Qa Lead Specialist

Aldevron

Madison, WI, United States
On-site
Lead deviation and capa activities
Oversee review and release of final products
Author, maintain, and improve sops
Aldevron is seeking a QA Lead Specialist to join their Quality Assurance team in Madison, WI. The successful candidate will have significant experience in an ISO 13485 environment, leading quality initiatives, and mentoring staff, all while contributing to life-changing innovations in the biotechnology sector

Job Summary

  • Lead, mentor, and train Quality Assurance staff, serving as the subject matter expert.
  • Lead quality events and CAPAs, drive to root cause, and contribute to continuous improvement initiatives.
  • Provide front-room support during audits (ISO 13485, internal, and client audits).

Matching Summary

Match Score: 85

Aldevron is seeking a QA Lead Specialist to join their Quality Assurance team in Madison, WI. The successful candidate will have significant experience in an ISO 13485 environment, leading quality initiatives, and mentoring staff, all while contributing to life-changing innovations in the biotechnology sector.

Skills & Requirements

Must-have

  • Lead deviation and CAPA activities
  • Oversee review and release of final products
  • Author, maintain, and improve SOPs
  • Create working schedule for QA staff
  • Provide front-room support during audits

Nice-to-have

  • Background in Continuous Improvement
  • Background in Lean Manufacturing

Key Requirements

  • 6 years experience in ISO 13485 and/or GxP environment
  • 3 years experience with root cause analysis and/or technical writing
  • Bachelor of Science in Biology, Biochemistry, or related field

Work Rights

Not specified

Tailored Resume

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