GLP Quality Assurance Auditor I

Quality Assurance Auditor I - Whitesboro, NY USA (Onsite Hybrid)

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We have an incredible opportunity for a Quality Assurance Auditor I to join ICON’s Full Service Bioanalytical Lab team in Whitesboro, New York. The Quality Assurance Auditor I will plan and conduct study audits, process audits, vendor audits, and sponsor audits for ICON’s bioanalytical lab in Whitesboro, NY.

Location: Whitesboro, NY USA (Hybrid Onsite - average of 3 days onsite per week)

Hours: Full-Time, Monday to Friday

What you will be doing:

• Perform tasks relevant to the assigned Quality & Compliance (Q&C) function which may include but not limited to conducting internal and vendor audits, External audits/inspections management, SOP and documentation review, and CAPA management
• Be familiar with all relevant SOPs, with ICH-GCP, and relevant regulations and guidelines
• Escalate quality and compliance issues to Q&C Line Management and relevant ICON functions as appropriate
• Recognize, exemplify, and adhere to ICON's values which center on Integrity, Accountability & Delivery, Collaboration, Partnership, and Own It @ ICON
• Embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
• Coordinate and lead internal audits including but not limited to conducting contracted, project, process, facility, self-inspection, and vendor audits
• Facilitate client audits and regulatory inspections of ICON and investigational sites (if applicable) and ensure that the client auditors and inspectors receive access to needed documentation and staff
• Effective CAPA Management according to ICON processes and Regulation 
• Support Operations with investigations, Root Cause Analysis (RCA), and resulting CAPA management of ICON audit findings
• Assist with the implementation and maintenance of an effective Quality Management System / Quality Assurance program
• Travel up to 35% (domestic and/or international) which may increase based on business needs

Your profile:

• Quality control and/or quality assurance experience with a focus on Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GLCP)
• 2+ years of industry experience
• Bioanalytical Lab experience (preferred)
• Strong attention to detail and organizational skills, with the ability to prioritize tasks effectively
• Excellent communication and interpersonal skills, with the ability to work collaboratively with cross-functional teams and stakeholders
• Bachelors degree in the field of healthcare or science or equivalent experience
• Ability to work onsite in Whitesboro, NY an average of 3 days per week

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What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Salary range: $56,704.00-$70,880.00

Bonus, Com, Stock, Benefits & Disclaimer verbiage:
Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance.

Are you a current ICON Employee? Please click here to apply