Biotech NPI Testing QC Analyst

Job title:

Biotech NPI Testing QC Analyst

Company:

JobContax

Job description

Biotech NPI Testing QC Analyst – Dun Laoghaire, DublinOffice/Project Location: Dun Laoghaire, DublinEmployment Type: ContractWork Location: On SitePay: €30 – €35 per hourExperience: 2+ yearsVisa: EU passport or Stamp 4 visa requiredOur 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.QC 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.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 resourcesRequirementsBachelor’s degree in a science discipline.2-3 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.Strong background in Chemistry and Analytical testing is required.Lab experienceExperience in protein such as service, sizes, exclusion, reserve phase CX or different methods.HPLC backgroundAttention to detail and organisedExperience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.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 discoveryApplies analytical skills to evaluate and interpret complex situations/ problems using multiple sources of informationAnticipates and prevents potential problemsTake initiative to identify and drive improvementsCommunication skills (verbal and written) at all levelsStrong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)Presentation skillsEscalate issues professionally and on a timely basisDecision makingTeamwork and Coaching othersTeamwork and Coaching othersAuditing documentation and operation processDemonstrated ability to work independently and deliver right first-time resultsWorks under minimal directionWork is guided by objectives of the department or assignmentFollows proceduresRefers to technical standards, principles, theories, and precedents as neededMay set project timeframes and priorities based on project objectives and ongoing assignmentsRecognizes and escalates problemsWorking knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleaguesAuditing documentation and operation processDemonstrated ability to interact with regulatory agenciesPackageContract role – Hourly rate €30 – €35 per hourMinimum 12 month contractOnsite expectations: There is hands-on testing five days a week.ContactKaren McHugh is the consultant managing this position.If you are a Biotech NPI Testing 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 Biotech NPI Testing QC Analysts in Dublin and Ireland.Due to the large volume of applications, JobContax may not be able to respond to every individualstaglife

Expected salary

€30 – 35 per hour

Location

Dublin

Job date

Wed, 02 Jul 2025 22:39:31 GMT

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