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Beckman Coulter

Quality Assurance Specialist II

Beckman Coulter

Fajardo, Puerto Rico · full time · Mid

Listed on Beckman Coulter’s own careers site. You apply with them directly — we never stand between you and the employer.

What this role is

This Quality Assurance role supports manufacturing operations in regulated life sciences, handling complaint investigations, nonconformance assessments, and continuous improvement at a Cytiva filtration and diagnostics facility. It suits someone with 5-10 years of pharma or medical device quality experience who wants hands-on involvement in investigations and process improvement in a compliant manufacturing environment.

Our summary, not Beckman Coulter’s wording. The full posting is on their site.

Skills this role names

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What they ask for

Required

  • Bachelor's degree in Biology, Microbiology, Engineering, or related scientific/technical discipline
  • 5-10 years experience in regulated life sciences, medical device, pharmaceutical, biotechnology, or manufacturing
  • Experience with cleanroom or controlled environment operations
  • Experience leading or supporting quality investigations, complaints, nonconformances, root cause analysis, CAPA, risk assessments, or change control
  • Proficiency with electronic quality systems and digital tools

Nice to have

  • Danaher Business System (DBS), Lean Six Sigma, or Toyota Lean System experience
  • Cleanroom Management and Controlled Environments certification or background
  • Life sciences, pharmaceuticals, or medical devices sector experience
  • Valid driver's license with acceptable driving record
  • Ability to travel up to 2%
  • Ability to lift equipment up to 10 lbs

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