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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Quality Control Bioassay Specialist


Reference:RK26218 Location: Republic of Ireland
Qualification:DegreeExperience:4-5 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QC Analyst

Quality Control Bioassay Specialist
Onsite
RK26218
Contract 11 months
Louth


We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


This role will support key bioassay laboratory start-up activities and provide technical expertise to support quality control testing, method troubleshooting, method establishment, investigations, and capability building across the team.


Key Responsibilities:

  • Provide technical support for Quality Control testing activities, including:
- Method execution troubleshooting

- Method establishment

- Input into investigations

- Capability building in Biochemistry, Cell Biology, and Analytical methods

  • Support the performance and optimisation of advanced assays requiring strong analytical and scientific understanding.
  • Review, evaluate, and approve analytical testing data.
  • Complete special project and protocol testing in a timely manner under direction of Project Leads and/or Area Leads.
  • Use laboratory instrumentation and Global LIMS or other computerized systems to collect, record, and approve test data/results.
  • Collaborate with laboratory and cross-functional teams to improve efficiency, solve problems, generate cost savings, and support new product introductions.
  • Operate with minimal supervision and demonstrate sound judgment and accountability.
  • Maintain the laboratory in a GMP-compliant state in accordance with EHS and 5S requirements.
  • Prepare and update SOPs as required.
  • Apply Lean principles, including 5S, simplification, and standard work, in daily activities.
  • Ensure training requirements are current and support the training of others as needed.
  • Coach and develop team members to build technical capability and support a high-performance culture.
  • Support regulatory submissions, inspection readiness, health authority inspections, and responses to inspection observations.
  • Contribute to audit readiness, laboratory equipment qualification, and analytical method transfer, verification, and validation.
  • Support site metrics and KPI achievement, implementing countermeasures where required.
  • Maintain data integrity and ensure compliance with company SOPs, specifications, FDA, cGMP, and other applicable regulations.
  • Participate actively in inspections, GEMBAs, and Go-Sees.


Education and Experience:
  • Degree in Science, Quality, or a related technical discipline.
  • Minimum of 5 years’ experience in the biotechnology and/or pharmaceutical industry, preferably both.
  • Strong technical knowledge of cell-based and cell biology methods, such as qPCR, as well as analytical methodologies.
  • Strong understanding of GMP, ICH, USP, and global compendia regulations and guidance, particularly relating to analytical method development and validation.
  • Experience with continuous improvement tools such as DMAIC, Lean QA, and 5S.


If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.