JO-2504-550701 NEW ROLE : Our client, an early-stage contract research organization requires a Senior In Vitro Bioassay Analyst to join their expanding team in Ballina.
Reporting to the Biosafety & Cell Based Assay Supervisor.
Role Leading the execution of routine cell-based potency assaysSupport technical transfer, qualification and validation of new cell-based assaysMaintenance and propagation of antibiotic free cell cultures.Evaluation of mammalian cells / Generation and maintenance of mammalian cell banks.Establishment of Test Method SOPs and validation of methodsCore duties shall include: Maintenance and propagation of antibiotic free cell cultures.Competent in microscopic evaluation of mammalian cells (e.g.
cell morphology, count and viability)Provide technical training to team as required.Receipt and processing of test samples in LIMS.Update current standard operating procedures.Assist in laboratory investigations where necessary.Responsible for reporting progress information to Management.Assist in internal, regulatory and client visits/audits and respond to findings.Complete understanding of all regulatory guidelines.Liaise with the Quality Department for the generation of all departmental quality documents including audit responses, facility replies and deviation reports.Generation of GMP compliant SOPs, Protocols and reportsGenerate risk assessments for laboratory and test items as required.Maintain Laboratory Data Integrity and compliance
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