Biotech QC Analyst – Electronic Lab Notebook Systems

Job title:

Biotech QC Analyst – Electronic Lab Notebook Systems

Company:

JobContax

Job description

Biotech QC Analyst – Electronic Lab Notebook Systems – Dun Laoghaire, DublinOffice/Project Location: Dun Laoghaire, DublinEmployment Type: ContractWork Location: HybridPay: €30 – €37 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 Laoghaire, 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.The ideal candidate will have laboratory experience in biopharma and familiarity with lab software applications in particular use of an ELN(electronic notebook) and validation testing of GxP software.The candidate will execute deliverables for a project to implement new, fully Electronic Lab Notebook (ELN) system.This is a non-laboratory testing position.This position will be responsible for performing activities towards the design, configuration, and validation of the new ELN system, recreation and/or migration of required master data, and involvement in deployment of production instances at the site(s).This position will be expected to adhere to established procedures (Standard Operating Procedure, Work Instruction) for safety and cGMP/CFR requirements which includes, but is not limited to, expectations of training and documentation practices.This position will work in a team environment, collaborating with various colleagues to ensure project commitments are met.They will report status/updates of key responsibilities and escalate any issues through the project management team.Participate in process engineering activitiesFacilitate the development of new business SOPs, Forms, Manuals, etc. using new processes/workflowsParticipate in system requirement, software configuration, and design activitiesReceive and/or verify master data for the site(s)Coordinate ELN Template development and review with site SMEsSupport the development and review of Operational QualificationsExecute User Acceptance Testing & Data Migration VerificationReview and provide input on training materialsSupport training material development by providing inputs and reviewsSupport site Instrument Qualification activities such as planning and executionRequirementsBachelor’s degree and 3 years of industry Quality Control or Quality experienceGxP experience, specifically practices and requirements in the testing of biopharmaceuticals.Experience in development and validation testing of software used in a GMP environment.Experience and knowledge in using electronic lab notebook systems (Biovia OneLab, ThermoFisher Sample Manager, LabWare, Benchling, etc.).Experience in the use of other industry systems such as Veeva & Empower.Experience in testing or with processes involving analytical methods.Proficient in Microsoft Office (i.e., Outlook, Word, Excel, PowerPoint).Excellent problem-solving capabilities and attention to detail.Experience of collaboration within and across functional areas.Excellent written and verbal communication skills.PackageContract role – Hourly rate €30 – €37 per hourMinimum 12 month contract with the possibility of an extension.Onsite expectations: Hybrid role up to 3 days per week on siteContactKaren McHugh is the consultant managing this position.If you are an Biotech QC Analyst interested in roles based in Dublin , you can contact Karen by e-mail at karen@jobcontax.com Karen or phone 353 1 7979720 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 QC Analysts in Dublin and Ireland.Due to the large volume of applications, JobContax may not be able to respond to every individual.taglife

Expected salary

€30 – 37 per hour

Location

Dublin

Job date

Wed, 02 Apr 2025 22:03:11 GMT

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