Role Overview
A leading biopharmaceutical organisation is seeking a QC Raw Materials Specialist to join its Quality Control Materials team at a state-of-the-art biologics manufacturing facility in Dublin.
This is an excellent opportunity to join a high-performing laboratory team supporting the manufacture of biologic drug substances. The role offers exposure to a diverse range of raw material, water, and in-process testing activities, alongside opportunities to contribute to regulatory compliance, technical transfers, laboratory documentation, and continuous improvement initiatives.
Reporting to the QC Raw Materials Manager, the successful candidate will perform laboratory testing and support site quality activities in accordance with current Good Manufacturing Practice (cGMP) requirements and established quality standards.
Key Responsibilities
- Perform routine quality control testing of water samples, including Total Organic Carbon (TOC), pH, and conductivity.
- Conduct raw material analysis using a range of analytical techniques, including HPLC, Karl Fischer (KF), UV, IR, and wet chemistry methods.
- Complete laboratory testing and associated documentation accurately and within required timelines.
- Ensure all activities are performed in compliance with approved Standard Operating Procedures (SOPs), registered specifications, and applicable quality standards.
- Author, review, and update laboratory documentation and SOPs as required.
- Review analytical results and reconcile laboratory records, ensuring out-of-specification (OOS) results are investigated in accordance with established procedures.
- Support the technical transfer and implementation of new projects and testing methods.
- Assist with OOS investigations, deviations, and other quality events.
- Manage laboratory samples and maintain accurate sample traceability and chain of custody using electronic laboratory and sample management systems.
- Maintain awareness of relevant regulatory requirements, industry standards, and compliance trends affecting laboratory operations and pharmaceutical manufacturing.
- Undertake additional laboratory duties as required by the QC laboratory management team.
Candidate Profile
The successful candidate will be detail-oriented, quality-focused, and motivated to develop their technical expertise within a collaborative, regulated laboratory environment. They will play an important role in supporting reliable testing, maintaining data integrity, and ensuring the continued quality of manufacturing operations.
Essential Requirements:
- A minimum of a third-level degree in Chemistry, Biology, or a related scientific discipline.
- At least 2-3 years of experience working in a pharmaceutical, healthcare, biopharmaceutical, or comparable technical laboratory environment.
- Practical knowledge of analytical testing techniques and laboratory documentation.
- An understanding of cGMP requirements and the importance of working in a regulated environment.
- Excellent written and verbal communication skills.
- Strong attention to detail, organisational skills, and the ability to work effectively as part of a team.
