As a Senior QA Specialist at Cytiva, you'll play a vital role in ensuring compliance with quality management systems and supporting cross-functional projects. Your expertise will help drive improvements in processes that impact life-saving innovations in the biotechnology field.
Key Responsibilities
Represent QA in cross-functional projects for new products and equipment
Support the organization within QMS processes like 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, 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, and/or GMP)
Experience as QA in projects
Experience of Qualification activities within automation, equipment, and analytical methods
Experience in risk assessments/FMEA, batch release, and deviations/NC