Are you a QC Analyst with 2+ years experience in a wide variety of analytical techniques including but not limited to Cell-Based Potency Bioassays, Immunoassays, Cell Culture and Aseptic Technique?This is a contract role based in Dun Laoghaire, Dublin.If you have the relevant experience, please forward your CV to karen@jobcontax.com for review or call 353-1-7978720 to discuss in confidence.QC Analyst - Biotech NPIs - DublinJob DescriptionOur client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoighaire, South Dublin.The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterization, sample and data management.Contributes to team by ensuring the quality of the tasks/services provided by selfContributes to the completion of milestones associated with specific projects or activities within teamThis role will support QC and manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.With a high degree of technical flexibility, work across diverse areas within QCPlan and perform analyses with great efficiency and accuracy.Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.Report, evaluate, back-up/archive, trend and approve analytical data.Troubleshoot, solve problems and communicate with stakeholders.Initiate and/or implement changes in controlled documents.May train others as necessaryParticipate in audits, initiatives and projects that may be departmental or organizational in scope.Write protocols and perform assay validation and equipment qualification/ verification.Introduce new techniques to the lab, including method transfers, reports, validations and protocols.May contribute to regulatory filings.May conduct lab investigations as necessary.Evaluate lab practices for compliance on a continuous basis.Approve lab resultsMay represent the department/organization on various teamsMay interact with outside resources.Create APPX data files and randomisation memo to facilitate data analysis.LIMS data coordination of commercial and import testing on site where applicableMay provide technical guidance. May contribute to regulatory filings.May represent the department/organization on various teams. May train others.May interact with outside resourcesQC Representative for NPI activities and routine Product meetingsAssist with activities related to QC projects and/or QC tasks within Site projectsPlan and perform non-core testing related to NPI activitiesManage all sample management activities related to NPI activities throughout the siteCreate/own and approve protocols, sample plans, SOP and documentation related to NPIQC Representative responsible for Method Validation and Transfers co-ordination and readinessResponsible for their own training and safety compliance.Sample shipments and temperature monitoring activities for NPI activitiesLIMS data coordination of non-core (NPI) activities.RequirementsBachelor’s degree in a Science related field is required.5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry,Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.Strong background in Chemistry and Analytical testing is required.Knowledge:Understanding and application of principles, concepts, theories, and standards of GMP QC analytical laboratories.Deepens technical knowledge through exposure and continuous learningKnowledge of related regulatory/industry considerations, compliance issues and/or scientific discoveryProblem Solving:Applies analytical skills to evaluate and interpret complex situations/ problems using multiple sources of informationQualitative informationQuantitative researchTrend dataAnticipates and prevents potential problemsPackageContract roleHourly Rate €25 - €32 per hourMinimum 12 month contractContactKaren McHugh is the consultant managing this position.If you are a QC Analyst interested in roles based in Dublin , you can contact Karen by e-mail at Karen@jobcontax.com Karen or phone 353 1 9696683 for a confidential chat.JobContax do not send CVs to clients without candidate permission.With over 50 years of technical recruitment experience, JobContax is the leading recruiter of QC Analysts in Dublin and Ireland.Due to the large volume of applications, JobContax may not be able to respond to every individual.taglife
