Qa Lead Specialist

Danaher Corp

Madison, Wisconsin, US
Not specified; bonus/incentive pyy eligible; compr...
On-site
6 years experience in iso 13485 environment
3 years root cause analysis experience
Bachelor of science in biology or biochemistry
Danaher Corp is seeking a QA Lead Specialist for its Aldevron division in Madison, Wisconsin. The role involves leading quality assurance activities, mentoring staff, and ensuring compliance within a life sciences context, emphasizing a culture of innovation and collaboration

Job Summary

  • This position involves leading deviation and CAPA activities while overseeing the review and release of final products within a life sciences CDMO environment.
  • The role requires mentoring Quality Assurance staff, creating work schedules, and providing front-room support during ISO 13485 and client audits.
  • Aldevron offers comprehensive benefits including medical/dental/vision insurance, 401(k), paid time off, and eligibility for bonus/incentive pay.

Matching Summary

Match Score: 85

Danaher Corp is seeking a QA Lead Specialist for its Aldevron division in Madison, Wisconsin. The role involves leading quality assurance activities, mentoring staff, and ensuring compliance within a life sciences context, emphasizing a culture of innovation and collaboration.

Salary

Not specified; Bonus/Incentive pay eligible; Comprehensive benefits package including PTO, medical/dental/vision, and 401(k)

Skills & Requirements

Must-have

  • 6 years experience in ISO 13485 environment
  • 3 years root cause analysis experience
  • Bachelor of Science in Biology or Biochemistry
  • GxP environment experience
  • Technical writing skills

Nice-to-have

  • MasterControl eQMS software experience
  • Dynamics 365 ERP software background
  • Continuous Improvement methodology knowledge
  • Lean Manufacturing background
  • Collaborative team spirit

Key Requirements

  • 6 years ISO 13485/GxP experience
  • 3 years root cause analysis experience
  • BS in Biology/Biochemistry required
  • On-site work in Madison, WI

Work Rights

Not specified

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