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Quality Assurance Auditor

Location: Whitesboro, NY

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.

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.

Overview of 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.

Role Requirements

You will need to possess a Bachelors’ Degree in a related field (scientific background preferred), with 0-3 years of relevant experience. Knowledge of US FDA GLP (21 CFR Part 58) and 21 CFR Part 11 regulations with experience in the area of regulated bioanalysis is preferred, however individuals with a GCP/GMP auditing background may also be considered. Attention to detail and high ethical standards is required.

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.

What’s Next?

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

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Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader.
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QA Auditor I/ll

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