QC Material Management (Sample Management and Buffer Preparation) Specialist - Dublin

My client, a world class biologics multinational, is seeking to recruit a QC Material Management Analyst to join the QC Site Operations team at its Multi-Product Cell Culture Drug Substance Facility in Dublin. 

Reporting to the QC Material Management Supervisor, they will be responsible for supporting site activities related to the Sample Management/Buffer Preparation Laboratory, in-process samples, and laboratory duties in accordance with cGMP regulations.

The main responsibilities for this position include;

• Liaise with manufacturing to ensure all Drug Substance samples are processed and delivered to the appropriate destination in an appropriate timeframe.

• Liaise with Engineering Stores to ensure all Drug Product samples are processed and delivered to the appropriate destination in an appropriate timeframe.

• Manage TempTales and shipping documents when receiving samples from external sites.

• Log in of samples to LIMS/CIMS or logbooks, and label accordingly.

• Release samples for QC testing.

• Storage of backups and reserve samples.

• Perform monthly reconciliation and report deviations to Sample Management Lead, if any.

• Aliquot samples for the QC activities for Global Biologics Laboratory and Multi Product Cell Culture Facility.

• Buffer preparation activities for the QC Laboratories.

• Generate and update SOPs and other relevant documents as required.

• Maintain a high standard of GMP compliance including the completion and provision of training as required.

• Keeps abreast of current corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing.

• Performing any other activities as indicated by the Lab Supervisor.

The successful candidate must demonstrate excellent written and verbal communication skills and the ability to work in a team based collaborative environment.

The ideal candidate should hold a minimum of a third level qualification (Degree) in Chemistry/Biology or related discipline.