Quality Assurance Auditor II-GCP

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.

In this role of QA Auditor II you will be responsible for:

• Perform tasks relevant to the assigned Quality & Compliance (Q&C) function including but not limited to conducting internal and vendor audits, External audits/Regulatory Authority Inspections management and CAPA management. 
• Assist with the implementation and maintenance of an effective Quality Management System / Quality Assurance program within the relevant Quality &Compliance team.
• Perform departmental and ICON staff training regarding ICON's quality system, Q&C tasks & processes, applicable standards, regulations
• Escalate quality and compliance issues to Q&C Line Management and relevant ICON functions as appropriate.
• Travel (up to 10%) 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 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 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 audit schedule.
• 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.

External Audits/Inspection Management responsibilities: 

• Lead the preparation, and host Sponsor audits & Regulatory Inspections of ICON and of Investigational Sites. This may include but it’s not limited to:
• Supporting  ICON and Sponsor operational teams during the audit/inspection
• Liaising with the sponsor as needed
• Reviewing & processing any ICON document requests
• Finalizing and distributing daily summaries
• Attending the audits/inspection on site as needed
• Follow-up activities including provision of outstanding requests
• Lead inspection readiness team activities for projects/programs/assets.
• Support/mentor other Auditors with the tools needed to host independently.

CAPA Management Responsibilities:  

• Lead investigations, root cause analysis (RCA) and resulting CAPA management for ICON Quality Issues.
• External audits/inspections findings ensuring responses/CAPA are in line with ICON SOPs and submitted within the require timelines.
• 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.
• Perform the assessment of the potential Quality Issues to determine whether they meet the requirements of an ICON Quality Issue , document the outcome and record the Quality Issues as requested.
• 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, trending and analysis of CAPAs and metrics reporting. This includes providing summary information/input to Governance reports.
• Support ICON functions and client for regulatory  reporting such as regulatory reporting documentation as needed.
• Ensure that any case types including suspected scientific misconduct, risk cases and potential serious breach  is tracked and documented as requested.
• Liaise with clients and regulatory authorities as needed

Experience:

• Minimum of  3 years’ experience in clinical research and/or monitoring
• 1-2 years GCP auditing experience (preferred)

#LI-MO1

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.