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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 PuertRictbe vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers 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 this company, its operations, or its staff.”

Top 3 Must Have Skill Sets:                        
  • Communication skills, critical thinking, background in Life Science or Engineering (Biochemistry, Analytical Chemistry, Bio-Manufacturing, Process development, Chemistry, Biology, Engineering).
Day to Day Responsibilities:        
  • Own Material Specification activities
  • Draft specifications based on raw material attributes, where they are used in the this company process and how they should be controlled
  • Facilitate specification development meetings
  • Generate meeting minutes/action items to partners to ensure completion of tasks
  • Own Master Data onboarding activities
  • Create and own Master Data Changes in Trackwise
  • Determine master data strategy for inclusion on BOMs
  • Ensure Animal Derived Material tissue and origin correctly identified in SAP
  • Manage material creation workflows by ensuring SAP data agents complete all tasks on time to meet onboarding need-by date
  • Coordinate with site warehouse, purchasing and accounting teams
  • Ensure material status is updated for use at manufacturing sites
Summary
Manage the development and implementation of clinical and commercial raw material specifications, material master data, and other specification related documents.

Have an understanding and knowledge of the raw materials used in the manufacturing of biologics and small molecules (Media, Chemicals, Excipients, Single-Use Components, Filters, Resins).
Understand and develop the strategy for functionally equivalent materials for inclusion on production BOMs and material master data setup
Interface cross-functionally within this company (with Process Development, Quality, Supply Chain and other GMP functions)
Other responsibilities include Quality System record ownership including change control, master data change control, deviation, and CAPA

Degree in Life Science or Engineering (Biochemistry, Analytical Chemistry, Bio-Manufacturing, Process development, Chemistry, Biology, Engineering).

"This posting is for Contingent Worker, not an FTE"

 

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