Our client offers a fantastic QC Analyst opportunity for candidates interested in a new challenge in a cGMP regulatory environment. Join a supportive, growing team in the analysis of Biologics and Vaccines in a new state of the art Quality Operations laboratory. The site will manufacture and test the company’s biggest selling biologic and the biggest selling vaccine product and is a strategic manufacturing site. The QC Analyst will report directly to the QC Chemistry Manager and will help us in the start-up of this laboratory and complete analytical method transfers and validation as well as routine testing.
2 Cycle Shift
• Morning (7am -3pm Mom-Thu, 7am-2pm Friday.)
• Evening (3PM-11PM Mom-Thu, 2pm-9pm Friday.)
• Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLP. Required to drive compliance with the 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), 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.
• 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 in Carlow.
• Bachelors’ Degree or higher preferred; ideally in Analytical Chemistry/ Biochemistry or a closely related discipline.
• 2-3 years of experience in a pharmaceutical laboratory.
• A good working knowledge of HPLC systems and software is desirable.
• A good knowledge of cGMP, GLP, Quality Management Systems.
• Method validation and method transfer experience would be Advantage.
• Occasional travel may be required for training purposes.
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