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Job ID :
71562BR
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 II will perform surveillance testing of finished goods including data generation, product stability verification, data analysis and summarization, instrument operation, and other QC lab supporting activities. Responsible for all aspects of laboratory operations, such as sample receipt, data generation, product verification, data analysis and summarization, out-of-specification investigations, instrument qualifications, and all other QC lab supporting activities.


What will you do?

  • Conduct analytical and functional testing of finished good kits according to approved SOPs as part of QC Surveillance testing.
  • Perform testing using chemistry clinical analyzers and document test results accurately using Excel spreadsheets and workbooks.
  • Perform testing according to established time points and ensure timelines are met, as required per the standard procedure.
  • Initiate out of specification investigations, as needed.
  • Perform stability testing protocols on newly launched products, as well as on market products.
  • Document test results, complete batch records, document problems and other relevant information under cGMPs.
  • Perform simple revisions and updates to QCs SOPs and/or worksheets as necessary, and initiate procedure change orders.
  • Assist in performing validation testing for QC processes and laboratory equipment.
  • Assist in performing stability testing of new product raw materials that have been implemented.
  • Participate in brainstorming activities, perform problem-solving and basic data analysis related to QC failures.
  • Interpret and summarize test data, maintain lot histories and evaluate data for trends and discrepancies.
  • Perform other responsibilities to support the needs of the department as assigned by Supervisor.
  • Participate in PPI, Lean, and 5S programs, as required.


How will you get here?

  • Minimum BS/BA in Chemistry, Biochemistry, or Bioscience with 2-4 years of Quality Assurance/Quality Control experience, preferably in the medical diagnostics industry.
  • Demonstrated ability and/or additional experience may be considered in lieu of a BS/BA degree.
  • Strong laboratory skills including pipetting, safety, and hazardous chemical handling.
  • Understanding of cGMP and how it applies to the work environment is preferred.
  • 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.




If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.

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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