Quality Control Analyst

Overview

This position is based in Waterford, Ireland, on a fixed-term contract lasting 23 months within the Quality Control (QC) team. QC ensures all products meet CGMP standards by testing samples from intermediate production, final products, raw materials, and environmental sources. The team also supports investigations, training, change controls, validation, and equipment qualification, alongside contributing to broader site projects and studies.

Main Duties

• Perform analytical testing punctually while adhering to scheduled plans.
• Comply fully with cGMP and Health, Safety & Environmental (HSE) requirements, following all relevant procedures and documentation practices.
• Accurately record raw data, calculations, and relevant information in line with cGMP and data integrity standards.
• Maintain up-to-date training and qualification for assigned tests.
• Conduct timely quality control reviews of test results from peers.
• Promptly report any quality or HSE incidents such as deviations or out-of-specification outcomes to management for investigation and impact assessment.
• Engage actively in investigations ensuring comprehensive analysis with appropriate assessments.
• Implement corrective and preventive actions (CAPAs) linked to remediation and continuous performance improvement.
• Ensure laboratory facilities and instruments are maintained in safe, quality-compliant conditions.

Candidate Profile

• Academic qualifications: Bachelor of Science in Chemistry, Biochemistry, or related scientific fields.
• Experience working in an analytical chemistry laboratory environment.
• Strong technical knowledge of cGMP practices and laboratory safety protocols.
• Proficiency in analytical testing techniques and data review.
• Understanding of data integrity principles and regulatory compliance.
• Experience with biologics and chromatographic methods such as HPLC/UPLC, CE, ICE.
• Attention to detail and precision in documentation and reporting.
• Effective communication skills to collaborate and report findings.
• Problem-solving skills applied to quality and deviation investigations.
• Dedication to quality assurance and adherence to safety standards.
• Ability to work collaboratively within multidisciplinary teams.

Equal Opportunities Commitment

The company promotes diversity, equity, and inclusion, providing equal opportunity employment regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.