As a Senior QA Specialist at Cytiva, you'll be integral to the QA team, overseeing QMS management and batch release. You'll collaborate with cross-functional teams to ensure compliance and drive continuous improvement, making a tangible impact in life sciences.
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 in collaboration with the organization
Represent QA in cross-functional risk assessments
Review and approve risk assessments and qualification documentation
Drive improvement activities within the QMS, projects, and processes
Ensure compliance with the Quality Management System (QMS)
Required Qualifications
Relevant Bachelor's degree in Chemistry, Pharmacy, or equivalent
Experience in a similar QA role within Life Science companies (e.g., ISO 9001, ISO 13485, GMP)
Experience in QA projects
Experience in Qualification activities within automation, equipment, and analytical methods
Experience in risk assessments/FMEA, batch release, and deviations/NC