Senior Clinical QA Specialist
Core
Senior QA specialist ensuring compliance and quality across biometric services and computer systems through audits, risk management, and system validation.
Role type
Senior IC clinical QA specialist
Builds
Validated computer systems and compliant biometric services
Domain
Clinical research / Biometrics / Regulated software
Required skills
GxP, ICH-GCP, 21 CFR Part 11, SDLC principles, audit management, CAPA management, risk assessment, QMS maintenance, computer system validation, regulatory inspection readiness
Preferred skills
eClinical services experience, electronic QMS platforms (ZenQMS)
Technologies
Microsoft Office, ZenQMS
Responsibilities
Conduct internal and vendor audits; Review and audit Trial Master Files (TMF); Develop and maintain SOPs and QMS documents; Participate in computer system validation planning and execution; Lead audit and inspection readiness for regulatory bodies; Mentor junior QA team members; Analyze quality metrics and trends
Seniority
Senior, hands-on IC
