QA Compliance Auditor, Central Lab Services
Core
Conduct internal, vendor, and sponsor audits; support regulatory and accreditation inspections (NMPA, CAP, ISO 15189); ensure regulatory compliance and quality assurance responsibilities are followed.
Role type
QA Compliance Auditor
Builds
Audit reports, corrective action plans, updated SOPs, and quality metrics
Domain
Healthcare diagnostics / Laboratory services
Deliverable
client delivery
Required skills
Regulatory compliance auditing, GCP/GLP knowledge, internal audit execution, vendor audit execution, inspection support coordination, SOP drafting, quality metrics reporting, corrective action implementation
Preferred skills
NMPA inspection support, client audit hosting, vendor audit hosting, CAP and ISO 15189 familiarity
Technologies
N/A
Responsibilities
Support regulatory inspections (e.g., NMPA), support lab accreditation inspections (CAP, ISO 15189), support sponsor audits, conduct internal audits per global audit plan, conduct vendor and supplier audits per global audit plan, contribute to global QA policies and SOP review and drafting, provide subject matter expertise on regulation interpretation, deliver training to new QA members, participate in global Quality initiatives, support reporting of quality metrics and implementation of corrective actions
Seniority
Mid-level, hands-on IC