Quality Assurance Auditor II

Quality Assurance Auditor II, United States-Homebased

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

QA Auditor II- Can be remote- Central or Eastern Time Zones

Recognize, exemplify and adhere to ICON's values which centre on Integrity, Accountability & Delivery, Collaboration, Partnership and Own IT@ICON

• Perform tasks relevant to the assigned Quality & Compliance function which may include but not limited to conducting contracted/billable internal and vendor audits, documentation review and CAPA management.
•Conduct departmental and ICON staff training regarding ICON's quality system, Q&C tasks & processes, applicable standards, regulations; mentor new or developing Q&C staff as assigned, including providing constructive and effective feedback to trainees regarding skill capabilities during training.
• 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 (related to billable audits) which may include attendance at meetings, oral presentations and audits.
• Assist with business development activities, including the preparation of contracted audit cost proposals/contracts, and attend marketing presentation, when appropriate.
• Have a thorough knowledge of all relevant SOPs, with ICH-GCP and relevant regulations and guidelines.
• Understand key business drivers; uses this understanding to accomplish own work.
• Assume additional responsibilities, which are directed by the Q&C Manager or higher.
• Recognize, exemplify and adhere to ICON's values which centre around our commitment to People, Clients and Performance.
• If required, support case management processes including potential serious breaches, risk cases and suspected scientific misconduct cases.
• 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 35%) domestic and/or international, on occasion and this may increase based on business needs.
• Other duties as assigned. Depending on Q&C function, an Auditor may be requested to complete all/some of the responsibilities listed below under each heading as needed.

 Auditing Responsibilities:

• Plan and conduct regular billable/contracted internal audits, study/project 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 as requested.
• 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 billable audit schedule.
• Train QA auditors, and provide a standard for auditing to inexperienced or less experienced colleagues.
• Operates under moderate supervision and direction and makes decisions frequently that have a direct impact upon the local external and internal audit schedule and the resource allocation for audits within the local department.
• Ensure  that the ICON’s  QMS/  tracking  system  is updated  with  the  appropriate  information  and documentation.   
• Follow-up of 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 with the review of effectiveness check plans and effectiveness check outcomes for more junior QA auditors. 
• Assist Q&C Management / Director with oversight of open CAPAs (billable audits), trending and analysis of CAPAs and metrics reporting.

What you need: 

Minimum of 2 years of Site Audit experience.

Must have Clinical Audit experience.

Medical background (Nursing) or BS degree is preferred. 

#LI-Remote

#LI-MO1

What ICON can offer you:

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 orientation, gender identity, national origin, disability or protected veteran status.

Are you a current ICON Employee? Please click here to apply