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Job ID :
51356BR
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.


Position Summary:

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


Key Responsibilities:

  • Manufacture advanced products and complete batch records following SOPs
  • Ensure compliance at all times in accordance with cGMP including GDP.
  • Products include controls and calibrators; may include reagents
  • Perform in-process assays using clinical analyzers. Review and analyze data.
  • Weighing, transferring, and mixing of chemicals as required.
  • Perform product filtrations.
  • Review and approve completed batch records.
  • Maintain and analyze lot histories for trends and discrepancies.
  • Primary trainer for other chemists on equipment and procedures.
  • May write, review, and modify SOPs, work instructions and reports.
  • Maintain, troubleshoot and validate equipment as appropriate.
  • Write, review, and execute process validations as appropriate.
  • Keep department lead or manager updated on all issues.
  • Technical expert for all products and serve as a technical resource for team.
  • Initiate, investigate, evaluate, and resolve deparment non-conformances
  • May participate in CAPA
  • Perform MRP transactions for work orders and inventory.
  • Perform other job duties as required.


Minimum Requirements/Qualifications:

  • BS/BA in life scientific discipline (biology/biochemistry) with 2-4 years of related industry experience.
  • Solid lab skills and knowledge of safety precautions.
  • Good experience with Quality System Regulations and cGMP.
  • Must be in compliance with GMP, QSRs, ISO and IVD regulations in the performance of department responsibilities.
  • Experience manufacturing In-Vitro Diagnostic products a plus
  • Experience working with potentially hazardous chemicals and human source materials.
  • Strong laboratory skills including pipetting, safety, and hazardous chemical handling.
  • Must be able to lift 25 lbs routinely;May be required to lift up to 50 lbs occasionally.
  • Must be able to walk and/or stand for extended periods of time
  • Detail oriented, organized, self-motivated and focused; be able to prioritize own and other’s work as needed to meet business productivity metrics.

At Thermo Fisher Scientific, each one of our 50,000 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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