Catalyx is seeking a QC Analyst to join our team and work on our customer site in Waterford.

WHO WE ARE:

Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services RD, production, packaging, and delivery processes—globally—with a sophisticated blend of products, technologies, and lifecycle services. The company was formed in 2022 after CXV Global (Crest Solutions, Xyntek, and VistaLink) and Panacea Technologies joined forces. For over three decades, Catalyx’s partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety. To learn more about the company’s experience and comprehensive suite of capabilities and solutions, visit www.catalyx.ai.

REQUIREMENTS:

• Degree in Chemistry, Analytical Science, or a related discipline.
• Experience in analytical testing within a GMP-regulated pharmaceutical or biopharmaceutical environment.
• Hands-on expertise with particle characterisation techniques such as FTIR, Raman spectroscopy, and SEM.
• Strong knowledge of cGMP and cGLP requirements.
• Familiarity with method development, validation, and maintenance of SOPs and technical documentation.
• Ability to conduct and support OOS and deviation investigations.
• Strong communication and collaboration skills, with the ability to work across multidisciplinary teams.
• Detail-oriented, self-motivated, and adaptable.

THE ROLE:

Catalyx is a trusted partner in delivering world-class lifecycle services to regulated and high-risk end markets. With a relentless commitment to innovation and excellence, we partner with life science and other highly regulated organisations, to empower them to enhance efficiency, and drive success. As part of this commitment, we are continuously developing our on-site teams to support the advancement of customer operations.
The successful candidate will be responsible for isolating particles from sterile biologics and supporting investigations into particle origin. The role will involve use of advanced analytical techniques such as FTIR, scanning electron microscopy, and Raman spectroscopy.

RESPONSIBILITIES:

• Provide analytical chemistry services and support to site operations.
• Perform particle analysis and support investigations into the source of foreign matter.
• Collaborate effectively with Quality Assurance, Production, Engineering, and Planning departments.
• Maintain, update, and issue chemical methods, specifications, and SOPs in line with regulatory and pharmacopoeial requirements.
• Train analysts in relevant methods, SOPs, and technical updates.
• Monitor and trend analytical results, complete COAs, and support OOS investigations.
• Ensure all laboratory records and documentation are accurate, current, and compliant.
• Ensure QC laboratories operate in compliance with current Good Laboratory Practice (cGLP).
• Verify that chemical testing and related equipment meet validation requirements (IQ, OQ, PQ).
• Review and audit laboratory notebooks, analytical reports, and chemistry test results to ensure compliance with cGLP and cGMP.
• Identify potential issues and highlight improvements to the QC Team Lead.