Quality Assurance Specialist II

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Performs review, coding, and entry of audit report findings, assists with facilitation of Corrective and Preventative Actions (CAPAs), and participates in GCP related projects.  Participates in facilitating or co-audits as experience increases and proficiency is demonstrated.

Researches regulations and guidance documents governing GCP and conveys information to auditors
-Researches the published information, interacts with other QA/regulatory professionals and maintains knowledge of current expectations 
-Compiles question responses from QA staff and literature and shares throughout PRA as needed 
Participates in CAPA facilitation, including support and training of operational representatives and, with guidance of auditors, providing QA input into content
Participates, with supervision, on GCP related projects initiated by internal stakeholders
Maintains, and/or updates tracking tools maintained by the QA department.

• An undergraduate degree or its international equivalent from an accredited institution required.
• Experience in clinical research organization is preferred, however, must possess a technical knowledge that is applicable to clinical drug development and possess the expected ability to master the needed understanding of clinical and technical areas not already known.
• Basic understanding of ICH GCP, FDA CFR, and EU directive
• Read, write and speak fluent English; fluent in host country language required.
• Preferably in the health-sciences 

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, 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.