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Systems Quality Specialist

Company: Thermo Fisher Scientific
Location: Greenville
Posted on: February 13, 2019

Job Description:

Job Title: System Quality Specialist

Requisition ID: 86607BR

When youre part of the team at Thermo Fisher Scientific, youll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and youll be supported in achieving your career goals.

Location/Division Specific Information

Greenville, SC

How will you make an impact?

Provide Quality Assurance review/oversight for GXP computer systems. This position will provide QA support and validation oversight for implementation, validations, and system upgrades/modifications of the computer systems that relate to the review and generation of documents supporting regulatory, validation, and clients in which to maintain quality and improve efficiency.

What will you do?

  • Provide quality oversight and compliance support to implement and validate electronic systems in accordance with the corporate and site procedures and requirements.
  • Develop or review protocol, plans, scripts, reports etc. associated with the implementation and maintenance of computerized systems.
  • Provide QA oversight during risk, Part 11 and Annex 11 and regulatory assessments.
  • Review changes to validated state of system through the change control and participate in planning and implementing changes.
  • Stakeholder in the development, implementation, and continued improvement of quality systems within the QA department.
  • Participates as a Subject Matter Expert with systems such as Event Tracking Tool (Trackwise), Electronic Document Management System (Documentum), Laboratory Information Management System (CoreInformatics), Learning Management System (SuccessFactors), Continuous Process Verification (Discoverant).
  • Assist with Data Integrity audits and Document Control activities when required.

    How will you get here?


    • Bachelors Degree in Life Sciences or equivalent experience.


      • 2+ years in a regulatory environment - required
      • Extensive knowledge of FDA/EMA regulatory requirements applicable to drug product/substance pharmaceutical manufacturing. Ability to apply GMP regulations and other international guidelines to all aspects of the position.
      • Technical knowledge of pharmaceutical manufacturing, validation, raw materials, analytical testing, and materials management is desirable
      • Working knowledge of controlled documentation and data systems.
      • Able to obtain DEA registration.

        At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer.

        Apply today!

        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.

        Keywords: Thermo Fisher Scientific, Greenville , Systems Quality Specialist, Other , Greenville, South Carolina

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