QC Analyst, Analytical NPI (12 month fixed term contract)

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

Are you ready to apply rigorous analytical science to accelerate the introduction of new therapies for people with rare and devastating diseases? As a QC Analyst within our Analytical New Product Introduction (NPI) team, you will bridge development and commercial QC by executing method transfers and validations that ensure robust, compliant testing from day one. Your work will directly influence product release reliability and speed, safeguarding supply continuity for patients who cannot wait.

You will join a team that values precision, curiosity, and ownership—where troubleshooting complex methods, introducing new technologies, and refining instrumentation performance are part of the daily craft. You will help reduce variability, improve right-first-time results, and strengthen data integrity across a growing portfolio. How will you use your analytical and problem-solving mindset to shorten the path from bench to patient?

Accountabilities

• Analytical Method Transfer and Validation: Execute transfer and validation activities in alignment with written protocols, ensuring methods are accurate, precise, and compliant for QC deployment.
• cGMP Compliance: Perform all laboratory activities to cGMP standards, maintaining impeccable data integrity and audit readiness.
• Method Troubleshooting and Investigations: Lead troubleshooting of new methods and support investigations to rapidly resolve aberrant results and prevent recurrence.
• Instrumentation and Technology Enablement: Troubleshoot instrumentation and introduce fit-for-purpose technologies that enhance method robustness and productivity.
• Data Integrity and Reporting: Recognize and report aberrant test results, author high-quality technical reports, and contribute to risk assessments and change controls.
• Training and Readiness: Maintain current training for all job functions; share knowledge to uplift team capability.
• Stakeholder Partnership: Support the NPI management team and collaborate across QC, Development, and Manufacturing to ensure smooth tech transfer and steady-state testing.
• Continuous Improvement: Drive continuous improvement initiatives that streamline workflows, reduce deviations, and elevate right-first-time outcomes.

Essential Skills/Experience

• Good technical knowledge in the area of Biochemistry or Chemistry.
• Good experience in investigation methodology and method troubleshooting
• Ability to follow written procedures with close attention to detail
• Good report writing and technical writing skills
• Ability to use AI tools to support technical writing (risk assessments, change controls, deviations) while understanding compliance boundarieS
• Ability to function with minimal supervision for routine job duties

Education

• BSc in Chemistry or a biological science, 2-3 years’ experience, or equivalent combination of education and experience.

Desirable Skills/Experience

• Hands-on experience with chromatographic and spectroscopic techniques (e.g., HPLC/UPLC, CE, UV, IR), compendial methods, and biologics testing.
• Demonstrated success in method transfer and validation within a cGMP environment, including protocol authorship and execution.
• Proficiency with LIMS/ELN systems and documentation standards for data integrity and audit readiness
• Working knowledge of Quality Systems (deviations, CAPA, change control) and statistical tools for method performance monitoring.
• Experience applying AI tools in regulated settings to improve technical writing efficiency without compromising compliance.
• Exposure to DOE, risk assessments (e.g., FMEA), and continuous improvement methodologies such as Lean or Six Sigma.
• Strong cross-functional communication and the ability to translate analytical findings into practical operational decisions.

Why AstraZeneca

At AstraZeneca, you will shape analytical solutions that help transform ideas into medicines for patients with the greatest need. We combine the curiosity and autonomy of a biotech with the scale and investment of a global company—unexpected teams in the same room unleashing bold thinking, backed by the tools and mentorship to deliver. We stay close to patients and close to each other, valuing kindness alongside ambition, and empowering you to take ownership, stretch beyond your lane, and grow at pace. Your contribution will be visible, meaningful, and connected to a mission that changes lives.

Date Posted

14-Oct-2026

Closing Date

27-Oct-2026

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.