Quality Assurance (QA) Auditor
Core
Support and audit global clinical trials across pharmaceuticals, biologics, and medical devices to maintain regulatory standards.
Role type
Senior IC Quality Assurance Auditor
Builds
Audit management plans, audit strategies, and compliance reports for ongoing clinical trials
Domain
Clinical Research / Life Sciences / Regulatory Compliance
Deliverable
client delivery
Required skills
Good Clinical Practice (GCP) knowledge, audit planning, vendor/investigative site auditing, regulatory authority interaction, SOP development, software validation assessment, training material creation
Preferred skills
Medical Device experience, Phase 1 clinical trial experience
Technologies
Cloud-based software, proprietary software
Responsibilities
Develop audit management plans and strategies; Coordinate internal system audits and external investigative site/vendor audits; Participate in developing departmental SOPs and work instructions; Assess security of proprietary and cloud-based software; Develop training materials and proficiency tests
Seniority
Mid-level, hands-on IC