Quality Assurance Auditor II- GCP

QA Auditor, Clinical Quality Assurance

Are you interested in working as an expert advisor on ICH and GCP guidelines and company SOPs throughout all phases of clinical studies while driving quality compliance procedures?

ICON is presently in over 40 countries with over 80 offices worldwide and has over 12K employees globally. ICON Clinical Research has a strong reputation in our approach to clinical development and provides innovative strategies to the drug development process including medical device products and development.

Plan and conduct regular and random QA audits (internal and external) in order to assure that clinical studies including medical device studies managed by ICON are of the highest standard and are in compliance. Comply with requirements of study protocols and relevant regulations.  Perform quality system audits, vendor/supplier audits and when required, .perform contract audits for Sponsor companies.  Ensure that audit results are formally recorded and reported and that corrective/preventative actions are documented.  When appointed lead auditor, perform the duties assigned in an efficient and effective manner.  This includes liaising with the project manager, including audit planning and review of audit results.  Assist in training new QA auditors.

We provide our Clinical Quality Assurance Auditors with an excellent benefits package that includes a comprehensive health plan, retirement plans, competitive pay, vacation, and an annual incentive plan to reward performance.  Additionally, we have cutting edge technology that will allow you to analyze study specific processes, audit reports, and governance to quality system checks and ensure compliance.

• A Bachelor’s degree
• GCP experience and understanding of medical device regulations for the conduct of clinical trials required. 
• Ability to review and evaluated clinical data/records
• Preferably, you have experience working on cross-functional teams including vendor and regulatory audits. 
• Experience auditing adaptive trial design studies preferred, but not required.
• Ability to successfully implement quality plans for specific phases of a trial.
• Ability to liaise successfully with project teams
• Good understanding of drug development and clinical trial process.
• Excellent communication and interpersonal skills.
• Coaching/mentoring skills
• Good planning and organizational skills.
• Willingness to travel up to 35% (domestic and/or international) when needed. 

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.

We invite you to review our opportunities at www.iconplc.com/careers.

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

We provide equal opportunity to all qualified applicants and employees by prohibiting discrimination in employment decisions because of race, color, religion, sex, national origin, age, veteran status or disability.