Senior Microbiology QC Lead | cGMP Expert

AstraZeneca plc; Ireland; On-site; EUR 65,000 - 90,000; Full time

Job summary

AstraZeneca plc in Athlone, Ireland, is seeking a Senior QC Specialist to lead microbiology and chemical product testing, oversee method transfer and verification, and qualify new laboratory equipment.

You will drive QC quality systems, investigate deviations, review data and reports, and prepare documentation for internal and regulatory audits while training colleagues to raise technical capability across the team.

Qualifications

• Degree in Microbiology, Chemistry or related discipline or equivalent experience.
• Significant experience within a cGMP Quality environment.
• Strong knowledge of sterility assurance, aseptic filling, microbiology and chemistry methods.
• Good knowledge of regulatory requirements for Microbiology and Sterility 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 ability to manage competing priorities.
• Clear written and verbal communication skills.
• Improvement mindset and interest in efficient and compliant processes.

Responsibilities

• Act as SME for microbiology and chemical product testing.
• Support method transfer, method verification and microbiology method validation activities.
• Coordinate qualification of microbiology test methods and support performance qualification of new lab equipment.
• Maintain high cGMP and GLP standards, ensuring activities meet regulatory requirements.
• Manage QC quality system records, including deviations and laboratory investigations.
• Investigate out-of-specification results using Root Cause Analysis tools.
• Develop corrective and preventive actions with Quality and other teams.
• Lead Quality Risk Assessments for microbiology activities.
• Review laboratory data, validation protocols, reports and microbial data.
• Coordinate testing activities and support timely review and authorization of results.
• Prepare annual environmental monitoring reports and present QC metrics and trends.
• Develop and maintain laboratory testing programmes, SOPs, validation documents and training materials.
• Prepare documentation for internal and regulatory audits.
• Represent Microbiology during audits and support resulting actions.
• Provide technical support to Manufacturing and Projects through investigations, validation and testing.
• Prepare and review technical reports.
• Train and support laboratory colleagues to raise capability.
• Troubleshoot laboratory issues and identify compliant solutions.
• Identify opportunities to improve laboratory efficiency.
• Keep up to date with emerging technologies, procedures and methods.

Skills

Microbiology

cGMP/GLP

Root cause analysis

Method validation

Laboratory investigations

Regulatory knowledge

Communication skills

Quality risk assessment

Education

Degree in Microbiology or related discipline

Equivalent experience

Tools

Laboratory equipment qualification

Job description

AstraZeneca plc in Athlone, Ireland, is seeking a Senior QC Specialist to lead microbiology and chemical product testing, oversee method transfer and verification, and qualify new laboratory equipment.

You will drive QC quality systems, investigate deviations, review data and reports, and prepare documentation for internal and regulatory audits while training colleagues to raise technical capability across the team.