As a Senior QA Specialist at Cytiva, you will play a critical role in ensuring quality management and compliance within the life sciences sector. You will work closely with cross-functional teams to support QMS processes and drive improvement initiatives, making a tangible impact on health and safety.
Key Responsibilities
Represent QA in cross-functional projects for new products and equipment
Support QMS processes including Change Control, CAPA, NC, and batch release
Review and approve Change Control, CAPA, and NC
Perform batch release
Approve qualification activities in collaboration with the organization
Conduct 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 related to automation, equipment, and analytical methods
Experience in risk assessments/FMEA, batch release, and deviations/NC