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Quality Engineer 3

United States, Sandy · Job Posted May 29, 2026
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Job Description

Support quality remediation initiatives through CAPA management and GMP compliance activities. Perform technical writing, document review, and risk assessment activities in a regulated environment. Collaborate with cross-functional teams to ensure timely completion of quality deliverables.

Job Responsibility

  • Develop, manage, and execute CAPA records aligned with regulatory and internal quality standards
  • Perform technical writing and detailed review of investigations, protocols, and reports
  • Ensure GMP compliance across quality and documentation deliverables
  • Identify compliance gaps, risks, and improvement opportunities
  • Collaborate with SMEs and cross-functional teams to support timely CAPA closure
  • Contribute to risk assessments and risk management activities using a science-based approach
  • Support inspection-ready documentation and quality processes
  • Maintain project timelines and deliverables

Requirements

  • Experience in GMP-regulated environments preferred
  • Strong experience with CAPA processes and quality remediation activities
  • Experience in technical writing and document review within regulated industries
  • Familiarity with risk assessment and risk management practices preferred
  • ICH Q9 experience is an advantage
  • CAPA management
  • GMP compliance
  • Technical writing and document review
  • Investigation and report review
  • Risk assessment and risk management
  • Cross-functional collaboration
  • Problem-solving and analytical skills
  • Time management and organization
  • Bachelor’s degree in Life Sciences, Pharmacy, Engineering, Quality, or related field preferred
  • Experience in pharmaceutical, biotech, or regulated manufacturing environments preferred
  • Ability to work independently and manage multiple deliverables

Nice to have

  • Experience in GMP-regulated environments preferred
  • Familiarity with risk assessment and risk management practices preferred
  • ICH Q9 experience is an advantage

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