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Technical Specifications Specialist

Thousand Oaks, CA
“This company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to this company, its operations, or its staff.”

Top 3 Must Have Skill Sets:    
  • Analytical procedure knowledge, technical writing, communication
  • Change control records is a plus
Day to Day Responsibilities:        
  • To create or revise raw material specifications, facilitate technical meeting for raw material specification development, own change controls related to raw material specifications
Summary
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 this company (with Process Development, Quality, Supply Chain and other GMP functions). Draft specifications based on raw material attributes, where they are used in the company 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); preference will be given to advance degree holders and/or those who have industry and project management experience.

Basic qualifications:
Bachelors degree in science related field with some work experience
Masters or PHD in science related field
"This posting is for Contingent Worker, not an FTE"

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