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Senior QA Specialist

Disability Solutions

Miami, FL
26 days ago

Job Description

Join Cytiva as a Senior QA Specialist and be part of a dedicated QA team overseeing QMS management and batch release. You'll collaborate across functions to ensure compliance and make a tangible impact in life sciences, diagnostics, and biotechnology.

Key Responsibilities

  • Represent QA in cross-functional projects
  • Support the organization within the QMS processes; Change Control, CAPA, NC and batch release
  • Review and approve Change Control, CAPA, NC
  • Perform batch release
  • Approve qualification activities to meet set 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 degree in chemistry or Pharmacy or equivalent
  • Experience in similar QA role within Life Science companies (e.g., ISO 9001, ISO 13485 and/or GMP)
  • Experience as QA in projects
  • Experience in Qualification activities within automation, equipment, and analytical methods
  • Experience in QA for risk assessments/FMEA, batch release, and deviations/NC

Benefits & Perks