ICON Clinical Research

QA Auditor I

22 Feb 2021
24 Mar 2021
Quality, QA / QC
Full Time
Contract Type
Experience Level
Experienced (non-manager)
QA Auditor I

Location: Ireland

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.

The Role:
Our Quality Assurance Auditor will assess the compliance of ICON Laboratories to all federal/state of New York, US FDA GLP regulations, ICH E6(2) regulations, adherence to Guidance for Industry documents and ICON quality standards as well as assist with developing Standard Operating Procedures.
  • Plan and conduct regular and random internal QA audits in order to assure that all studies managed by ICON are of the highest standard and are in compliance with the requirements of ICON or Sponsor SOPs, study protocols, relevant regulations and guidelines. These will include in-process study inspections, data audits as well as table and report audits.
  • Ensure that audit results are formally recorded and reported and that corrective/preventive actions are documented.
  • When appointed lead auditor, perform the duties assigned in an efficient and effective manner. This includes liaison with the operations and/or operational lead on all QA issues, including audit planning and review of audit results.
  • Verification of audit CAPA completion where required by procedure.
  • Keep the person whom the QA Auditor reports to informed of any QA issues within the department that require attention.
  • Assist with preparation, conduct and follow up of Sponsor and Regulatory audits.
  • Review, assess, distribute and coordinate response for external audit reports to the appropriate departments - ensure CAPA follow-up is documented and reported to Management.
  • Participate in managing the recording, investigation, tracking and resolution of any Quality Issues.

What you need:
  • Bachelors' Degree in a related field (scientific background preferred)
  • 3 years of relevant experience.
  • Knowledge of US FDA GLP (21 CFR Part 58) and 21 CFR Part 11 regulations Experience in the area of regulated bioanalysis is preferred,
  • GCP/GMP auditing background may also be considered.
  • Attention to detail and high ethical standards is required.

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.

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