensuring compliance with document versioning, approvals, periodic reviews, and employee acknowledgment requirements.
  • Conduct internal audits, inspections, and quality assessments to identify risks and opportunities for process improvement.
  • Keep up with regulatory and accreditation changes.
  • Coordinate quality improvement initiatives, such as proficiency testing or external quality assessment, and assist with implementing best practices across departments and laboratories.
  • Provide training and guidance to faculty, staff, students, and researchers on quality assurance requirements and procedures.
  • Review and analyze quality metrics, performance indicators, and compliance data to recommend corrective and preventive actions.
  • Investigate quality concerns, document findings, and support resolution of compliance issues.
  • Collaborate with internal and external stakeholders to ensure consistent application of quality standards and operational excellence.
  • Review and audit documentation.
  • Assist with developing and reviewing data capture forms.

Desired Qualifications

  • Experience overseeing Good Clinical Practice or Good Laboratory Practice standards.

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