Quality Assurance Auditor

University of Miami•Miami, FL

1d•Onsite

About The Position

The University of Miami/UHealth department of Neurology has an exciting opportunity for a Full Time Quality Assurance Auditor to work at the UHealth Medical Campus. The Quality Assurance Auditor conducts routine and focused audits of human subject research protocols to ensure compliance with federal and local regulations and guidelines, and research site specific standard operating procedures. The incumbent advises appropriate institutional officials of deficiencies and recommends necessary corrective actions, with follow up to ensure that needed actions have been implemented. Department Specific Functions Responsible for supporting regulatory compliance and quality assurance activities for the Brain Endowment Bank in alignment with NIH contract requirements. This role partners with the Executive Director, operational committee, and key stakeholders to ensure compliant biospecimen management and adherence to applicable regulations. Collaborate with the Brain Bank Executive Director and Operational Committee to ensure compliance with all regulatory and contractual requirements, including oversight of compliant biospecimen management practices. Partner with the Brain Endowment Bank Executive Director and Research Laboratory Manager to review and update the Quality Management Plan (QMP) and Standard Operating Procedures (SOPs) to support continuous improvement and ensure compliance with NCI best practices and applicable local, state, and federal 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. Collaborate with the Executive Director to report quarterly and biennial audit results and routine evaluations of QMP and SOP effectiveness to the Contracting Officer’s Representative (COR). This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.

Requirements

Bachelor’s degree in relevant field required
Minimum 1 year of relevant experience required
Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
Teamwork: Ability to work collaboratively with others and contribute to a team environment.
Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.
Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders.
Any relevant education, certifications and/or work experience may be considered.

Responsibilities

Remains in compliance with federal, state, and local regulations, and extramural agencies' requirements, and conducts inquiries of laboratory and research protocols.
Prepares reports of investigations and inquiries for internal or external use.
Assists with the preparation of educational programs and presents them to groups and individuals in the University’s research community.
Monitors new legislation or changes in regulations that might affect the University's compliance in conducting research and recommends changes to administrative policies and procedures.
Assists in the creation and maintenance of internal policies and standard operating procedures, as well as University-wide policies intended to assist University researchers in maintaining compliance with research standards and guidelines.
Maintains quality assurance related databases, and electronic and paper audit files.
Adheres to University and unit-level policies and procedures and safeguards University assets.
Responsible for supporting regulatory compliance and quality assurance activities for the Brain Endowment Bank in alignment with NIH contract requirements.
Partners with the Executive Director, operational committee, and key stakeholders to ensure compliant biospecimen management and adherence to applicable regulations.
Collaborate with the Brain Bank Executive Director and Operational Committee to ensure compliance with all regulatory and contractual requirements, including oversight of compliant biospecimen management practices.
Partner with the Brain Endowment Bank Executive Director and Research Laboratory Manager to review and update the Quality Management Plan (QMP) and Standard Operating Procedures (SOPs) to support continuous improvement and ensure compliance with NCI best practices and applicable local, state, and federal 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.
Collaborate with the Executive Director to report quarterly and biennial audit results and routine evaluations of QMP and SOP effectiveness to the Contracting Officer’s Representative (COR).