Quality Assurance Specialist

About Catalyx

Catalyx is a company dedicated to optimizing operational processes through scientific methods, with operations spanning North America and Europe. Established in 2022 after the merging of CXV Global and Panacea Technologies, Catalyx has a longstanding culture powering over 30 years of partnerships with organizations in production-intensive and highly regulated sectors to enhance efficiency, safety, and performance.

Role Overview

The Quality Assurance Specialist will be based on-site in Cork and work on a rotating weekly shift schedule. This position supports the delivery of lifecycle services in regulated high-risk markets, collaborating closely with life science and other regulated industry partners to improve operational efficiency and ensure quality compliance.

Key Responsibilities

• Oversee quality assurance across different stages of production, including inspection of materials, in-process checks, and product readiness verification.
• Compile and assess documentation to facilitate product release in cooperation with operational and quality teams.
• Support packaging activities through visual inspections and enforcing process compliance during regular tasks.
• Work closely with teams in manufacturing, supply chain, quality control, and engineering to address daily operational concerns and troubleshooting.
• Assist in maintaining and enhancing quality systems via managing change controls, deviations, and corrective and preventive actions (CAPA).
• Review documentation such as batch records, standard operating procedures (SOPs), and work instructions (WIs) to ensure they meet regulatory requirements and internal standards.
• Contribute to the generation of quality reports and performance metrics to track trends and support continuous enhancement.
• Participate in audits and readiness assessments to verify compliance with site and procedural requirements.
• Provide informal guidance and training on quality protocols to operational teams for effective GMP adherence.
• Engage in projects aimed at improving processes and compliance standards.
• Review and approve manufacturing inputs and documents to align with release standards.

Candidate Profile and Qualifications

• Possess a bachelor's degree in a scientific or technical field.
• Have between 2 to 4 years of professional experience in quality assurance or GMP-related roles within the pharmaceutical, biotechnology, or comparable regulated industries.
• Familiarity with batch documentation, regulatory quality systems, and FDA/EMA compliance expectations.
• Capability to analyze quality issues effectively, implement corrective measures, and escalate when necessary.
• Experience handling or supporting packaging or material management functions is an advantage.
• Strong communication skills, both written and verbal, with the ability to work collaboratively.
• Proficiency with Microsoft Office applications, especially Excel and Word.
• Highly organised with strong attention to detail and ability to handle multiple tasks simultaneously.
• Works independently within set parameters and is adaptable to changing project requirements.

Additional Information

Catalyx values its employees as its most important asset, offering a comprehensive rewards package including personal benefits and professional development opportunities. The company embraces diversity and inclusion, ensuring equitable treatment for all applicants and staff. Catalyx also supports eligible international hires with Critical Skills Visa application assistance.