QC Analyst, Method Transfer & Validation

Alexion Pharmaceuticals, Inc.; Dublin; Hybrid; EUR 42,000 - 66,000; Full time

Job summary

AstraZeneca is seeking a QC Analyst for the Analytical New Product Introduction (NPI) team to transfer and validate analytical methods for QC deployment. You will ensure cGMP compliance, data integrity, and rigorous troubleshooting to safeguard product release reliability.

You will work with cross-functional teams to enable robust methods, train staff, and drive continuous improvement while leveraging AI tools for technical writing within regulatory boundaries.

Qualifications

• Good technical knowledge in Biochemistry or Chemistry.
• Experience in investigation methodology and method troubleshooting.
• Ability to follow written procedures with attention to detail.
• Good report/technical writing skills.
• Ability to use AI tools to support technical writing while maintaining compliance.
• Ability to work with minimal supervision for routine duties.

Responsibilities

• Analytical Method Transfer and Validation: execute transfer/validation per protocols for QC deployment.
• cGMP Compliance: perform lab activities to cGMP standards with data integrity.
• Method Troubleshooting and Investigations: lead troubleshooting of new methods and support investigations.
• Instrumentation and Technology Enablement: troubleshoot instruments and introduce fit-for-purpose tech.
• Data Integrity and Reporting: identify aberrant results, write high-quality reports, contribute to risk assessments and change controls.
• Training and Readiness: maintain training; share knowledge to uplift team.
• Stakeholder Partnership: support NPI management and collaborate across QC, Development, and Manufacturing.
• Continuous Improvement: drive initiatives to streamline workflows and improve right-first-time outcomes.

Skills

Biochemistry/Chemistry

Investigation & troubleshooting

Procedural compliance

Technical writing

AI in writing

Independent work

Education

BSc in Chemistry or biological science

Tools

LIMS/ELN

Job description

AstraZeneca is seeking a QC Analyst for the Analytical New Product Introduction (NPI) team to transfer and validate analytical methods for QC deployment. You will ensure cGMP compliance, data integrity, and rigorous troubleshooting to safeguard product release reliability.

You will work with cross-functional teams to enable robust methods, train staff, and drive continuous improvement while leveraging AI tools for technical writing within regulatory boundaries.