Quality Control Material Management Analyst

Quality Control Material Management Analyst

Dublin

New opportunity available to join our client’s QC Site Operations team at its Multi-Product Cell Culture Drug Substance Facility in Dublin. 

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

Responsibilities: 

· 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.

Qualifications: 

· Third level qualification (Degree) in Chemistry/Biology or related discipline along with at least 1 year of experience in a pharmaceutical / healthcare laboratory or related technical function

· Excellent written and verbal communication skills and the ability to work in a team based collaborative environment.