QA Auditor II

Work Schedule

Environmental Conditions

Job Description

Locations considered: UK, France or Spain

Join us as Quality Assurance Auditor II - 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

• 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 GCP and appropriate regional research regulations and guidelines

• Demonstrated proficiency and led a range of project based or internal 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 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.
Apply today to help us deliver tomorrow’s breakthrough.