QA Auditor III

ThermoFisher Scientific; Athlone; On-site; EUR 60,000 - 90,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Quality Assurance Auditor III to lead complex audits and ensure GxP compliance across projects. You will review documents, identify root causes of non-conformances, and develop corrective actions for clients and internal teams.

Ideal candidates bring 5+ years of QA auditing experience, strong regulatory knowledge, and excellent communication for client-facing deliverables in a fast-paced environment.

Qualifications

• Bachelor's degree or equivalent and QA qualification.
• 5+ years of QA auditing experience in regulatory environments.
• Detailed knowledge of GxP and GMP guidelines.

Responsibilities

• Conduct and/or lead client, internal or GxP audits and regulatory inspections.
• Lead directed site audits, facility, vendor and subcontractor audits.
• Provide GxP consultation and support to project teams and clients.
• Lead process audits and co-audit more complex system audits
• Perform other QA audits or activities (e.g., database audits, study reports, data tables).
• Serve as resource to operational departments on audit or QA matters.
• Prepare and present audit findings at meetings.
• Provide mentorship to junior auditors.

Skills

QA auditing

GxP knowledge

Regulatory compliance

Documentation review

Risk assessment

Root cause analysis

Communication skills

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 GxP 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 GxP audits and regulatory inspections as requested by senior management
• Lead directed site audits, facility, vendor and/or sub-contractor audits
• Provide GxP 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 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 GxP and appropriate regional research regulations and guidelines
• Demonstrated proficiency and led a range of project based or internal GxP audits and vendor audits to high standards required by management
• Working knowledge of Good Manufacturing Practice (GMP) requirements
• Previous experience working in a laboratory environment is preferred
• 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 is 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.