QC Bioassay Analyst
RK22558
Contract – 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:


• Required to drive compliance with our 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.
• Required to comply with our Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
• 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.
• Ensure timely completion of all assigned data processing and reviewing.
• Ensure timely completion of Laboratory Investigation Reports and deviations through site procedures
• Participate in the timely generation of trend data, investigations, nonconformances, validation protocols, reports in support of method validation/verifications and equipment qualifications.
• 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.
• 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.


Experience and Education:

• Bachelor’s Degree or higher preferred; ideally in a science related discipline.
• 3+ years’ experience, ideally in Quality within the Biological and/or pharmaceutical industry.
• Laboratory Quality Systems experience
• Immunoassay and cell culture experience preferable



If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.