QC Analyst – Analytical NPI: Method Transfer & Validation

Alexion Pharma Spain S.L.; Dublin; Hybrid; EUR 40,000 - 70,000; Full time

Job summary

AstraZeneca in Ireland (Dublin) is seeking a QC Analyst to join the Analytical New Product Introduction team, executing method transfers and validations to ensure compliant testing from day one and robust data integrity.

You will troubleshoot methods, enable instrumentation improvements, maintain training, author high‑quality technical reports, and collaborate with QC, Development, and Manufacturing to secure steady‑state testing and timely release of therapies.

Qualifications

• BSc in Chemistry or biological sciences with 2–3 years’ experience.
• Experience in method transfer and validation in a cGMP environment.
• Experience with chromatographic/spectroscopic techniques desirable.
• Ability to use AI tools in regulated writing while maintaining compliance.

Responsibilities

• Analytical Method Transfer and Validation: execute transfers and validation per protocols, ensuring accuracy, precision and compliance for QC deployment.
• cGMP Compliance: perform all lab activities to cGMP standards with data integrity and audit readiness.
• Method Troubleshooting and Investigations: lead troubleshooting of new methods and investigations to resolve aberrant results.
• Instrumentation and Technology Enablement: troubleshoot instrumentation and introduce fit-for-purpose technologies.
• Data Integrity and Reporting: report aberrant results, author technical reports, support risk assessments and change controls.
• Training and Readiness: maintain current training and uplift team capability.
• Stakeholder Partnership: collaborate across QC, Development, and Manufacturing for smooth tech transfer.
• Continuous Improvement: drive initiatives to streamline workflows and reduce deviations.

Skills

Biochemistry/Chemistry knowledge

Investigation & troubleshooting

Procedure compliance

Technical writing

AI in regulated writing

Independent worker

Education

BSc in Chemistry or Biological Science

Tools

HPLC/UPLC

CE

UV

IR

LIMS/ELN

DOE

Job description

AstraZeneca in Ireland (Dublin) is seeking a QC Analyst to join the Analytical New Product Introduction team, executing method transfers and validations to ensure compliant testing from day one and robust data integrity.

You will troubleshoot methods, enable instrumentation improvements, maintain training, author high‑quality technical reports, and collaborate with QC, Development, and Manufacturing to secure steady‑state testing and timely release of therapies.