Senior QC Specialist - 24 Month Secondment/FTC

Alexion Pharmaceuticals, Inc.; Athlone; In loco; EUR 65.000 - 90.000; Tempo pieno

Descrizione del lavoro

Alexion Pharmaceuticals, Inc. in Athlone seeks a Senior QC Specialist to lead microbiology and chemical testing, method transfers, and equipment qualification. You will ensure cGMP/GLP compliance, manage investigations, and drive improvements across QC operations.

The role involves coordinating environmental monitoring, reviewing data and regulatory documentation, and mentoring laboratory staff to build technical capability across the team.

Competenze

• Degree in Microbiology, Chemistry or related discipline or equivalent experience.
• Significant experience within a cGMP Quality environment.
• Strong technical knowledge of Sterility Assurance, aseptic filling, microbiology and chemistry methods.
• Good knowledge of current regulatory requirements for Microbiology and Sterility Assurance within cGMP operations.
• Subject matter expertise in method validation, endotoxin testing and bioburden testing.
• Strong problem-solving and Root Cause Analysis skills.
• Ability to build collaborative relationships across different functions and sites.
• Strong organisational skills and the ability to manage competing priorities.
• Clear written and verbal communication skills.
• An improvement mindset and an interest in developing processes that are both efficient and compliant.

Mansioni

• Act as a subject matter expert for microbiological and chemical product testing.
• Support method transfer, method verification and microbiology method validation activities.
• Coordinate the qualification of microbiology test methods and support the performance qualification of new laboratory equipment.
• Maintain high cGMP and GLP standards, ensuring activities meet regulatory and business requirements.
• Manage QC quality system records, including deviations and laboratory investigations.
• Investigate out-of-specification and out-of-limit results using Root Cause Analysis tools.
• Develop effective corrective and preventative actions in partnership with Quality and other teams.
• Lead and contribute to Quality Risk Assessments for microbiology activities.
• Review laboratory data, validation protocols, reports and microbial data.
• Coordinate testing activities and support the timely review and authorisation of results.
• Prepare annual environmental monitoring reports and present QC metrics and environmental monitoring trends to QC and site leadership.
• Develop and maintain laboratory testing programmes, SOPs, validation documents and training materials.
• Prepare documentation for internal and regulatory audits.
• Represent the Microbiology team during audits and support the completion of resulting actions and recommendations.
• Provide technical support to Manufacturing and Projects through investigations, validation and testing activities.
• Prepare and review technical reports.
• Train and support laboratory colleagues, helping us continue to build technical capability across the team.
• Troubleshoot laboratory issues and identify effective, compliant solutions.
• Identify and implement opportunities to improve laboratory efficiency.
• Keep up to date with emerging technologies, procedures and methods within microbiology.

Conoscenze

Microbiology

cGMP

Sterility

Endotoxin testing

Bioburden testing

Method validation

Root Cause Analysis

Collaboration

Organisation

Communication

Process improvement

Formazione

Bachelor's degree in Microbiology

Chemistry or related discipline

Descrizione del lavoro

Senior QC Specialist, Microbiology

Location: Athlone

Are you ready to bring your microbiology expertise to a senior Quality Control role?

We are looking for a Senior QC Specialist to join our QC team in Athlone.

In this role, you will be a subject matter expert across microbiological and chemical product testing, method transfer and verification, and the qualification of new laboratory equipment.

You will also play an important part in our QC quality systems, leading investigations, reviewing environmental monitoring trends and helping us continuously improve our laboratory operations.

Working with colleagues across Quality, Manufacturing and Projects, you will use your technical expertise to help us maintain high standards of quality, compliance and performance.

What You Will Do

• Act as a subject matter expert for microbiological and chemical product testing.
• Support method transfer, method verification and microbiology method validation activities.
• Coordinate the qualification of microbiology test methods and support the performance qualification of new laboratory equipment.
• Maintain high cGMP and GLP standards, ensuring activities meet regulatory and business requirements.
• Manage QC quality system records, including deviations and laboratory investigations.
• Investigate out-of-specification and out-of-limit results using Root Cause Analysis tools.
• Develop effective corrective and preventative actions in partnership with Quality and other teams.
• Lead and contribute to Quality Risk Assessments for microbiology activities.
• Review laboratory data, validation protocols, reports and microbial data.
• Coordinate testing activities and support the timely review and authorisation of results.
• Prepare annual environmental monitoring reports and present QC metrics and environmental monitoring trends to QC and site leadership.
• Develop and maintain laboratory testing programmes, SOPs, validation documents and training materials.
• Prepare documentation for internal and regulatory audits.
• Represent the Microbiology team during audits and support the completion of resulting actions and recommendations.
• Provide technical support to Manufacturing and Projects through investigations, validation and testing activities.
• Prepare and review technical reports.
• Train and support laboratory colleagues, helping us continue to build technical capability across the team.
• Troubleshoot laboratory issues and identify effective, compliant solutions.
• Identify and implement opportunities to improve laboratory efficiency.
• Keep up to date with emerging technologies, procedures and methods within microbiology.

What You Will Bring

• A degree in Microbiology, Chemistry or a related scientific discipline or equivalent experience.
• Significant experience within a cGMP Quality environment.
• Strong technical knowledge of Sterility Assurance, aseptic filling, microbiology and chemistry methods.
• Good knowledge of current regulatory requirements for Microbiology and Sterility Assurance within cGMP operations.
• Subject matter expertise in method validation, endotoxin testing and bioburden testing.
• Strong problem-solving and Root Cause Analysis skills.
• The ability to build collaborative relationships across different functions and sites.
• Strong organisational skills and the ability to manage competing priorities.
• Clear written and verbal communication skills.
• An improvement mindset and an interest in developing processes that are both efficient and compliant.

It would be great if you also have

• Experience in Quality Risk Management.

Why join us?

This is an opportunity to bring your technical expertise to a role where you can make a meaningful contribution to our QC operation.

You will collaborate with teams across the organisation, tackle complex laboratory challenges and help us strengthen the processes that support quality and compliance. We value new ideas and give you the opportunity to contribute to how we continuously improve the way we work.

Date Posted

07-Oct-2026

Closing Date

21-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.