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Job ID :
62192BR
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?

Using standard operating procedures (SOP) and good manufacturing practices (GMP), the Engineer/Scientist III, QC will perform routine and non-routine testing of raw materials, as well as stability testing of raw materials. Receive general instructions on routine work and detailed instruction on new assignments. Provide guidance and training to junior Engineer/Scientists. This position will perform various laboratory operation tasks such as sample receipt, data generation, product verification, data analysis and summarization, out-of-specification investigations, instrument qualifications, and other QC lab supporting activities.


What will you do?

  • Conduct analytical and functional testing of raw materials, intermediates, finished goods kits and/or filled bottle reagents/calibrators according to approved SOPs.
  • Act independently to determine methods and procedures on new assignments.
  • Perform testing using chemistry clinical analyzers and document accurate test results using spreadsheets and workbooks.
  • Perform stability testing protocols.
  • Perform initial troubleshooting of issues which arise during routine analysis, and perform out of specification investigations. If needed, initiate non-conformance reports, CAPAs, deviations or variances.
  • Document test results, complete batch records, document problems and other relevant information under cGMPs.
  • Review and approve documentation completed by other QC Engineer/Scientists.
  • Summarize test data, maintain lot histories and analyze for trends and discrepancies.
  • Perform revisions and updates to SOPs and initiate document change orders.
  • Participate in interdepartmental and team meetings to support new product development, validations, and sustaining projects.
  • Participate in PPI and 5S programs to drive continuous improvements.
  • Perform other responsibilities to support the needs of the department as assigned by the Supervisor.


How will you get here?

  • Bachelor in Chemistry, Biochemistry, or related discipline with at least 5 years Quality Assurance/Quality Control experience, preferably in the medical diagnostics or in a regulated industry.
  • Strong laboratory skills including pipetting, safety, and hazardous chemical handling.
  • Understanding of cGMP and how it applies to the work environment.
  • Must be able to write clear, understandable documentation.
  • Ability to follow written and verbal directions with a high level of accuracy.
  • High level of reading comprehension skills. Ability to follow written and verbal directions with a high level of accuracy.
  • Must be able to write clear, understandable documentation.
  • High level of verbal communication skills.
  • Manual dexterity, must be able to lift/move up to 20 pounds.
  • Intermediate word processing and spreadsheet software skills.
  • Ability to manage multiple tasks simultaneously.
  • Ability to work independently.
  • Ability to perform simple data analysis and to summarize results.
  • Basic math skills including calculation of concentrations and dilutions and a strong grasp of algebraic concepts.


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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