Quality Control Specialist

Life Science Recruitment; Leinster; On-site; EUR 55,000 - 75,000; Full time

Job summary

Life Science Recruitment is seeking a skilled Microbiology QC specialist for an award-winning pharmaceutical organization based in Carlow, Ireland. The role focuses on supporting Environmental monitoring programs and regulatory compliance to ensure continuous manufacture of quality products.

You will own environmental monitoring risk assessments, develop test methods, and drive improvements across validation studies, trending, and deviations, ensuring data integrity and regulatory alignment.

Qualifications

• Bachelor's degree in Microbiology, Biology, Biotechnology, Pharmaceutical Science, or related Life Sciences field.
• Minimum 3 years of hands-on experience in microbiology/QC, environmental monitoring and utilities monitoring.
• Ability to author procedures, change controls, deviations, reports, and work with regulatory/compendial requirements.
• Familiarity with ALCOA(+) data integrity principles, electronic laboratory systems, and controlled documentation.
• Strong troubleshooting, decision-making, and ability to drive improvements such as lean lab initiatives and method optimization.
• Strong microbiology background and understanding of aseptic processing and environmental monitoring in sterile manufacturing.

Responsibilities

• Support the environmental control program by trend analysis and corrective/preventative actions.
• Own environmental monitoring risk assessments and qualification.
• Generate quarterly and annual trend reports.
• Apply regulatory/compliance and compendial requirements to role.
• Develop and execute Microbiology test methods and project validations.
• Troubleshoot issues during validation studies and routine tests.
• Develop training modules for staff.
• Provide Microbiology support to site investigations and projects.
• Drive Continuous Improvement initiatives, including lean lab efforts and method optimization/redevelopment.
• Author and manage change controls, procedures, test methods and deviations.
• Authorize results for microbiological samples to support batch release.
• Update GLIMS system as needed.
• Assess compendial and quality manual updates for Microbiology Lab and environmental control.
• Support lab stock management and financial control as required.
• Interpret customer needs and identify solutions to non-standard requests.
• Make decisions within guidelines and policies affecting microbiology projects.

Skills

Environmental monitoring

Data analysis

Regulatory compliance

Problem solving

Communication

Education

Bachelor's degree in Microbiology

Tools

GLIMS

Change control systems

Job description

We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

This role provides technical support to the QC Microbiology Lab & operations to ensure the continued manufacture and supply of quality pharmaceutical products in meeting the priorities of Compliance, Supply, Strategy and Profit Plan.

Key Responsibilities

• Supporting the environmental control program by trend analysis and implementation of appropriate corrective and preventative measures.
• Supporting and owner of Environmental monitoring risk assessments and qualification.
• Generation of quarterly and annual trend reports.
• Understanding and applying regulatory/compliance and compendial requirements to their role together with remaining current on upcoming regulatory and compliance changes.
• Development and execution of Microbiology test methods and project validations.
• Troubleshooting of issues which arise during the execution of validation studies and routine tests.
• Development of training modules.
• Microbiology Support to Site Investigations and projects relating to environmental monitoring and utilities monitoring.
• Driving Continuous Improvement initiatives, including lean lab initiatives, method optimization/redevelopment.
• Authoring and managing change controls, procedures, test methods and deviations.
• Result authorization for microbiological samples to support batch release.
• GLIMS System updates.
• Assessing compendial and quality manual updates pertaining to the Microbiology Lab & environmental control.
• Supporting lab stock management and financial control as required.
• Interpreting customer needs, assessing requirements, and identifying solutions to non-standard requests.
• Making decisions within guidelines and policies which impact microbiology projects.

Education and Experience

• Bachelor’s degree in Microbiology, Biology, Biotechnology, Pharmaceutical Science, or a related Life Sciences field.
• Minimum 3 years of hands‑on experience in microbiology/QC, specifically in environmental monitoring and utilities monitoring, supporting site projects, trending, risk assessments, and data analysis.
• Ability to author procedures, change controls, deviations, reports, and work in line with regulatory/compendial requirements.
• Familiarity with ALCOA(+) data integrity principles, electronic laboratory systems, and controlled documentation.
• Strong troubleshooting, decision‑making, and ability to drive improvements such as lean lab initiatives and method optimization.
• Strong microbiology background and strong understanding of aseptic processing, environmental monitoring programs, and contamination control in sterile manufacturing.