Senior QC Analyst - 24 Month Secondment/FTC

AstraZeneca; Athlone; Presencial; EUR 65.000 - 85.000; Jornada completa

Descripción de la vacante

AstraZeneca in Athlone is seeking a Senior QC Analyst (Microbiology) to provide technical microbiology expertise across testing, environmental monitoring, and method validation. You will help ensure safe, compliant operations and support continuous improvement in the Microbiology Laboratory.

You will collaborate withQuality, Manufacturing and Projects, lead investigations, and contribute to regulatory compliance while keeping up-to-date with new microbiology technologies and regulatory

Formación

• Degree in Microbiology or related science.
• Significant experience in a cGMP quality environment.
• Experience testing sterile drug products and aseptic filling.
• Strong knowledge of regulatory requirements for Microbiology and Sterility.
• Expertise in method validation, endotoxin testing and sterility testing.
• Experience with Quality Risk Management.
• Knowledge of LIMS and microbiology system implementation.

Responsabilidades

• Provide technical expertise for microbiology testing and environmental monitoring.
• Support validation and qualification of test methods and systems.
• Lead quality risk assessments and maintain cGMP/GLP standards.

Conocimientos

Microbiology expertise

Root Cause Analysis

Collaboration

Planning & organization

Educación

Degree in Microbiology or related discipline

Herramientas

LIMS

Descripción del empleo

Senior QC Analyst, Microbiology

Location: Athlone

Shift: Week 1: 07:00–15:15 , Monday to Friday Week 2: 14:45–23:00 , Monday to Friday

Are you ready to make an impact in Quality Control?

We are looking for an experienced QC Analyst, Microbiology to join our team in Athlone.

In this role, you will provide technical expertise across microbiology testing, environmental monitoring, method validation and new technologies. You will act as a subject matter expert, helping us maintain high standards while supporting safe, compliant and efficient laboratory operations.

You will collaborate with colleagues across Quality, Manufacturing and Projects, giving you the opportunity to share your expertise and contribute to continuous improvement.

What you will do

As part of our QC team, you will:

• Provide technical expertise for microbiology testing and environmental monitoring.
• Support the validation and qualification of microbiology test methods and systems, including endotoxin and identification systems.
• Partner with the QC System Specialist to develop and implement LIMS within the Microbiology Laboratory.
• Lead and contribute to Quality Risk Assessments.
• Maintain strong cGMP and GLP standards and support regulatory compliance.
• Create and maintain laboratory testing programmes, SOPs, validation documentation and training materials.
• Support internal and external audits and ensure actions are addressed effectively.
• Investigate out-of-specification and out-of-limit results using Root Cause Analysis tools.
• Develop and implement effective corrective and preventative actions.
• Review laboratory data, validation protocols and technical reports.
• Review and authorise microbial data.
• Provide technical support to Manufacturing and project teams through investigations, validation and testing activities.
• Train and support laboratory colleagues, helping us build capability across the team.
• Keep up to date with new microbiology technologies, methods and regulatory expectations.
• Troubleshoot laboratory issues and identify practical solutions.
• Support initiatives that improve laboratory efficiency and ways of working.
• Help ensure laboratory instruments and equipment remain calibrated and operational.
• Support the effective running of the laboratory when required.
• Represent the Microbiology Laboratory at internal and external meetings and audits.

What you will bring

We are looking for someone with:

• A degree in Microbiology or a related scientific discipline or equivalent experience.
• Significant experience in a cGMP Quality environment.
• Experience testing sterile drug products and supporting aseptic filling processes within pharmaceutical or biopharmaceutical manufacturing.
• Strong knowledge of current regulatory requirements for Microbiology and Sterility Assurance within cGMP operations.
• Subject matter expertise in method validation, endotoxin testing and sterility testing.
• Experience in Quality Risk Management.
• Knowledge of LIMS, including experience supporting the setup or implementation of LIMS within a microbiology environment.

It would be great if you also have

• Strong technical knowledge of Sterility Assurance, aseptic filling and microbiology methods.
• A collaborative approach and the ability to build effective relationships across different functions and sites.
• Strong problem-solving and Root Cause Analysis skills.
• An improvement mindset, with an interest in making processes both efficient and compliant.
• Good planning and organisational skills.
• The ability to prioritise your work and delegate appropriately.
• Clear written and verbal communication skills.

Why join us?

You will have the opportunity to use your microbiology expertise in a role where your work makes a real difference. You will collaborate with teams across the organisation, contribute to important technical and quality decisions, and help us continuously improve how our laboratory operates.

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.