Microbiology QC Testing , Manufacturing Support - Dun Laoghaire, DublinOffice/Project Location: Dun Laoghaire, DublinEmployment Type: ContractWork Location: On SitePay: €25 - €35 per hourExperience: 3+ 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.Under minimal supervision, successful candidate would be responsible for one or more of the following activities in QC including microbiological testing, method transfers, sample and data management and equipment maintenance.This role is for an experienced and technically strong associate who will spend 90% of their work day performing testing.The successful candidate would contribute to team by ensuring the quality of the tasks/services provided by self and contribute to the completion of milestones associated with specific projects or activities within team.This role will support manufacturing operations, as such some extended hours, shift and weekend work maybe necessary as required.Endotoxin testing of water, in-process and drug product release samplesBioburden testing of water & in-process drug product samplesSterility testingWater samplingLab Support duties such as Biological Indicator testing, Growth Promotion, Media Preparation, Identifications and Autoclave.Writing technical reportsPerform analytical testing as a main priority with efficiency and accuracyWith a high degree of technical flexibility, work across diverse areas within the labPlan and perform multiple routine/ non-routine methods and procedures with a large variety of assays.Report, evaluate, archive, trend and approve analytical data.Troubleshoot, solve problems and communicate with stakeholders.Initiate and/or implement changes in controlled documents.Participate in audits, initiatives, and projects that may be departmental or organizational in scope.Write protocols and perform assay validation.Introduce new techniques to the lab, including method transfers, reports, validations and protocols.Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.Review and Approve lab resultsMay participate in lab investigations.May provide technical guidance.May train others.May contribute to regulatory filings.May represent the department/organization on various teamsMay interact with outside resourcesRequirementsBachelors degree in a science disciplineBiopharmaceutical QC experience in a microbiology labExperience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical productsExperience working in endotoxin, bioburden or sterility testingProficient in GMP systems such as LIMS Labware & LMESExperience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), Rapid Micro techniques, Microbial Identification, Media prep, Water Sampling.Understanding and application of principles, concepts, theories and standards of GMP QC microbiology laboratories. Deepens technical knowledge through exposure and continuous learningKnowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery SkillsTake initiative to identify and drive improvementsExcellent verbal and written communication skillsStrong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)Presentation skillsEscalate issues professionally and on a timely basisDecision Making skillsTeamwork and Coaching othersNegotiation and Influence skillsProblem solving skillsApplies research, information gathering, analytical, and interpretation skills to problems of diverse scopeEnsures compliance within regulatory environmentDevelops solutions to technical problems of moderate complexityScreens, categorizes, evaluates, reconciles, reports, and resolves data integrity issuesInterprets generally defined practices and methodsTechnically strong background in microbiology and aseptic manufacturingExperience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantageFlexibility – the role often encounters changing priorities (also required to work weekend on call – Rota system)Demonstrated ability to work independently and deliver right first time resultsWorks under minimal direction, Recognizes and escalates problemsWork 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 assignments.PackageContract role - Hourly rate €25 - €35 per hourMinimum 12 month contractLocation: Fully onsite, with hours from 08:00 to 17:00.On-Call: You'll be on rotation every 8 weeks.If a bioburner sample pops up, you'll need to step in and handle the testing.ContactKaren McHugh is the consultant managing this position.If you are a Microbiology QC Testing 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 Microbiology QC Testing in Dublin and Ireland.Due to the large volume of applications, JobContax may not be able to respond to every individualstaglife
