Quality Control Analyst

2 weeks ago

Dublin, Dublin City, Ireland Next Generation Full time
Overview

QC Material Management Analyst to join the QC Site Operations team at a Multi-Product Cell Culture Drug Substance Facility in Dublin. Reporting to the QC Material Management Supervisor, you will support site activities related to performing testing of Raw Materials, in-process samples, and laboratory duties in accordance with cGMP regulations.

Responsibilities
  • Perform QC testing (TOC, pH, conductivity) of water samples, and analysis of Raw Materials including HPLC, KF, UV, IR, and wet chemistry techniques. Complete laboratory documentation in a timely and accurate manner as directed.
  • Ensure compliance with Standard Operating Procedures and Registered Specifications.
  • Assist in authoring and reviewing documentation, including SOPs, as required.
  • Review batch paperwork and reconcile analyses performed in the laboratory, ensuring any out-of-specification results are investigated according to procedures.
  • Support technical transfer of new projects.
  • Assist with out-of-specification investigations and deviations using the Infinity system.
  • Perform sample management activities and ensure chain of custody is maintained using CIMS and LIMS.
  • Keep up to date with current industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing.
  • Carry out other activities as indicated by the Lab Supervisor.
Qualifications
  • Third level qualification (Degree) in Chemistry, Biology, or related discipline.
  • At least 2-3 years of experience in a pharmaceutical or healthcare laboratory or related technical function.
  • Strong written and verbal communication skills, with the ability to work effectively in a collaborative team environment.
Next steps

If this position is of interest, please submit your CV to Barry O'Mahony from Next Generation Recruitment using the apply button.

Next Generation will never share your data outside of our organisation without your prior written consent. Please read our Data Protection Policy on our website. If you require any reasonable accommodations during the recruitment process please let us know and we will do our best to support you.


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