Cell Culture Analyst
RK22042
11 Months
Carlow




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.




Duties:

• Work as directed by the Quality Control Manager / Associate Director, according to Company safety policies, cGMP and cGLP. Required to drive compliance with 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.
• Perform routine cell culture maintenance
• Responsible for planning and overseeing cell culture activities
• Develop, implement and maintain procedures that comply with appropriate regulatory requirements.
• Ensure that all Quality Systems within the department are adhered to on a daily basis.
• Operate as part of the QC team performing the allocated testing and laboratory based duties.
• Participate in laboratory management (equipment, stocks, cleaning)
• Ensure timely completion of all assigned data processing and reviewing.
• Ensure timely completion of Laboratory Investigation Reports and deviations through site procedure
• Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc.
• Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved.
• Where applicable, review, approve and trend test results.
• Participate in the laboratory aspects of OOS investigations
• Ability to lead/mentor team of lab analysts
• 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,

• Bachelor’s Degree or higher preferred; ideally in a science related discipline
• 2 years prior related work in handling cell culture and cell culture methodologies preferably in a GMP Setting