Quality Assurance Auditor II at ICON plc in US, Cambridge, MA

Quality Assurance Auditor II

Location: US, Cambridge, MA · Office With Flex

QA Auditor II- Cambridge MA- hybrid

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

Job Title: QA Auditor – Laboratory/ GCP

Location: Cambridge MA- working within our Laboratory environment

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.

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

The role:

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 ( not limited to):

• 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.

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

#LI-FL1

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

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

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Salary Range

$68,616.00-$85,770.00

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