Quality Assurance Auditor
Core
Conducts routine and focused audits of human subject research protocols and biospecimen management to ensure compliance with federal, state, local regulations, and NIH/NCI contract requirements.
Role type
Quality Assurance Auditor (Regulatory Compliance)
Builds
Quality Management Plans (QMP), Standard Operating Procedures (SOPs), audit reports, and internal policies for research compliance.
Domain
Healthcare research / Biospecimen management / Regulatory compliance
Deliverable
dashboards & analysis
Required skills
Regulatory compliance knowledge, audit execution, report writing, policy development, database management, stakeholder collaboration
Preferred skills
Learning agility, technical proficiency with office software, clear communication
Technologies
Office software, electronic audit files, quality assurance databases
Responsibilities
Conduct quarterly internal audits and serve as external auditor for biennial audits; Review and update QMP and SOPs; Monitor new legislation and recommend policy changes; Prepare reports of investigations for internal or external use; Maintain quality assurance databases and audit files.
Seniority
Entry-level, hands-on IC