GCP QA Auditor III

ThermoFisher Scientific; Austin (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Quality Assurance Auditor III to lead complex audits and ensure compliance with GCP guidelines and client requirements. The role involves multi-department coordination, regulatory inspections, and providing strategic audit insights to drive quality improvements.

You will mentor junior auditors, review technical documents, and present findings to management and clients. Strong communication, risk assessment, and root cause analysis skills are essential.

Qualifications

• Bachelor's degree or equivalent and relevant formal academic qualification.
• 5+ years’ GCP QA experience or equivalent in audits and regulatory environments.
• Equivalency accepting combination of education, training, and related experience.

Responsibilities

• Conduct and/or lead client, internal or GCP audits and regulatory inspections.
• Lead site audits, facility, vendor and subcontractor audits.
• Provide GCP consultation and support to project teams and external clients.
• Lead process audits and participate as co-auditor in complex system audits.
• Prepare and present audit findings to management and clients.
• Mentor junior auditors.

Skills

GCP audits

Audit leadership

Regulatory knowledge

Communication

Root cause analysis

Risk assessment

Negotiation

Multi-tasking

Travel readiness

Education

Bachelor's degree or equivalent

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Quality Assurance Auditor III - Make an Impact at the Forefront of Innovation

The Quality Assurance Auditor III leads complex and/or multi-department internal and/or external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. This role identifies issues impacting quality and regulatory compliance, determines the root cause of non-conformance, and develops strategies to address these issues. The Quality Assurance Auditor III may perform technical document reviews and other GCP activities in support of project work or company processes. Additionally, the Quality Assurance Auditor III provides finished audit reports to management, plans and delivers billable quality services for clients and projects and may serve as the client contact.

What You'll Do:

• Conduct and/or lead a variety of client, internal or GCP audits and regulatory inspections as requested by senior management
• Lead directed site audits, facility, vendor and/or sub-contractor audits
• Provide GCP consultation and support to project teams and external clients
• Lead process audits and may participate as a co-auditor in more complex system audits
• Perform other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement)
• Contacted by others to serve as a resource to operational departments on audit or quality assurance subject matter
• Prepare and present audit findings and/or other related information at departmental, internal operations or client meetings
• Provide mentorship and guidance to junior auditors

Education & Experience Requirements:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous GCP QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’).
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities:

• Detailed knowledge of GCP and appropriate regional research regulations and guidelines
• Demonstrated proficiency and led a range of project based or internal GCP audits and vendor audits to high standards required by management
• Excellent oral and written communication skills
• Strong problem solving, risk assessment and impact analysis abilities
• Solid experience in root cause analysis
• Above average negotiation and conflict management skills
• Flexible and able to multi-task and prioritize competing demands/work load
• Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

Working Conditions and Environment:

• Work is performed in an office/ laboratory and/or a clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment required such as protective eyewear, garments and gloves.

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.