Quality Assurance Auditor II

Quality Assurance Auditor II - USA (Home-Based with Travel)

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We have an incredible opportunity for a Quality Assurance Auditor II to join ICON’s Full Service Quality & Compliance team. The QA Auditor II will conduct investigator site audits and supplier audits in the United States.

Location: USA (home-based) with up to 35% Domestic Travel

What you will be doing:

• Perform tasks relevant to the assigned Quality & Compliance (Q&C) function including but not limited to conducting internal and vendor audits and CAPA management
• Support with business development activities and Q&C initiatives as needed
• Escalate quality and compliance issues to Q&C Line Management and relevant ICON functions as appropriate
• Plan and conduct regular internal audits, study/project audits as well as contracted audits (including standalone work), for cause audits, vendor, and sub-contractor audits
• Report the results of the audit and any relevant findings and track them into the ICON systems
• Review audit responses by the auditees, follow up all outstanding replies, and escalate issues to the relevant management for action
• Assist the Q&C management with the development of the internal audit schedule
• Ensure ICON’s QMS tracking system is updated with the appropriate information and documentation
• Follow up on CAPA plans to ensure actions are completed on time and the evidences available are adequate
• Determine effectiveness check requirements for responsible CAPA, define the effectiveness check plan, track and complete the effectiveness checks as required, determine the outcome and inform operations and Q&C management accordingly
• Assist Q&C Management with oversight of open CAPAs, trending, and analysis of CAPAs and metrics reporting
• Ensure that any case types including Suspected Scientific Misconduct, Risk Cases, and Potential Serious Breach are tracked and documented as requested
   

Your profile:

• 2 years of experience conducting or assisting with site audits
• Clinical Research experience, either at a site, CRO, or sponsor
• Strong communication skills
• Detail oriented with organizational skills
• Ability to work both independently and as a team
• Bachelors Degree required
• Medical background or BSN preferred
• Ability to travel up to 35% with proximity to an airport

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What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements

• A range of health insurance offerings to suit you and your family’s needs.

• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.

• Life assurance

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment.  All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual ori