Quality Assurance Specialist

hace 2 semanas

Porriño, Pontevedra, España Lonza A tiempo completo

About Lonza

Lonza is a global leader in life sciences, operating across three continents. Our success is built on the talent and expertise of our people, who work together to develop innovative solutions that improve lives around the world.

Job Summary

We are seeking a Quality Assurance Specialist to join our team. As a subject matter expert, you will be responsible for ensuring the quality of our products and services, and for acting as a liaison between our QC Laboratory and internal and external customers.

Key Responsibilities

  • Participate in multiple internal and customer project teams as Quality Assurance representative
  • Track QC testing, manage project commitments, follow through on action items, coordinate analytical teleconferences and participate in problem solving of issues
  • Track and compile product data and present to internal and external customers and drive associated process change controls/deviations
  • Independently drive projects to on-time completion
  • Initiate and complete necessary process change controls, deviations and laboratory investigation reports
  • Responsible for tech transfers and methods validation in the laboratories
  • Act independently to determine methods and procedures on new assignments and may provide guidance and oversee the activities of other QC personnel
  • Ensure regulatory and customer inspection readiness and represent the department and participate in audits as required
  • Provide supervisor backup, if needed
  • Work on non-routine assignments, problem solving, manage project commitments
  • Perform other duties as assigned

Key Requirements

  • Associate's or Bachelor's degree preferred in science related field, or industry based experience in Quality Assurance
  • GMP knowledge required
  • Minimum 2 years of previous quality experience required
  • Communication skills in English required
  • Previous lab experience preferred
  • Experience with protocol writing preferred
  • Experience with writing reports, documentation control, and SOP review preferred
  • Experience with LIMS, Trackwise, Empower preferred

About the Role

This is a challenging and rewarding role that requires a high level of expertise and judgment. As a Quality Assurance Specialist, you will have the opportunity to work on complex problems and develop new ideas in life sciences. You will be part of a team that is dedicated to improving lives around the world, and you will have the satisfaction of knowing that your work is making a meaningful difference.

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