Quality Control Specialist

Life Science Recruitment; Leinster; On-site; EUR 40,000 - 60,000; Full time

Job summary

Life Science Recruitment is seeking an Associate Specialist Quality Control for an award-winning pharmaceutical organisation in Carlow. The role focuses on environmental monitoring, trend analysis, and ensuring regulatory compliance within a GMP environment.

You will develop and execute microbiology methods, manage risk assessments, and contribute to continuous improvement initiatives across the site. A Bachelor's in Microbiology or related field and 3 years' QA/QC experience are required.

Qualifications

• Bachelor’s degree in Microbiology, Biology, Biotechnology, Pharmaceutical Science, or related Life Sciences.
• Minimum 3 years’ hands‑on experience in microbiology/QC, especially environmental monitoring and utilities monitoring.
• 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.

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.

Skills

Environmental monitoring

Trend analysis

Data analysis

Regulatory compliance

Troubleshooting

Change controls

Documentation

Lean lab initiatives

GLIMS experience

Education

Bachelor's degree in Microbiology or related Life Sciences

Tools

GLIMS

Electronic laboratory systems

Job description

Associate Specialist Quality Control

Onsite days

RK26596

Contract 11 months

Carlow

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.

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.