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



ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I - IV clinical studies



ICON Clinical Research, a division of ICON plc, specializes in the planning, management and analysis of Phase II - IV clinical trials.



ICON enjoys a strong reputation for quality and is focused on staff development. We continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.

Position Summary:



ICON Clinical Research has an immediate opportunity for a Quality Assurance Specialist I or II (title to be determined commensurate with experience). The successful candidate will provide quality assurance support to the Interactive Technologies division of ICON.



The individual will perform QA audits in order to assure compliance with ICON SOPs, sponsor requirements, study protocols, relevant regulatory requirements including Good Clinical Practice guidelines, and ISO 9000 requirements, related to ICON Interactive Technologies projects. Some of the responsibilities will include:



* Will plan and conduct both internal and external QA audits in order to assure that Interactive Technology

processes and projects are of the highest standard and are in compliance with the requirements of ICON or

Sponsor SOPs, study protocols, relevant regulations and guidelines and with ISO 9000 requirements.

* Conduct quality systems audits if required.

* Perform contract audits for Sponsor companies as required.

* 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 project manager on all QA issues, including audit planning and review of audit results.

* Will assist with the development of the audit procedures.

* Assist in training new QA Auditors and ICON staff regarding GCP, ISO 9000, role of QA, regulatory inspections,

etc.

* Conduct induction/orientation of new staff in ICON quality policies and procedures.

* Provide QA support and coordination for external audits.

* Will assist Interactive Technologies personnel in analyzing and improving processes from a Regulatory, Software

Validation, and QA viewpoint.



Position Qualifications and Required Experience:



* Must have 1.5 years of computer validation or information sciences experience in a FDA-regulated environment.

* Should have experience in complying with relevant regulations, especially 21 CFR Part 11.

* Must possess a good understanding of drug development and clinical trial process.

* Excellent communication and interpersonal skills with the ability to liaise successfully with project teams.

* Willing to travel at least 10% of the time.

Come to ICON and be an important part of a well respected and growing company that believes the details of your career are every bit as critical as the work you do. You'll enjoy highly competitive compensation and an exceptional benefits package that includes: Medical, Dental, and Vision Insurance, Flexible Spending Accounts, Short Term and Long Term Disability, Life and AD&D Insurance, 401K Plan with matching contributions, a generous program of Vacation, Holidays and Personal Time Off and more.



ICON. A Symbol of Excellence



ICON Clinical Research is an Equal Opportunity Employer committed to strength in diversity.



Central Laboratories/Clinical Research/Contracting Solutions/Development Solutions/Medical Imaging



www.iconplc.com