Quality Assurance Auditor I

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.

The Role: QA Auditor – Laboratory/ GCP

Location: Farmingdale, NY, working within our Laboratory environment

To be successful in the role, you will have:

Due the business function alignment of this role, there is a requirement for the individual to be onsite at the Laboratory 3 out of 5 days.

We are looking for a Quality Assurance Auditor to join our Global vibrant and passionate Laboratory Auditing Team.  You will partner with internal stakeholders, performing a variety of audit activities with our Laboratory environment.

Responsibilities will include:

•         Performing tasks relevant to our Lab environment such as conducting internal and vendor audits, external audits/inspections, study audits, SOP and documentation review and CAPA management.

•         Working within standardized procedures and practices to achieve objectives and meet quality standards and deadlines.

•         Providing advice to operations on quality related issues

•         Escalating quality and compliance issues to Quality & Compliance Line Management and relevant ICON functions as appropriate

•         Performing Quality & Compliance review of SOPs when designated this responsibility, and contribute to the development & maintenance of departmental and general procedures

•         If required, support case management processes including potential serious breaches, risk cases and suspected scientific misconduct cases.

           Travel 10 to 20% domestic or international

Experience and qualifications required:

·         Experience as a Quality Assurance/ Compliance Auditor

·         Experience within a Laboratory or Clinical environment in an advantage

·         Experience with, with ICH-GCP and with relevant GxP regulations and guidelines.

·         BSc Degree is required

·         Strong communication and relationship management skills

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 through the form below.