RTI Health Solutions · 20 hours ago
Quality Assurance Auditor
Raleigh, NC
Full-time
Onsite
Senior Level
5+ years expRTI Health Solutions is an independent research organization providing healthcare consulting and research expertise. The Quality Assurance Auditor will ensure compliance with internal standards and regulatory requirements, supporting both regulated and non-regulated research activities while fostering a culture of quality and integrity.
ConsultingHealth CareMarket ResearchMedical DevicePharmaceutical
Hiring Manager
Bob Miles
Responsibilities
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
Coordinate legal requests related to government investigations or litigation, as needed
Identify training needs and organize or deliver training to promote consistent, high-quality practices
Stay current on evolving regulations, guidance, and industry best practices
Help foster consistent quality standards globally while enabling best-practice sharing across teams
Qualification
Required
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
Strong organizational skills and the ability to prioritize multiple tasks effectively
Excellent verbal and written communication skills
A collaborative mindset and the ability to work well across teams and disciplines
Comfort working independently while contributing as part of a team
High attention to detail, accuracy, and follow-through
Preferred
Regulatory Affairs Certification or Quality Auditor Certification
Experience working in regulated research or healthcare consulting environments
Benefits
Competitive base salary
Generous paid time off policy
Merit based annual increases
Bonus opportunities
Robust recognition program
Competitive range of insurance plans (including health, dental, life, and short-term and long-term disability)
Access to a retirement savings program such as a 401(k) plan
Paid parental leave for all parents
Financial assistance with adoption expenses or infertility treatments
Financial reimbursement for education and developmental opportunities
Employee assistance program
Numerous other offerings to support a healthy work-life balance
Company
RTI Health Solutions
RTI Health Solutions' integrated project teams are here to help you with your pharmaceutical and medical device research needs.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Aisha Harvin
Quality Assurance Partner
Charles Roberts
Associate IT Business Partner
Recent News
Company data provided by crunchbase