QC Bioassay Specialist

Orion Group Life Sciences are currently recruiting a Quality Control Bioassay Specialist on behalf of our Multinational Biopharmaceutical Client based in Dundalk on an initial 11-Month contract with potential to extend.
 
About the Role
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 laboratories as a hub for specialised analytical testing while ensuring compliance with cGMP and corporate regulations. This is a high-impact role within the Quality organisation, 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 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 the direction of Project Leads and/or Area Leads.
• Use laboratory instrumentation and LIMS or other computerised 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 while demonstrating sound judgement 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 maintained and support the training of colleagues where required.
• 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 corrective actions where required.
• Maintain data integrity and ensure compliance with company SOPs, specifications, FDA, cGMP, and other applicable regulatory requirements.
• Participate actively in inspections, GEMBAs, and continuous improvement activities.
• 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 data-driven decision making to improve laboratory performance.
• Perform other duties as required.

 
What You'll Bring

• Degree in Science, Quality, or a related technical discipline.
• Minimum of 5 years' experience within the biotechnology and/or pharmaceutical industry.
• Strong technical knowledge of cell-based assays, cell biology techniques (including qPCR), and analytical methodologies.
• Excellent understanding of GMP, ICH, USP, and global compendia requirements relating to analytical method development and validation.
• Experience with continuous improvement methodologies such as Lean, DMAIC, and 5S.
• Strong troubleshooting and problem-solving skills.
• Excellent written and verbal communication skills.
• Strong organisational and time management skills with the ability to prioritise effectively.
• Ability to work independently while also contributing as part of a collaborative team.
• Proactive, flexible, and self-motivated approach with the ability to perform well in a fast-paced environment.
• Lean Six Sigma experience would be advantageous.

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Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.