Senior Microbiology QC Specialist — cGMP Leader

Alexion; Athlone; On-site; EUR 70,000 - 100,000; Full time

Job summary

Alexion in Athlone is seeking a Senior QC Specialist to bring microbiology expertise to a senior Quality Control role. You will be a subject matter expert across microbiological and chemical product testing, method transfer and verification, and qualification of new laboratory equipment.

You will drive QC quality systems, lead investigations, review environmental monitoring trends, and help continuously improve laboratory operations while collaborating with Quality, Manufacturing and Projects

Qualifications

• Degree in Microbiology, Chemistry or related discipline.
• Significant experience in a cGMP Quality environment.
• Strong knowledge of microbiology methods, sterility, and endotoxin testing.
• Experience with method validation, environmental monitoring and audits.

Responsibilities

• Act as subject matter expert for microbiology and chemical product testing.
• Support method transfer, verification and microbiology method validation activities.
• Coordinate 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.

Skills

Microbiology

cGMP

Root Cause Analysis

Quality Systems

Problem Solving

Education

Bachelor's degree in Microbiology or Chemistry or related scientific discipline

Tools

LIMS

Environmental Monitoring

Job description

Alexion in Athlone is seeking a Senior QC Specialist to bring microbiology expertise to a senior Quality Control role. You will be a subject matter expert across microbiological and chemical product testing, method transfer and verification, and qualification of new laboratory equipment.

You will drive QC quality systems, lead investigations, review environmental monitoring trends, and help continuously improve laboratory operations while collaborating with Quality, Manufacturing and Projects