Quality Assurance Auditor

The University of Miami/UHealth Department of Neurology is seeking a Full Time Quality Assurance Auditor to perform routine and focused audits of human subject research protocols to ensure compliance with federal, state, and local regulations, and research site standard operating procedures.

• Remain in compliance with federal, state, and local regulations, and extramural agencies' requirements.
• Conduct inquiries of laboratory and research protocols.
• Prepare reports of investigations and inquiries for internal or external use.
• Assist with the preparation of educational programs and present them to groups and individuals in the University’s research community.
• Monitor new legislation or changes in regulations that might affect the University’s compliance in conducting research and recommend changes to administrative policies and procedures.
• Assist in the creation and maintenance of internal policies and standard operating procedures, and University-wide policies intended to assist researchers in maintaining compliance with research standards and guidelines.
• Maintain quality assurance related databases, and electronic and paper audit files.
• Adhere to University and unit-level policies and procedures and safeguard University assets.

• Support regulatory compliance and quality assurance activities for the Brain Endowment Bank in alignment with NIH contract requirements.
• Partner with the Executive Director, operational committee, and key stakeholders to ensure compliant biospecimen management.
• Review and update the Quality Management Plan (QMP) and Standard Operating Procedures (SOPs) to support continuous improvement and compliance with NCI best practices and applicable regulations.
• Conduct quarterly internal audits and serve as the external auditor for the biennial audit process.
• Oversee ongoing quality assurance activities, including review of procedures, outcomes, and investigations of nonconforming brain/tissue products and processes.
• Report quarterly and biennial audit results and routine evaluations of QMP and SOP effectiveness to the Contracting Officer’s Representative (COR).

• Bachelor’s degree in a relevant field.
• Minimum 1 year of relevant experience.
• Knowledge, skills, and abilities: learning agility, teamwork, technical proficiency, and strong written and verbal communication skills.
• Any relevant education, certifications, and/or work experience may be considered.

The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.