Quality Assurance Analyst

hace 1 mes

Porriño, Pontevedra, España Lonza A tiempo completo

Company Overview: Lonza is a prominent global entity in the life sciences sector, operating across multiple continents. Our approach to science is rooted in collaboration, leveraging the talents of our people to create innovative solutions that enhance business operations and improve lives.

Position Summary: The Quality Control Specialist serves as a key expert in designated areas, acting as the primary QC representative and liaison between the QC Laboratory and both internal and external stakeholders. This role involves managing moderately complex assignments that require sound judgment and initiative to address challenges and provide recommendations.

Key Responsibilities:

  • Serve as the Quality Control representative on various internal and customer project teams.
  • Monitor QC testing processes, manage project timelines, and coordinate analytical discussions while resolving issues.
  • Compile and present product data to stakeholders, driving necessary process changes and managing deviations.
  • Lead projects to ensure timely completion.
  • Initiate and finalize process change controls, deviations, and laboratory investigation reports.
  • Oversee technical transfers and method validations within the laboratory setting.
  • Independently determine methodologies for new assignments and provide guidance to other QC personnel.
  • Ensure readiness for regulatory and customer inspections, participating in audits as required.
  • Provide backup supervision when necessary.
  • Engage in non-routine assignments, problem-solving, and project management.
  • Perform additional duties as assigned.

Qualifications:

  • Preferred Associate's or Bachelor's degree in a science-related field or relevant industry experience in Quality Control.
  • Knowledge of Good Manufacturing Practices (GMP) is essential.
  • A minimum of 2 years of experience in quality roles is required.
  • Proficient communication skills in English are necessary.
  • Prior laboratory experience is preferred.
  • Experience in protocol writing is advantageous.
  • Familiarity with report writing, documentation control, and Standard Operating Procedure (SOP) review is preferred.
  • Experience with LIMS, Trackwise, and Empower systems is beneficial.

Conclusion: At Lonza, we recognize the significant impact our products and services have on millions of lives. We believe that achieving our business goals ethically is paramount. Our team is driven by the challenge of solving complex problems and innovating within the life sciences field, offering the rewarding experience of making a meaningful difference globally.

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