QA Auditor I

Thermo Fisher Scientific • Richmond, VA

21h • Onsite

About The Position

Join us as Quality Assurance Auditor I - 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

Requirements

• 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.
• Introductory knowledge of applicable GxP and appropriate regional regulations
• Working knowledge of SOPs and WPDs
• 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
• 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.

Responsibilities

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees