Senior Laboratory Researcher

5 days ago

Cork, Cork, Ireland Cpl Healthcare Full time
Role Overview

The successful candidate will be a highly skilled Laboratory Analyst responsible for working on analytical project requirements through analytical laboratory transfer and commercialization in a new manufacturing facility. Key responsibilities include test method validation, equipment validation, training and development of laboratory processes and SOPs.

Duties:
  1. Ensuring adherence to all company EHS guidelines and procedures with proactive involvement in laboratory safety initiatives.
  2. Development and validation of laboratory test methods to ensure compliance with relevant regulatory standards.
  3. Collaboration on the preparation and execution of the Project Validation Master Plan ensuring it is compliant with quality standards.
  4. Preparation of validation and other related documentation, including protocols, SOPs, management procedures, etc.
  5. Execution of protocols and compilation of reports generated from validation activities identified in the validation master plan.
  6. Training on laboratory procedures and development of onboarding plans for future analysts within the area.
  7. Leadership in analytical method development/troubleshooting for the project laboratory groups.
  8. Review of laboratory data ensuring accuracy for all relevant product within the project scope.
  9. Validation of laboratory equipment, software, spreadsheets and methods.
  10. Performance of validation, release, and non-routine testing as required.
  11. Support site commercialization readiness.
  12. Maintenance of lab fitness for audits.
  13. Compliance of the laboratory projects to all applicable quality, regulatory and Pharmacopeia requirements.
  14. Work within Filtration 2.0 laboratory calibration and preventative maintenance system.
  15. Technical support to all F2.0 functional groups as required.
  16. Management of laboratory project timelines and communication with the laboratory supervisor.
  17. Ensuring protocols, reports, test methods, SOPs and all other relevant documentation are drafted and approved prior to use.
  18. Completion of laboratory investigations in a timely manner and in accordance with site procedures.
  19. Support of laboratory colleagues for laboratory investigations and utilization of standard root cause analysis tools.
  20. Participation in risk mitigation initiatives such as FEMAs and risk assessments.
  21. Identification and participation in Continuous Improvement initiatives.
  22. Control and issue of laboratory documentation. Archive of laboratory data, logbooks and samples in accordance with procedures.
  23. Ordering, receiving and control of laboratory chemicals, reagents and consumables.
  24. Investigation of quality and safety issues using root cause analysis methodology and implementation of robust corrective and preventative actions.

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