QC Senior Specialist, Operations (12 month fixed term contract)

Are you ready to turn complex analytical challenges into decisive actions that protect product quality for patients? Do you want to lead cross functional problem solving and see your decisions directly safeguard supply in a high impact, fast paced environment?

Based at College Park, Dublin, Ireland, you will shape the performance of our QC laboratories across microbiology, chemistry, and biochemistry. You will drive investigations to closure, elevate method performance, and ensure that changes and improvements land with rigor and speed. Your work will connect the details of data with the realities of manufacturing and patient need, strengthening our ability to deliver consistently and compliantly.

This role requires a flexible schedule and may include weekend work and travel.

Accountabilities

• Analytical investigations and deviations: Lead and manage complex laboratory investigations and deviations to rapid, data driven closure, ensuring robust root cause analysis and sustainable CAPAs that protect product quality and release timelines.
• Method troubleshooting and SME leadership: Serve as a subject matter expert across analytical chemistry, biochemistry, and/or microbiology methods; troubleshoot issues, stabilise performance, and mentor colleagues to elevate technical capability.
• Change control and CAPA delivery: Own and drive complex change controls and corrective actions from definition through implementation, minimising disruption while strengthening compliance and control.
• Cross functional problem solving: Convene and lead diverse teams across QC, manufacturing, and technical functions to resolve complex issues, accelerate improvements, and embed best practices.
• Method lifecycle and performance monitoring: Support continuous monitoring of analytical method performance, identifying trends, preventing recurrence of issues, and optimisation of methods across their lifecycle.
• Laboratory operations support: Contribute to APQR compilation and review, change control and investigation review, and process improvements that streamline QC operations and documentation flow.
• Standardisation across laboratories: Ensure alignment of product analytical test procedures across internal and external laboratories, enabling consistency, comparability and reliable decision making.
• Reference standards oversight: Manage the site Reference Standard Programme, ensuring availability, qualification and compliant use to underpin data integrity.
• Regulatory support and inspection readiness: Support regulatory submissions, requests and responses; actively prepare for and participate in audits and inspections, demonstrating control, traceability and scientific rigour.
• Communication and risk management: Provide clear, timely updates to senior management; escalates risks early and presents options and recommendations to drive resolution.
• Continuous improvement projects: Deliver projects that enhance laboratory efficiency, digital systems use and right first time execution, translating insights into measurable performance gains.

Essential Skills / Experience

• Advanced understanding of the laboratory environment and familiar with laboratory techniques associated with the analysis of biological drug products.
• Ability to understand and follow written SOPs, record all work legibly and in real time; close attention to detail is necessary.
• Self initiative and ability to work independently.
• Experience leading cross functional teams and complex analytical activities.
• Advanced organisational and communication skills.
• Ability to work collaboratively with colleagues, peers and managers.
• Good understanding of the concepts and systems applied to the tests and cGMP operations.
• B.A./B.Sc. or equivalent in Biological Sciences, Chemistry or other biotechnical science, or equivalent experience in regulated industry.
• Preferable 5-8 years experience within a biotech, pharmaceutical or biopharmaceutical manufacturing environment.
• Proven communication skills including providing communications to higher level management.
• Ability to work independently as well as a member of a team in a dynamic, fast paced environment.

Desirable Skills / Experience

• Flexibility to travel.
• Experience in technical issue resolution and working on cross functional teams.
• Excellent organisational skills.
• Experience of LIMS, EQV, Empower and documentation systems would be an advantage.

Why AstraZeneca

Here, your quality expertise fuels a mission with real urgency-getting critical medicines to people living with serious and often overlooked conditions. You will partner with scientists, engineers, and quality leaders who put patients at the centre of every decision. We blend the pace and autonomy of a biotech with the scale and discipline of a global biopharma, bringing unexpected teams into the same room to unleash bold thinking that is grounded in integrity and cGMP excellence. We value kindness alongside ambition, and we invest in your growth with access to cutting edge technology, supportive leaders and opportunities to shape how QC delivers for patients and the business.

Call to Action

If you are ready to lead high stakes QC investigations in Dublin and turn complex analytics into lasting impact for patients, send your CV and take the next step today!

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 perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.