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Environmental Conditions Office Job Description

**Competitive sign-on bonus considered for qualified candidates**

Position:

We are actively hiring experienced GCP QA Auditors Level III and above!

Locations:

Spain, UK and France (remote) Candidates must be located in one of these countries and hold the legal right to work.

Join us as a

GCP Quality Assurance Auditor III/Manager

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

GCP

audits and regulatory inspections as requested by senior management • Perform 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) • 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 Travel will be required, up to 12-15 times per year (on average 1-2 times per month) across EMEA

Essential Experience: GCP Auditing Investigator Site Audits

Other:



• 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 3+ 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 • 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.

Physical Requirements: • Ability to work in an upright and /or stationary position for 6-8 hours per day. • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. • Frequent mobility required. • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. • Ability to access and use a variety of computer software developed both in-house and off-the-shelf. • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. • Frequently interacts with others to obtain or relate information to diverse groups. • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. • Regular and consistent attendance.

Why Join Us? When you join Thermo Fisher Scientific, you become part of a integral 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.

Apply today to help us deliver tomorrow’s breakthrough.

📌 QA Auditor III (Madrid)
🏢 Thermo Fisher Scientific
📍 Madrid