Quality Assurance Auditor Ii

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.
Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Quality Assurance Auditor II Roles and Responsibilities:

• Perform tasks relevant to the assigned Quality & Compliance function which may include but not limited to conducting internal and vendor audits, external audits/inspections, study audits, SOP and documentation review and CAPA management, as applicable.
• Advanced Degree or equivalent experience preferred
• Assist with business development activities when appropriate.
• * Travel (up to 15%) domestic and/or international on occasion and this may increase as a result of business needs.
• * Escalate quality and compliance issues to Q&C Line Management and relevant ICON functions as appropriate.
• Perform Q&C review of SOPs when designated this responsibility, and contribute to the development & maintenance of departmental and general procedures
• * Recognize, exemplify and adhere to ICON's values which center on Integrity, Accountability & Delivery, Collaboration, Partnership and Own IT@ICON.
• If required, support case management processes including potential serious breaches, risk cases and suspected scientific misconduct cases.
• Provide advice to operations on quality related issues to any areas of the company under the guidance of his/her line manager.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• *Be familiar with all relevant SOPs, with ICH-GCP and with relevant GxP regulations and guidelines.
• * Work within standardized procedures and practices to achieve objectives and meet quality standards and deadlines.
• 3 to 5 years of CRO audit experience preferred
• Assist with performing business partnering with assigned operational department as requested.
• Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.
• Duties other than those outlined may be assigned'
• Perform structured work assignments in order to develop competency under supervision.
• Depending on Q&C function, an Auditor may be requested to complete all/some of the responsibilities listed below under each heading as needed.

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON is an equal opportunity and inclusive employer and 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 orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.