Quality Control Analyst

at  Catalyx

Catalyx is seeking a QC Equipment Analyst 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 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.

SKILLS AND EXPERIENCE:

• NFQ Level 8 in a Technical Discipline (Science, Biomedical, Mechanical, Manufacturing, etc.)
• Minimum 2-3 years’ experience working in a quality or lab based role within the food, medical device or pharmaceutical industries.
• Experience validating laboratory equipment.
• Self-directed and project management skills.
• Ability to manage multiple stakeholders - this is essential as cross functional work is a daily responsibility.

THE ROLE :

This role is an ideal opportunity for an experienced Quality Control or Microbiology professional who is looking to move out of full-time lab work while still holding a connection to lab-based teams.

RESPONSIBILITIES:

• Execute and or support vendor IQ/OQ/PQ protocols.
• Establish IQ/OQ/PQ processes and execute for laboratory instrumentation and controlled temperature units.
• Support vendor IQ/OQ/PQ.
• Develop and write protocols for instrument qualification/validation studies.
• Assist in performing instrument qualification/validation assessments.
• Help troubleshoot instrument performance issues.
• Complete instrument related documents.
• Document results and write summary reports of instrument uses and qualification studies.
• Support and organize new instrument evaluation and purchase activities.
• Produce and maintain accurate and GMP compliant records.
• Support change control activities impacting QC equipment.
• Perform impact assessments when required.
• Perform investigations of equipment related deviations as needed.
• Write/Review SOPs relevant to laboratory instrument and software operation.
• Other duties as assigned.