QA Auditor II
Core
Conduct and lead client, internal, GCP, and regulatory audits to ensure compliance and quality standards in clinical environments.
Role type
Senior IC QA Auditor (Clinical/GCP)
Builds
Audit reports, findings, and compliance documentation for clients and internal operations.
Domain
Life Sciences / Clinical Research / Quality Assurance
Deliverable
client delivery
Required skills
GCP knowledge, regulatory guidelines proficiency, root cause analysis, risk assessment, impact analysis, audit leadership, database audit, clinical study report audit
Preferred skills
Vendor audit, process improvement, negotiation, conflict management, multi-tasking
Technologies
Computer software (in-house and off-the-shelf)
Responsibilities
Conduct and/or lead client, internal, GCP, and regulatory inspections; Perform directed site, facility, vendor, and sub-contractor audits; Provide GCP consultation to project teams and external clients; Prepare and present audit findings at meetings.
Seniority
Mid-level, hands-on IC
