My client 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.
Reporting to the QC Material Management Supervisor, they will be responsible for supporting site activities related to Sample Management Laboratory, in-process samples, and laboratory duties in accordance with cGMP regulations.
The role:
1. Liaise with manufacturing to ensure all Drug Substance samples are processed and delivered to the appropriate destination in an appropriate timeframe.
2. Liaise with Engineering Stores to ensure all Drug Product samples are processed and delivered to the appropriate destination in an appropriate timeframe.
3. Liaise with Warehouse Cryogenics Logistics (WCL) to ensure all Raw Material samples are processed and delivered to the appropriate destination in an appropriate timeframe.
4. Manage TempTales and shipping documents when receiving samples from external sites.
5. Log in samples to LIMS/CIMS or logbooks, and label accordingly.
6. Release samples for QC testing.
7. Store backups and reserve samples.
8. Perform monthly reconciliation and report deviations to Sample Management Lead, if any.
9. Aliquot samples for QC activities in the Global Biologics Laboratory and Multi Product Cell Culture (MPCC) Facility.
10. Perform QC testing (TOC, Nitrates, Conductivity) of water samples and analysis of Raw Materials using techniques like HPLC, KF, UV, IR, and wet chemistry. Complete laboratory documentation accurately and timely as directed by the QC Material Management Supervisor.
11. Ensure compliance with Standard Operating Procedures and Registered Specifications.
12. Assist in authoring and reviewing documentation, including SOPs, as required.
13. Review batch paperwork and reconcile analysis performed in the laboratory. Investigate any out-of-specification results according to site procedures.
14. Generate and update SOPs and other relevant documents as needed.
15. Maintain high GMP compliance standards, including completing and providing training as required.
16. Stay informed of current industry and corporate requirements related to laboratory operations and aseptic manufacturing.
17. Perform any other activities as indicated by the Lab Supervisor.
Qualifications & Experience
* The successful candidate must demonstrate excellent written and verbal communication skills and the ability to work collaboratively in a team environment.
* The ideal candidate should hold at least a third-level qualification (Degree) in Chemistry/Biology or a related discipline, with a minimum of 1 year of experience in a pharmaceutical or healthcare laboratory or related technical role.
The Next Step for you:
If interested, please submit your CV to Barry O'Mahony from Next Generation Recruitment using the apply button.
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