QC Senior Analyst, Microbiology (12 month fixed term contract)

Alexion; Blanchardstown; On-site; EUR 65,000 - 90,000; Full time

Job summary

AstraZeneca (Alexion) in Dublin is seeking a Senior Analyst for QC Microbiology to anchor a high-performing team and elevate sterility assurance across release and stability programs. You will mentor staff, shape investigations, and translate regulatory requirements into practical routines to improve speed and compliance.

In this role you will ensure batches progress with confidence, maintain inspection-readiness, and drive continuous improvement while safeguarding quality at the source for

Qualifications

• Must have hands-on microbiology lab experience.
• Knowledge of current regulatory requirements for Microbiology/Sterility Assurance.
• Strong problem-solving and data integrity mindset.
• Ability to work in a cGMP environment and support investigations.

Responsibilities

• Plan, execute, and trend environmental monitoring and testing to verify controlled conditions.
• Perform and supervise microbiological testing for release and stability programs.
• Maintain regulatory compliance and readiness for inspections.
• Provide day-to-day troubleshooting and support to analysts in the lab.
• Lead investigations for out-of-specification results and drive CAPA actions.
• Train and develop colleagues to improve capability and consistency.
• Drive continuous improvement to reduce cycle time and improve data integrity.

Skills

Sterility testing

Regulatory knowledge

Problem solving

Laboratory skills

Education

BSc in Microbiology

Job description

Are you ready to set the microbiology standard that protects patients and keeps life-changing medicines moving? In this Dublin-based role, you will be the technical anchor for a high-performing QC Microbiology team—solving problems at pace, elevating sterility assurance, and ensuring batches progress with confidence.

You will combine hands-on expertise with structured problem solving to drive reliable release, robust stability programs, and right-first-time results. Do you thrive in a cGMP lab where your decisions keep manufacturing on schedule and inspections ready?

As a senior analyst, you will mentor others, shape investigations, and translate regulations into practical routines that improve speed and compliance over time. Your work will directly support therapies for people with serious and rare conditions by safeguarding quality at the source.

Accountabilities

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• Environmental and Facilities Monitoring: Plan, execute, and trend sampling and testing to verify controlled conditions and prevent contamination risks across cleanrooms, utilities, and critical spaces.
• Product Testing for Release and Stability: Perform and oversee microbiological testing to support product release and stability programs, ensuring data integrity and on-time decisions.
• Sterility Assurance and Compliance: Uphold high cGMP and GLP standards, align methods and records with current regulatory expectations, and be inspection-ready at all times.
• Laboratory Excellence: Maintain rigorous housekeeping and safety practices; champion adherence to SOPs, good documentation, and effective use of laboratory equipment.
• Technical Troubleshooting and Support: Provide day-to-day guidance to analysts; resolve instrument, method, and sample issues rapidly to minimize retest, deviations, and downtime.
• Investigations and CAPA: Lead or contribute to out-of-specification/limit investigations using structured problem solving and root-cause tools; implement effective corrective and preventive actions within target timelines.
• Training and Capability Building: Train laboratory personnel and contribute to the design, delivery, and evaluation of training and re-training programs that raise capability and consistency.
• Continuous Improvement: Deliver projects and initiatives that streamline workflows, reduce cycle time, and strengthen data integrity across the QC Microbiology function.
• Communication and Stakeholder Management: Keep supervisors and cross-functional partners informed on risks, progress, and emerging trends to support sound decisions and stable supply.

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Essential Skills/Experience

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• BSc in Microbiology or a biological science, with 4-7 years’ experience, or equivalent combination of education and experience.
• Experience in testing of sterile/non-sterile pharmaceutical /biopharmaceutical products.
• Good knowledge of current regulatory requirements for Microbiology / Sterility Assurance
• The duties of this role are generally conducted in an lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

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Desirable Skills/Experience

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• A working knowledge of the cGMP QC laboratory environment, and equipment associated with testing of biopharmaceutical products
• Ability to follow written procedures with close attention to detail
• Ability to function with minimal supervision for routine job duties.

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Why AstraZeneca

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At AstraZeneca, you will work where biotech agility meets global scale, close to the real stories of people living with rare and serious conditions. You will join a collaborative culture that puts integrity and inclusiveness first—unexpected teams in the same room unleashing bold thinking, backed by cutting-edge science and the resources to deliver. We value kindness alongside ambition, pairing rigorous standards with genuine care for colleagues and the people who depend on our medicines. Your craftsmanship in microbiology will directly protect patients while opening paths to learn, lead, and innovate.

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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.