QA Auditor I

At ICON, it's our people that set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?

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.

The Role

• 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.

Why join us?

Ongoing development is vital to us, and as a QA Auditor you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success.

ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.

EOE race/color/religion/sex/sexual orientation/gender identity/disability/vet/national origin