Senior Microbiology QC Analyst – Impact & Innovation

Alexion Pharmaceuticals, Inc.; Athlone; On-site; EUR 60,000 - 85,000; Full time

Job summary

Alexion Pharmaceuticals, Inc. in Athlone is seeking a Senior QC Analyst, Microbiology to provide technical expertise across microbiology testing, environmental monitoring, method validation and new technologies.

You will act as a subject matter expert, supporting compliant laboratory operations, QA collaboration, audits and continuous improvement across the Microbiology Lab. The role includes reviewing data, supporting investigations, CAPA, maintaining cGMP standards and training colleagues to

Qualifications

• Degree in Microbiology or related discipline or equivalent experience.
• Significant experience in a cGMP Quality environment.
• Experience testing sterile drug products and supporting aseptic filling processes.
• Strong knowledge of regulatory requirements for Microbiology and Sterility Assurance in 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.

Responsibilities

• 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.

Skills

cGMP knowledge

Sterility testing

Microbiology methods

Education

Bachelor's degree in Microbiology or related discipline

Tools

LIMS

Job description

Alexion Pharmaceuticals, Inc. in Athlone is seeking a Senior QC Analyst, Microbiology to provide technical expertise across microbiology testing, environmental monitoring, method validation and new technologies.

You will act as a subject matter expert, supporting compliant laboratory operations, QA collaboration, audits and continuous improvement across the Microbiology Lab. The role includes reviewing data, supporting investigations, CAPA, maintaining cGMP standards and training colleagues to