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My client, an early-stage contract research organization based in Ballina, requires a Quality Control Officer to join their Biologics Division. Reporting into the Biosafety and Cell Based Assay Department Manager.
Responsibilities:
1. Project management of routine batch release testing in the Biosafety and Cell Based Assay Department, including client correspondence, weekly calls, management of subcontractors, and ensuring samples are released within required timelines (scheduling tests, reviewing basic data, liaising with QA, generating CoA).
2. Generation and updating of GMP compliant SOPs, protocols, and reports.
3. Sourcing, purchasing, and stocking of consumables, standards, and reagents required for testing.
4. Receipt and processing of test samples in LIMS.
5. Carrying out data calculations, basic statistics, and trending; providing additional information to clients as required.
6. Assisting in internal, regulatory, and client visits/audits, and responding to findings.
Requirements:
* Minimum 2 years of relevant experience in scientific research, preferably within a GMP regulated environment (EMEA/FDA) in the Pharmaceutical, Medical Device, or CRO industry.
* Experience in project management is essential.
* BSc in a relevant science discipline (e.g., Cell Biology, Molecular Biology, Biomedical Science).
* Experience in cell-based assays or molecular techniques is desirable but not essential.
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