QA Auditor II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join us as Associate Quality Assurance Auditor - And play a crucial role in ensuring compliance and excellence in our clinical auditing processes.
What You’ll Do:
• Conduct a variety of routine client, internal or GxP audits
• Assist or may conduct non-complex process audits
• Perform other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, facility audits, process improvement)
• Serve as a resource to operational departments on audit or quality assurance subject matter
• Assist in the preparation of audit findings and/or other related information
Education and Experience:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification; Associate degree and relevant experience is acceptable in lieu of bachelor’s degree
• Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 year).
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:
• Introductory knowledge of applicable GxP and appropriate regional regulations

• Working knowledge of Good Manufacturing Practice (GMP) requirements
• Working knowledge of SOPs and WPDs

• Previous experience working in a laboratory environment is preferred
• Strong oral and written communication skills (including appropriate use of medical and scientific terminology)
• Good attention to detail
• Able to work independently or in a team environment
• Good problem-solving abilities
• Good organizational and time management skills
• Basic computer skills and ability to learn and become proficient with appropriate software
• Proven flexibility and adaptability
• 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.