QC Analyst - Material Management - Dublin

QC Analyst - Material Management - Dublin

Atrium is looking for several QC Analysts to join the site operations/raw materials team onsite in Dublin. You will work as part of the Multi-Product Cell Culture Drug Substance Facility and be responsible for sample management, sample testing of raw materials in accordance to cGMP regulations.,
· 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.
· Liaise with Warehouse Cryogenics Logistics (WCL) to ensure all Raw Material 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 (MPCC) Facility.
· Performing QC testing (TOC, Nitrates, Conductivity) of water samples. Performing analysis of Raw Materials including HPLC, KF, UV, IR and wet chemistry techniques. Completion in a timely and accurate manner of laboratory documentation as directed by the QC Material Management Supervisor.
· Compliance with Standard Operating Procedures and Registered Specifications.
· Assisting in authoring and reviewing documentation, including SOPs, as required.
· Batch paperwork review, and reconciliation of analysis performed in laboratory. Ensuring that any out of specification results are investigated according to site procedures
· 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. Experience in a pharmaceutical / healthcare laboratory or related technical function/ helpful.

Click Apply now or contact Lianne to be considered for the QC Analyst - Material Management - Dublin role