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Senior QA Specialist

Cytiva

Miami, FL
28 days ago

Job Description

As a Senior QA Specialist at Cytiva, you will oversee QMS management and batch release, ensuring compliance and supporting cross-functional teams on projects. This role is crucial for driving quality assurance in life sciences and biotechnology.

Key Responsibilities

  • Represent QA in cross-functional projects
  • Support the organization within QMS processes such as Change Control, CAPA, NC, and batch release
  • Review and approve Change Control, CAPA, NC
  • Perform batch release
  • Approve qualification activities
  • Participate in cross-functional risk assessments
  • Drive improvement activities within the QMS

Required Qualifications

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