Experienced Quality Auditor II - Remote Opportunity for a Seasoned Professional in the US to Drive Excellence in Clinical Research and Quality Assurance

Introduction to Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is a world-renowned company dedicated to enabling our customers to make the world healthier, cleaner, and safer. With a team of over 100,000 colleagues globally, we share a common set of values - Integrity, Intensity, Innovation, and Involvement. Our mission is to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. We are now seeking an experienced Quality Auditor II to join our team, working fully remotely from the US, to contribute to our goal of delivering high-quality services and ensuring compliance with regulatory requirements.

Job Overview

In this critical role, you will conduct and lead various client-requested GCP audits, site inspection readiness visits, and regulatory inspections support visits. You will provide GCP consultation and support to project teams and external clients, perform other types of QA audits or activities, and lead QA-related projects. Your expertise will be invaluable in preparing and presenting audit findings and other related information at internal or client meetings. As a knowledgeable resource to operational departments, you will serve as a subject matter expert on audits and quality assurance.

Key Responsibilities

• Conduct and/or lead a variety of client-requested GCP audits, including clinical sites globally, site inspection readiness visits, and regulatory inspections support visits.
• Provide GCP consultation and support to project teams and external clients, ensuring they are equipped to meet regulatory requirements and quality standards.
• Perform other types of QA audits or activities, such as documentation review, database audits, clinical study report audits, and SOP development support.
• Lead QA-related projects, preparing and presenting audit findings and other related information at internal or client meetings.
• Serve as a knowledgeable resource to operational departments on audits and quality assurance subject matter, providing guidance and support as needed.
• Lead SSM investigations and support Quality Events and Planned Deviations (GPHS), ensuring that all issues are thoroughly investigated and resolved.

Essential Functions and Other Job Information

In this role, you will be responsible for conducting and/or leading various audits and regulatory inspections, providing consultation and support to project teams and external clients, and leading QA-related projects. You will also serve as a subject matter expert on audits and quality assurance, providing guidance and support to operational departments.

Qualifications

To be successful in this role, you will need:

• A Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
• Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
• Thorough knowledge of GxP and appropriate regional research regulations and guidelines.
• Demonstrated proficiency in leading a range of project-based or internal GxP audits and vendor audits to high standards required by management.
• Excellent oral and written communication skills, with the ability to effectively communicate complex information to various stakeholders.
• Strong problem-solving, risk assessment, and impact analysis abilities, with a solid experience in root cause analysis.
• Above-average negotiation and conflict management skills, with the ability to effectively manage competing demands and prioritize workload.
• A valid driver's license and the ability to qualify for and maintain a corporate credit card with a sufficient credit line for business travel.

Travel Requirements

This role will involve 50-75% travel, both domestic and international. If you are not willing to travel this much, unfortunately, you will not qualify for this role. We are looking for a candidate who is flexible and able to adapt to changing travel requirements.

Our 4i Values

At Thermo Fisher Scientific, we are guided by our 4i values - Integrity, Innovation, Intensity, and Involvement. We believe that these values are essential in driving our mission and vision, and we look for candidates who share these values and are passionate about making a difference.

Career Growth Opportunities and Learning Benefits

As a Quality Auditor II at Thermo Fisher Scientific, you will have access to a range of career growth opportunities and learning benefits. You will be part of a global team of professionals who are passionate about delivering high-quality services and ensuring compliance with regulatory requirements. You will have the opportunity to develop your skills and expertise, working on complex projects and collaborating with cross-functional teams. We offer a range of training and development programs, including on-the-job training, mentorship, and formal education opportunities.

Work Environment and Company Culture

At Thermo Fisher Scientific, we are committed to creating a work environment that is inclusive, diverse, and supportive. We believe that our employees are our greatest asset, and we strive to create a culture that is collaborative, innovative, and rewarding. We offer a range of benefits, including flexible working arrangements, employee recognition programs, and a comprehensive rewards package.

Compensation, Perks, and Benefits

We offer a competitive salary and a range of benefits, including health insurance, retirement savings, and paid time off. We also offer a range of perks, including flexible working arrangements, employee recognition programs, and a comprehensive rewards package. We believe that our employees are our greatest asset, and we strive to create a culture that is collaborative, innovative, and rewarding.

Conclusion

If you are a motivated and experienced quality assurance professional looking for a new challenge, we encourage you to apply for this exciting opportunity. As a Quality Auditor II at Thermo Fisher Scientific, you will have the opportunity to work on complex projects, collaborate with cross-functional teams, and contribute to our mission of delivering high-quality services and ensuring compliance with regulatory requirements. Don't miss out on this opportunity to join our team and make a difference in the lives of patients around the world. Apply now and take the first step towards a rewarding and challenging career with Thermo Fisher Scientific.

Ready to Apply?

If you are a motivated individual ready to contribute to a thriving team, we encourage you to apply now! We are excited to review your application and discuss this opportunity further. Please submit your application, including your resume and a cover letter, and we will be in touch soon.