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Job ID :
57938BR
Location :
US - California - Fremont
:
Job Description

As the world’s leader in serving science, Thermo Fisher Scientific is a driving force in the research, healthcare, industrial and applied markets, generating more than $18B in annual revenue. No other company can match our range of customer touch points – technologically, geographically or commercially. We help our customers in finding cures for cancer, protecting the environment, making sure our food is safe and moving forward with thousands of important projects that improve millions of lives.



Position Summary:

This position is responsible for receiving Device History Records and ensuring that they are completed with Good Documentation Practice and maintained in a controlled environment. In addition to DHR, the clerk will also maintain Quality and Regulatory records and making sure that it’s available for review as needed.


Key Responsibilities:

  • Responsible for receiving and maintenance of Device History Records (DHRs).
  • Ensure that files are accurate and complete with Good Documentation Practice.
  • Data entry of DHRs.
  • Maintain files of Regulatory Standards or Corporate Policies.
  • Provide document retrieval support for customers
  • Assist Manufacturing and QA/QC Operations departments in expediting required documentation for product releases, i.e Cerfificates of Analysis.
  • Provide weekly metrics to identify any potential gap within the process for improvement
  • Provides support on various projects or tasks delegated by the Senior Change Analyst or Document Control Supervisor.
  • Able to establish and maintain proactive and professional relationships with all levels of personnel.
  • Generate Validation Protocol numbers as requested.
  • Provide lab notebooks and tracking number to R&D.
  • This position has the authority to limit access to documents maintained in Document Center.


Minimum Requirements/Qualifications:

  • Completion of High School, vocational training or equivalent.
  • Clerical experience is helpful.
  • Familiar with Quality System Regulation/cGMP, and ISO requirements.
  • Ability to lift and/or move up to 20 lbs.
  • Ability to work in a high pressured deadline oriented environment.
  • Able to sit, stand and/or use keyboard for long periods of time.
  • Must be able to communicate with various positions in the company, and have excellent reading, writing and basic math skills as well as an aptitude for detail oriented work requiring a high degree of accuracy.
  • Must have the skills to work as a strong contributor in a team effort.
  • Excellent customer service and listening skills. A
  • Accurate typing/Word processing skills.
  • Working knowledge of PCs and Microsoft Office.

At Thermo Fisher Scientific, each one of our 55,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.




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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