Quality Control Analyst (Cell Culture)

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

The QC Analyst (Quality Operations) will report directly to the QC Manager and will help in the expansion of the Laboratory and complete analytical method transfers and validation as well as commercial testing.

Duties:

• Work as directed by the QC Manager / Associate Director, according to Company safety policies, cGMP and cGLP.
• Required to drive compliance with company’s Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
• Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc
• Participate in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various Quality systems; ensure all work is carried out in line with same
• Operate as part of the QC team performing the allocated testing and laboratory-based duties
• Perform various analytical techniques including but not limited to HPLC, (HIC, CE, IEX, HP-SEC), ELISA, Cell Based Assay, Cell Culture, Capillary Electrophoresis and other compendial test methods in compliance with GMP requirements
• Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved
• Ensure timely completion of all assigned data processing and reviewing.
• Participate in the laboratory aspects of OOS investigations
• Provide support with audit/inspection requirements to ensure department compliance/readiness.
• Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
• Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why's etc,
• Work collaboratively to drive a safe and compliant culture on site.

• Bachelors Degree or higher preferred; ideally in Analytical Chemistry/ Biochemistry or a closely related discipline.
• The ideal candidate will have 2- 3 years’ experience in a pharmaceutical laboratory, ideally with experience in Cell based assays and relevant systems and software. Core to the role is to perform testing of samples to support the release of our key drug products.
• A good working knowledge of Immunoassay, Cell Culture, HPLC systems and software is desirable
• A good knowledge of cGMP, GLP, Quality Management Systems