QC Material Management Analyst

My client is seeking to recruit a QC Material Management Analyst to join the QC Site Operations team at their Multi-Product Cell Culture Drug Substance Facility in Dublin.

Reporting to the QC Material Management Supervisor, you will be responsible for supporting site activities related to performing testing of Raw Materials, in-process samples, and laboratory duties in accordance with cGMP regulations.

Key responsibilities include:

• Performing QC testing (TOC, pH Conductivity) of water samples, and analysis of Raw Materials including HPLC, KF, UV, IR, and wet chemistry techniques. Completing laboratory documentation in a timely and accurate manner as directed.
• Ensuring compliance with Standard Operating Procedures and Registered Specifications.
• Assisting in authoring and reviewing documentation, including SOPs, as required.
• Reviewing batch paperwork and reconciling analyses performed in the laboratory, ensuring any out-of-specification results are investigated according to procedures.
• Supporting technical transfer of new projects.
• Assisting with out-of-specification investigations and deviations using the Infinity system.
• Performing sample management activities and ensuring chain of custody is maintained using CIMS and LIMS.
• Keeping up to date with current industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing.
• Carrying out other activities as indicated by the Lab Supervisor.

Requirements:

• 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.

The Next Step for you:

Should this position be of interest to you please submit your CV to Barry O'Mahony from Next Generation Recruitment using the apply button.

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