Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join us as Quality Assurance Auditor and enhance our clinical auditing processes by ensuring regulatory compliance and quality standards.

What You’ll Do:
• Conduct and/or lead a variety of client, internal or GxP audits and regulatory inspections as requested by senior management
• Perform 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)
• Serve as a knowledgeable 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

Education and Experience:




• 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’).

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 and Abilities:
• Thorough 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
• 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
• Adaptable and able to multi-task and prioritize competing demands/wor

📌 QA Auditor (España)
🏢 Thermo Fisher Scientific
📍 España