As a Senior QA Specialist at Cytiva, you'll be an integral part of the QA team, ensuring compliance with quality management systems and supporting cross-functional projects. This role offers the opportunity to work on life-saving innovations while contributing to a culture of continuous improvement.
Key Responsibilities
Represent QA in cross-functional projects
Support organization within QMS processes; 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
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 in QA project roles
Experience in Qualification activities within automation, equipment, and analytical methods
Experience in risk assessments/FMEA, batch release, and deviations/NC