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QA Auditor I

91320505MA20EKDC2K PPD Laboratories (Suzhou), Co., Ltd · Suzhou, China

Audit & TaxationExternal listingfull-time7 days ago

About The Role

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 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

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.

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