Quality Assurance Auditor II

ICON plc; Cambridge (MA); Hybrid; USD 70,000 - 120,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance

Retirement planning offerings

Employee Assistance Program LifeWorks

Life assurance

Flexible country-specific optional ben

Childcare vouchers

Bike purchase schemes

Discounted gym memberships

Job summary

ICON is a global healthcare intelligence and clinical research organisation uniting a mission to bring new medicines to patients faster. The role is QA Auditor II in Cambridge, MA, operating in a hybrid laboratory environment.

Onsite is required 3 days out of 5, with the support of a dynamic team focused on quality and compliance. You will partner with internal stakeholders to perform a variety of laboratory audits, vendor inspections, SOP reviews and CAPA management, while upholding ICH-GCP and

Qualifications

• Experience as a Quality Assurance/ Compliance Auditor.
• Experience within a Laboratory or Clinical environment is advantageous.
• Experience with ICH-GCP and with relevant GxP regulations and guidelines.
• BSc Degree is required.
• Strong communication and relationship management skills.

Responsibilities

• Perform internal and vendor audits, external audits/inspections, study audits, SOP and documentation review and CAPA management.
• Work within standardized procedures to meet quality standards and deadlines.
• Provide advice to operations on quality related issues.
• Escalate quality and compliance issues to Quality & Compliance Line Management and ICON functions as appropriate.
• Review SOPs for quality/compliance and contribute to procedures development and maintenance.
• Support case management processes including serious breaches or misconduct cases when required.

Skills

Quality Assurance

Auditing

Communication

Regulatory knowledge

GxP

Education

BSc Degree

Job description

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

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.

• 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.

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.

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.