Quality Control Bioassay Specialist

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Dundalk
• State/Province Louth
• Country Ireland

Job Description

We are seeking a highly skilled and motivated Quality Control Bioassay Specialist to join our Quality Control team on a fixed-term contract basis. This critical 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. The successful candidate will play an important role in helping establish the laboratory as a hub for specialised analytical testing while ensuring compliance with cGMP and corporate regulations. This is a high impact role within the Quality organization, offering the opportunity to contribute directly to operational excellence and patient impact.

Key Responsibilities

• Provide technical support for Quality Control testing activities, including method execution and troubleshooting.
• Build capability 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 projects 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.
• Promote a strong safety culture by identifying hazards, conducting risk assessments, and supporting continuous improvement in EHS practices.
• Act as a visible leader in safety, quality, and continuous improvement initiatives.
• Encourage innovation, problem solving, and real time data driven decision making to improve the value stream.
• Perform other tasks as required.

What You'll Bring

• 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.