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Technical Specifications Specialist

Thousand Oaks, CA
Day to Day Responsibilities:
  • Create and revise raw material and single use system specifications -hold meetings to discuss raw material and single use testing requirements.
Job Details:
  • Manage the development and implementation of clinical and commercial raw material specifications and other specification related documents.
  • Have an understanding and knowledge of raw materials used in the manufacturing of biologics and small molecules (Media, Chemicals, Excipients, Single-Use Components, Filters, Resins, Primary Containers).
  • Interface cross-functionally within Amgen (with Process Development, Quality, Supply Chain and other GMP functions).
  • Draft specifications based on raw material attributes, where they are used in the Amgen process and how they should be controlled.
  • Facilitate specification development meetings and generate meeting minutes/action items to partners to ensure completion of tasks.
  • Other responsibilities include acting as a change owner and initiator as part of the Change Control Management System (CCMS) to document changes to global documents in a compliant manner.
Skills:
  • Degree in Life Science or Engineering (Biochemistry, Analytical Chemistry, Bio-Manufacturing, Process development, Chemistry, Biology, Engineering).
  • Targeting candidates with 2 years work experience or more.
"This posting is for Contingent Worker, not an FTE"
 
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