QA Auditor I

Thermo Fisher ScientificRichmond, VA
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:

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
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