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QA Auditor II

QA Auditor II

Thermo FisherMiddleton, WI, US
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QA Auditor II

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.

Become a QA Auditor II at Thermo Fisher Scientific Inc. and join a team committed to improving global health, cleanliness, and safety. Work alongside top professionals and make significant contributions to innovative projects. If you are driven and excel at what you do, we welcome you to join our dynamic team.

A Day in the Life

  • Conduct complex internal and external audits to ensure compliance with established quality assurance processes and standards.
  • Ensure adherence to global regulatory guidelines and client contractual obligations.
  • Identify issues impacting quality and regulatory compliance.
  • Support the determination of root causes of non-conformance and assist in developing strategies to address these issues.
  • Perform technical document reviews and other GxP activities in support of project work or company processes.
  • Provide completed audit reports to management.
  • Plan and deliver billable quality services for clients and projects.

Keys to Success

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').

Knowledge, Skills & Abilities :

  • Proven experience in conducting internal and external audits.
  • Knowledgable of quality assurance processes and global regulatory guidelines.
  • Ability to identify and assess quality and compliance issues.
  • Outstanding problem-solving skills to determine root causes and develop solutions.
  • Experience in technical document review and GxP activities.
  • Strong communication skills for reporting and collaboration.
  • Ability to successfully implement strategies and deliver quality services.
  • Work Environment :

    Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

    Able to work upright and stationary and / or standing for typical working hours.

    Able to lift and move objects up to 25 pounds.

    Able to work in non-traditional work environments.

    Able to use and learn standard office equipment and technology with proficiency.

    May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.

    Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

    We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

    Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

    Thermo Fisher Scientific is an EEO / Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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