Quality Control Associate

3 weeks ago


Omaha, United States Insight Global Full time

Must Haves:

  • 2-4 years experience
  • USDA 9CFR (OR FDA 21CFR)
  • Industry experience (Zoetis, GSK, J&J, Li-COR)
  • 4 year degree in a science field
  • Experience within quality control testing
  • Knowledge and experience working with assays (ELISA would be a plus)
  • Strong experience within aseptic techniques
  • Deviation Management system: writing and helping with investigations, change controls, root cause analysis
  • Strong experience revising/updating SOPs revise/update and managing the process of internal employees updating


Plusses:

  • Working at a USDA facility
  • Previous experience or knowledge with LIMS systems
  • Previous experience testing environmental monitoring programs

Duties:


Day to Day:

Insight Global is seeking a Quality Control Associate for an Animal Vaccine R&D and manufacturing site in Elkhorn, NE. This position will be responsible for Lab Investigations and quality control testing and monitoring environmental programs. In addition they will later be involved in deviation management, CAPA management, Change Control Management, Annual Product Reviews/Periodic Quality Reviews (or even better yet Annual Outline Reviews which is specific to USDA regulated sites). Ideally the candidate will have worked in a FDA/USDA regulated environment in the past, has lab experience, and knowledge of GMP requirements. The company is in the process of expansion plans and the team is in need of someone who will be providing support for internal teams that have had an increase in project demand. The ideal candidate will be a team player, is eager to learn more about the industry, and expand their knowledge on process analysis & support.



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