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Quality Compliance Associate

3 months ago

Fargo, United States Intellectt Inc Full time

Role: Quality Compliance Associate

Location: Fargo, North Dakota

Duration: 12 months / Full-time


Description:

  • Review Quality System records inclusive of Deviations, CAPAs, and Change controls. This would be the quality review responsible for ensuring compliance of the record to governing regulations.
  • Support generation of metrics related to the Quality System and escalate trends identified to Quality Management.

In this role, you will have the opportunity to:

  • Review Quality System records inclusive of Deviations, CAPAs, and Change controls. This would be the quality review responsible for ensuring compliance of the record to governing regulations.
  • Support generation of metrics related to the Quality System and escalate trends identified to Quality Management.
  • Assess atypical events through cross-functional collaboration to ascertain product impact.

The essential requirements of the job include:

  • Bachelor of Science in Biology, Microbiology, Chemistry, or other life science field preferred.
  • 1+ years of experience in Quality Assurance within a regulated industry. Experience in other facets of pharmaceuticals may be substituted.
  • It would be a plus if you also possess previous experience in:
  • Biologics or drug experience a bonus
  • Certification from ASQ or RAPS a plus