Quality Control Bioassay Specialist

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:

• 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.

• 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.