Quality Assurance Auditor II - US, Salt Lake City, UT Hybrid: Office/Remote
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
Quality Assurance 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/Regulatory Authority inspections management, SOP and documentation review and CAPA management
.• Escalate quality and compliance issues to Q&C Line Management and relevant ICON functions as appropriate.
• Liaise with clients and operational staff on quality aspects which may include attendance at meetings, oral presentations and audits.
• Have a thorough knowledge of all relevant SOPs, with ICH-GCP and relevant regulations and guidelines.
• Build knowledge of the company, processes and customers.
.• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance
.• 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.
• Travel, (up to 20%) domestic and/or international, on occasion and this may increase based on business needs.
AUDITING Responsibilities:
• Plan and conduct regular internal audits of clinical research unit and/or early phase CRO service, contract audits of ICON quality system in order to evaluate the quality system against the requirements appropriate regulations and applicable guidelines.
• Perform vendor and sub-contractor audits and follow up of previous findings.
.• Review audit responses by the auditees. Follow up all outstanding replies and escalate issues to the relevant management for action.
• Ensure the audit results are formally recorded, reported, and that corrective/preventative actions are documented.
• Assist in the development of the project audit schedule.
• Verification of audit CAPA completion where required by procedure.
• *Lead the preparation, and host Sponsor audits & Regulatory Inspections of ICON
• *Lead investigations, root cause analysis (RCA) and resulting CAPA management for ICON Quality Issues
EXPERIENCE:
• Bachelor’s degree or relevant experience required
• 1 years experience within GCP Auditing an advantage
• 3 plus years experience working in a GCP environment
• Knowledge of GCP Guidelines and relevant regulations for the conduct of clinical trials
• Knowledge of CAPA management, including performing root cause analysis an advantage
• Experience in regulatory authority inspections an advantage
• Experience in regulatory authority inspections an advantage
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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:
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Various annual leave entitlements
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A range of health insurance offerings to suit you and your family’s needs.
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Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
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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.
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Life assurance
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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.
ICON, including subsidiaries, 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, colour, 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 or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
Top Skills
What We Do
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.
We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
