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Quality Control Officer
2 weeks ago
Quality Control Officer 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: Project Management of routine batch release testing in the Biosafety and Cell Based Assay Department (client correspondence, weekly calls, management of subcontractors, ensuring samples are released within the required timelines i.e.
scheduling of tests, review of basic data, liaising with QA, generation of CoA etc.
)Generation and updating of GMP compliant SOPs, Protocols and reports.Sourcing, purchasing and stocking consumables, standards and reagents required for testing.Receipt and processing of test samples in LIMS.Carry out data calculations, basic statistics and trending.
Provide additional information at the clients request as required.Assist in internal, regulatory and client visits/audits and respond to findings.Requirements: Min 2 years relevant experience in Scientific Research preferably within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry.Experience in project management essential.BSc/M.Sc in a relevant science discipline (e.g.
cell biology / Molecular Biology / Biomedical Science).Experience in cell-based assays / molecular techniques desirable but not essential.
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