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Senior QA Specialist

Cytiva

Miami, FL
28 days ago

Job Description

Join Cytiva as a Senior QA Specialist to enhance quality assurance processes in life sciences. You'll oversee QMS management, batch release, and collaborate with cross-functional teams to ensure compliance and drive continuous improvement. This is an opportunity to impact human health through innovative solutions.

Key Responsibilities

  • Represent QA in cross-functional projects
  • Support the organization within QMS processes: Change Control, CAPA, NC, and batch release
  • Review and approve Change Control, CAPA, NC
  • Perform batch release
  • Approve qualification activities to meet timelines and project plans
  • Represent QA in cross-functional risk assessments
  • Review and approve risk assessments and qualification documentation
  • Drive improvement activities within the QMS

Required Qualifications

  • Relevant Bachelor's degree in chemistry, Pharmacy, or equivalent
  • Experience in a similar QA role within Life Science companies
  • Experience as QA in projects
  • Experience in qualification activities within automation, equipment, and analytical methods
  • Experience as QA in risk assessments/FMEA, batch release, and deviations/NC