QC Material Management Analyst
Supports site activities related to Sample Management Laboratory, in-process samples, and laboratory duties in accordance with cGMP regulations.
Responsibilities:
* Liaise with manufacturing to ensure timely processing and delivery of Drug Substance samples to the appropriate destination.
* Liaise with Engineering Stores to ensure timely processing and delivery of Drug Product samples to the appropriate destination.
* Liaise with Warehouse Cryogenics Logistics (WCL) to ensure timely processing and delivery of Raw Material samples to the appropriate destination.
* 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.
* Store 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.
* Generate and update SOPs and other relevant documents as required.
* Maintain a high standard of GMP compliance, including training completion and provision as necessary.
* Stay up-to-date on corporate and industry requirements and compliance trends related to laboratory operations and aseptic manufacturing.
* Perform other tasks as indicated by the Lab Supervisor.
Requirements:
* Minimum third-level qualification (Degree) in Chemistry/Biology or related discipline.
* At least 1 year of experience in a pharmaceutical / healthcare laboratory or related technical function.