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Job ID :
62193BR
Location :
US - California - Fremont
:
Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll 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 you’ll be supported in achieving your career goals.


How will you make an impact?

The Staff Scientist, Quality Control is responsible for working within the Immuno Assay group to use standard operating procedures, and good manufacturing practices, to lead the testing of routine and non-routine analysis of in-process materials and finished products. Provide guidance and leadership to junior QC Scientists as well as lead project improvements.


What will you do?

  • Perform troubleshooting during routine product analysis.
  • Document test results, problems and other relevant information, while providing guidance to junior staff.
  • Review and approve testing documentation completed by other QC staff.
  • Conduct routine analysis of intermediates and finished good materials according to approved SOPs.
  • Assist Tech Ops in developing specifications and procedures for use by QC.
  • Participate in interdepartmental meetings, such as new product meetings, troubleshooting, to represent Quality Control.
  • Revise and update SOPs as necessary.
  • Maintain and analyze lot histories for trends and discrepancies.
  • Initiate and perform investigations as part of NCARs, CAPAs, Deviations, OOS, customer complaints, when required.
  • Participate in raw material, process, and equipment/instrument validations.
  • Ensure timely and accurate release Certificate of Analysis for Direct Sales and OEM Customers
  • Determine Process Gaps in the QC process and find mechanism to ensure improvements
  • Actively communicate with QC Supervisor on Practical process improvements for QC in line process, or areas that may benefit lab culture and productivity.
  • Work with Planning, Manufacturing Services, and Production to ensure scheduling of inbound and outbound materials are processed accordingly.
  • Participate in any hiring or training of new junior QC Scientists.
  • Perform other responsibilities to support the needs of the department as assigned by Manager.

How will you get here?

  • Minimum BS/BA in Chemistry, Biochemistry, or Bioscience with at least 7-8 years Quality Assurance/Quality Control experience, preferably in the medical diagnostics industry.
  • Strong technical troubleshooting skills.
  • Strong laboratory skills including pipetting, safety, and hazardous chemical handling.
  • Strong understanding of cGMP and lab procedures.
  • Ability to follow written and verbal directions with a high level of accuracy.
  • Able to work independently using good judgment, and mentor other junior staff.
  • Proficient Word and Excel.


At Thermo Fisher Scientific, each one of our 65,000 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.


Apply today! http://jobs.thermofisher.com


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.




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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