Biotech QC Analyst - Electronic Lab Notebook Systems - Dun Laoghaire, Dublin
Office/Project Location: Dun Laoghaire, Dublin
Employment Type: Contract
Work Location: Hybrid
Pay: €30 - €37 per hour
Experience: 3 + years
Visa: EU passport or Stamp 4 visa required
Our 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 activities
Facilitate the development of new business SOPs, Forms, Manuals, etc. using new processes/workflows
Participate in system requirement, software configuration, and design activities
Receive and/or verify master data for the site(s)
Coordinate ELN Template development and review with site SMEs
Support the development and review of Operational Qualifications
Execute User Acceptance Testing & Data Migration Verification
Review and provide input on training materials
Support training material development by providing inputs and reviews
Support site Instrument Qualification activities such as planning and execution
Requirements
Bachelor's degree and 3 years of industry Quality Control or Quality experience
GxP 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.
Package
Contract role - Hourly rate €30 - €37 per hour
Minimum 12 month contract with the possibility of an extension.
Onsite expectations: Hybrid role up to 3 days per week on site