-
Job Description
Cell Culture Analyst position available in a Pharmaceutical organization based in Carlow, requiring 2 years of experience in handling cell culture and methodologies in a GMP setting.
As a Cell Culture Analyst, you will work as directed by the Quality Control Manager / Associate Director, ensuring compliance with Global policies, procedures, and guidelines, and regulatory requirements. You will perform routine cell culture maintenance, plan and oversee cell culture activities, and develop, implement, and maintain procedures that comply with appropriate regulatory requirements.
Key responsibilities include:
- Performing routine cell culture maintenance
- Planning and overseeing cell culture activities
- Developing, implementing, and maintaining procedures that comply with appropriate regulatory requirements
- Ensuring that all Quality Systems within the department are adhered to on a daily basis
- Operating as part of the QC team performing the allocated testing and laboratory-based duties
- Participating in laboratory management (equipment, stocks, cleaning)
- Ensuring timely completion of all assigned data processing and reviewing
- Ensuring timely completion of Laboratory Investigation Reports and deviations through site procedure
- Participating in QC Tier 1 daily meetings and ensuring effective communication of testing progress, deviations, etc.
- Peer reviewing testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved
- Where applicable, reviewing, approving, and trending test results
- Participating in the laboratory aspects of OOS investigations
- Ability to lead/mentor team of lab analysts
- Driving continuous improvement, performing root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues
Education and Experience:
- 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