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Principal QA Auditor

US-Any US location-Home Based
Permanent
Reference: 057300_2
This vacancy has now expired.
Description

Principal Auditor, Clinical Quality Assurance (CQA) *L I-M

 

Position can be home based!


Position Summary:

  • Perform QA audits of clinical trial data and records in order to assure compliance with ICON or Sponsor SOPs, study protocols, Good Clinical Practice guidelines, relevant regulations and ISO  requirements.
  • Assist with the implementation and maintenance of an effective Quality Assurance program within ICON.
  • Assist with local project resourcing and the professional development of the QA Auditors.

Principal Auditor Role at ICON:

  • Effectively Plan and conduct QA audits in order to assure that clinical studies managed by ICON are of the highest standard and are in compliance with requirements of ICON/Sponsor Standard Operating Procedures, study protocols and relevant regulations.
  • Maintain a thorough knowledge of all relevant ICON SOPs, Good Clinical Practice guidelines, relevant regulations and ISO  requirements.
  • Perform quality system audits and process audits.
  • Perform supplier/vendor audits.
  • Perform contract audits for Sponsor companies.
  • Ensure that audit results are formally recorded and reported and that corrective/preventative actions are documented.
  • Assist with the review of audit reports and audit results, and with performing analyses and trending of audit results, as required.
  • Assist with the planning and coordination of specific projects related to the development and Improvement of the ICON Quality Assurance program
  • Perform lead auditor duties assigned in an efficient and effective manner. This includes liaising with the project manager on all QA issues, including audit planning and review of audit results.
  • Perform QA Review of SOPs, as required.
  • Train and mentor new QA auditors in order for them to perform their function effectively and provide a benchmark of auditing competencies to less experienced colleagues.

To succeed you will need:

  • Extensive experience in Quality Assurance GCP audits.
  • University/Bachelors Degree or local equivalent in medicine, science or equivalent degree/experience.
  • Thorough knowledge of GCP Guidelines and relevant regulations for the conduct of clinical trials.
  • Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams, investigators and clients.
  • Ability to successfully implement quality plans for all phases of a trial.
  • Travel Requirment up to 30%

Benefits of Working in ICON 

 

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  This varies from country to country so a dedicated recruiter will discuss this with you at interview stage. We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.   

 

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