Quality Assurance Specialist

Catalyx is seeking a Quality Assurance Specialist to join our team and work on our customer site in Cork.

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 R&D, 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.

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.

Responsibilities:

• Provide quality oversight across various production stages, including material inspection, in-process control, and product readiness activities.

• Assemble and review documentation to support product disposition, working closely with operational and quality colleagues to meet release timelines.

• Support packaging operations by conducting visual inspections and ensuring process adherence during routine activities.

• Collaborate with cross-functional teams (Manufacturing, Quality Control, Supply Chain, Engineering, etc.) to resolve day-to-day queries and issues efficiently.

• Contribute to the maintenance and improvement of quality systems through change control, deviation management, and CAPA oversight.

• Conduct documentation reviews such as batch records, SOPs, and WI updates, ensuring alignment with regulatory and internal standards.

• Participate in the preparation of periodic quality reports and metrics, supporting trend identification and ongoing improvement.

• Engage in internal audits and readiness assessments to ensure site and process compliance.

• Provide knowledge-sharing and informal coaching on quality processes to enable operational teams to work effectively within GMP frameworks.

• Support project-based work and initiatives aimed at process enhancement and improved compliance practices.

• Review and approve manufacturing inputs and documents to ensure compliance with release criteria.

Requirements:

• Bachelor's degree in a scientific or technical discipline.

• Minimum 3 years' experience in a Quality or GMP-related role within the pharmaceutical, biotech or related regulated sector.

• Familiarity with batch documentation, quality systems, and regulatory expectations (e.g., FDA, EMA).

• Ability to analyse issues, identify appropriate corrective actions, and escalate where necessary.

• Experience supporting or interacting with packaging or material management processes is beneficial.

• Strong written and verbal communication skills; confident working in a collaborative environment.

• Competence with Microsoft Office tools, particularly Excel and Word.

• Organised, detail-focused, and capable of managing multiple priorities.

• Comfortable working independently within defined parameters, and adaptable to shifting project needs

Why Join Catalyx?

At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities.

Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, colour, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create a welcoming environment for everyone.

At Catalyx, we are committed to attracting the best global talent. We proudly support our international employees by offering assistance with Critical Skills Visa applications for eligible candidates.