Senior QC Analyst, NPI & Method Transfer

AstraZeneca; Dublin; On-site; EUR 65,000 - 90,000; Full time

Job summary

AstraZeneca seeks a QC Senior Analyst focused on Analytical NPI to transfer, validate, and troubleshoot analytical methods, ensuring reliable, inspection-ready outcomes for clinical and commercial supply.

You will support rare and devastating conditions, contribute to technology adoption, and drive speed-to-patient while maintaining data integrity and compliance in a cGMP environment.

Qualifications

• In-depth knowledge of regulatory requirements for Chemistry or Biochemistry methods in support of cGMP operations.
• Good technical knowledge in Biochemistry or Chemistry.
• Experience with investigation methodologies and method troubleshooting.
• Ability to follow written procedures with high attention to detail.
• Strong report writing and technical writing skills.
• Ability to use AI tools to support technical writing while understanding compliance boundaries.

Responsibilities

• Perform cGMP laboratory functions ensuring data integrity and audit readiness.
• Lead method transfer and validation activities with regulatory and manufacturing timelines.
• Troubleshoot new methods and provide SME support for NPI activities.
• Lead investigations/CAPAs with root-cause analysis and preventive actions.
• Serve as training lead for specific assays and oversee training of new personnel.
• Drive continuous improvement to increase method robustness and reduce cycle time.
• Evaluate new analytical technologies to enhance performance and lab efficiency.
• Maintain documentation and training readiness across the method lifecycle.

Skills

Analytical methods knowledge

Investigation methodology

Data integrity

QA documentation

Technical writing

Education

BSc in Chemistry or biological science

Tools

LIMS

Empower/Chromeleon

Job description

AstraZeneca seeks a QC Senior Analyst focused on Analytical NPI to transfer, validate, and troubleshoot analytical methods, ensuring reliable, inspection-ready outcomes for clinical and commercial supply.

You will support rare and devastating conditions, contribute to technology adoption, and drive speed-to-patient while maintaining data integrity and compliance in a cGMP environment.