Senior Quality Control Analyst

Senior QC Analyst

An opportunity has arisen for a Senior QC Analyst to become a key member of the Quality Team within a leading Biologics facility in West Dublin. The successful candidate will support key lab start up activities conducting biological, chemical and physical analysis ensuring compliance with cGMP and corporate regulations.

Key Responsibilities:

• As part of the Quality Control Testing hub you will work across the site supporting Quality, EHS, Learning and Continuous Improvement.
• Support Key lab start up activities conducting analysis.
• Collaborate with Process Development Technical Services and Manufacturing Operations
• Responsible for providing information to support the QMR decision making process.
• Collaborate across the network and continuous improvement teams across the organisation
• Create strategies and plans to manage risk within the Quality Control operation
• Identify and communicate risks in areas of responsibility and across the site.
• Ability to work across teams focusing on meeting and tracking to schedules.
• Support project delivery and operational readiness

Qualifications and Experience:

• Bachelor's Degree in Science or related
• 4 years experience in the Biotechnology/Pharmaceutical industry
• Strong Project Management skills
• Understanding of cGMP requirements for Lab Operations
• Understanding of Lab Methodology (HPLC, GC, UPLC, Capillary Electrophoresis and Wet Chemistry)
• Understanding of GMP, ICH, USP and Global Compendia regulations
• Demonstrated understanding of continuous quality/.process improvement tools.
• Ability to manage multiple priorities and know when to escalate issues for resolution
• Excellent communication skills both written and oral.

For more information and a full job description please forward your CV in the strictest confidence to [email protected]