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Validation – IT Auditor II
CTI Clinical Trial and Consulting ServicesValidation & IT Auditor II reviewing computer system validation deliverables for regulated software and conducting audits for a clinical research organization.
About the role
Key responsibilities & impact- Review full computer system validation deliverables for regulated software, hardware, and laboratory instrumentation applications
- Conduct internal audits related to validated systems and IT processes
- Escalate unresolved observations to QA management
- Conduct vendor audits of SaaS vendors
- Prepare and distribute audit reports and assist with review of auditee response plans
- Assist QA leadership team with review of non-conformance root causes and implementation of effective corrective actions
- Maintain significant knowledge in global regulatory validation requirements
- Prepare training materials related to global validation requirements
Requirements
What you’ll need- Bachelor’s degree in business administration or physical/life science
- Documentation of exceptional performance in prior leadership role(s)
- At least 4 years in CRO, pharmaceutical, clinical or related fields
Benefits
Comp & perks- Generous health benefits
- Vacation packages
- Hybrid work from home opportunities
- Paid parental leave
- Ongoing education and training through tuition reimbursement
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
computer system validationinternal auditsvendor auditsaudit reportscorrective actionstraining materialsregulatory validation requirements
Soft Skills
leadershipcommunicationproblem-solving