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Job ID :
44463BR
Location :
US - California - Fremont
:
Job Description

Position Summary:

Manufactures products and completes associated documentation. Contributes to the transfer of new products into Manufacturing. Participates in process improvement projects.


Key Responsibilities:

  • Manufacture products such as reagents, calibrators, buffers, and controls and complete batch records following cGMPs.
  • Review and approve completed batch records.
  • Perform in-process assays using clinical analyzers. Review and analyze data.
  • Will weigh, transfer, and mix chemicals
  • Perform product filtrations.
  • Maintain and analyze lot histories for trends and discrepancies.
  • May train other chemists on equipment and procedures.
  • May write, review, and modify SOPs, work instructions and reports.
  • Maintain, troubleshoot and validate equipment as appropriate.
  • Execute process validations as appropriate.
  • Keep department lead or manager updated on all issues.
  • Monitor stocks of common lab supplies.
  • Perform other job duties as required.


Minimum Requirements/Qualifications:

  • BS/BA in scientific discipline (biology/biochemistry) with 0-2 years of related experience and/or training preferred. AA degree with 2-4 years related experience may be substituted.
  • Basic lab skills and knowledge of safety precautions.
  • Familiarity with Quality System Regulations.
  • Experienced working with potentially hazardous chemicals and human source materials.
  • Must be able to lift 25 lbs routinely.
  • May be required to lift up to 50 lbs occasionally.


Non-Negotiable Hiring Criteria:

  • This position does not offer relocation assistance
  • Must be in compliance with GMP, QSRs, ISO and IVD regulations in the performance of department responsibilities.
  • Strong laboratory skills including pipetting, safety, and hazardous chemical handling.
  • Must be organized and detail oriented to be able to prioritize own and other’s work and meet business productivity metrics.
  • Self sufficient, self-motivated, and focused.



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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