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