Quality Assurance Auditor
RTI International
full-time
Posted on:
Location Type: Remote
Location: North Carolina • United States
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Tech Stack
About the role
- Provide expert guidance on policies, regulations, and agency guidelines to ensure compliance across projects and functions
- Partner closely with operating teams to assess processes, identify risks, and support continuous quality improvement
- Lead and support audit and inspection readiness, including preparation, execution, and resolution of findings
- Serve as a liaison with internal and external auditors, inspectors, and oversight bodies throughout the audit lifecycle
- Conduct internal audits and inspections (including GCP and non-regulated documentation)
- Track, manage, and close corrective and preventive actions (CAPAs)
- Review and support project documentation and validated systems
- Develop, review, and maintain standard operating procedures (SOPs), QA policies, and related documentation
- Write audit plans and reports and support proposal review activities
- Identify training needs and organize or deliver training to promote consistent, high-quality practices
Requirements
- Bachelor’s degree plus 5+ years of related experience
- Experience supporting or conducting GCP audits and inspections
- Strong proficiency with Microsoft Word, Excel, PowerPoint, and Outlook
- Preferred Regulatory Affairs Certification or Quality Auditor Certification
- Experience working in regulated research or healthcare consulting environments
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
- Merit based annual increases
- Bonus opportunities
- Education and developmental opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GCP auditsinternal auditsinspection readinesscorrective and preventive actionsstandard operating proceduresquality assurance policiesaudit plansproject documentationvalidated systems
Soft Skills
expert guidancerisk assessmentcontinuous quality improvementliaisontraining organizationcommunication
Certifications
Regulatory Affairs CertificationQuality Auditor Certification