Job Description
Drive Quality Through Technical Expertise
Quality Control Bioassay Specialist
Join a highly regulated pharmaceutical environment where your technical expertise will support Quality Control, analytical methods, GMP compliance, and laboratory capability.
We're looking for an experienced QC professional who can troubleshoot analytical methods, support investigations, review laboratory data, and contribute to continuous improvement.
What you'll achieve (and why it matters)
- Provide technical support across QC laboratory and analytical activities.
- Support analytical method troubleshooting, establishment, transfer, verification, and validation.
- Apply technical expertise across bioassay, cell biology, biochemistry, and analytical methodologies.
- Review and approve analytical data while maintaining GMP and data integrity requirements.
- Support quality investigations, problem-solving, and corrective actions.
- Use laboratory instrumentation and LIMS to record, review, and manage analytical data.
- Prepare and update SOPs and support laboratory compliance.
- Support equipment qualification, audits, regulatory inspections, and inspection readiness.
- Contribute to Lean, 5S, and continuous improvement initiatives.
- Support laboratory capability development and coach colleagues where required.
Your edge (desired, not required)
- Bachelor's degree in Science, Quality, Biotechnology, or a related discipline.
- 5+ years' pharmaceutical and/or biotechnology industry experience.
- Experience in a GMP-regulated QC or analytical laboratory.
- Strong knowledge of analytical methods, ideally including cell-based methods or qPCR.
- Understanding of GMP/cGMP, ICH, USP, FDA requirements, and global compendia.
- Experience with method establishment, troubleshooting, validation, verification, or transfer.
- Experience with investigations, analytical data review, and LIMS.
- Exposure to audits, regulatory inspections, or equipment qualification.
- Lean, 5S, DMAIC, or Lean Six Sigma experience is advantageous.
- Strong analytical, communication, organisational, and problem-solving skills.
- Ability to work fully onsite in Dundalk, Co. Louth.
Why this role matters
You'll play a key role in maintaining the quality and compliance of pharmaceutical operations while helping solve technical challenges and strengthen laboratory capability.
This is not a routine QC testing position. It offers the opportunity to apply your scientific and technical expertise across analytical methods, investigations, GMP, and continuous improvement.
The next step for you
If this opportunity is of interest, please send your CV to danielle.johnson@nextgeneration.ie or reach out to discuss the role further.
All applications are treated in the strictest confidence.
Next Generation Recruitment specialises in Supply Chain, Procurement, Engineering, Quality, Technical, Scientific, Manufacturing, and Operations recruitment across permanent, contract, and temporary positions.
Your personal data will never be shared outside our organisation without your prior written consent.