Quality Control Bioassay Specialist

Next Generation; Leinster; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Onsite role in Dundalk

Job summary

Next Generation in Ireland is seeking a Quality Control Bioassay Specialist to support GMP-compliant QC laboratory activities, analytical method troubleshooting, data review, and continuous improvement.

You will work onsite in Dundalk, applying bioassay, cell biology, and biochemistry expertise, maintain data integrity in LIMS, and contribute to method transfers and investigations in a regulated environment.

Qualifications

• Bachelor’s degree in Science, Quality, Biotechnology or related discipline.
• 5+ years of pharmaceutical/biotech experience.
• Experience in GMP-regulated QC or analytical lab.
• Strong knowledge of analytical methods; qPCR a plus.
• Understanding of GMP/cGMP, ICH, USP, FDA requirements.
• Experience with method establishment, troubleshooting, validation, transfer.
• Experience with investigations, data review, and LIMS.
• Exposure to audits/regulatory inspections or equipment qualification.
• Lean/Six Sigma experience advantageous.

Responsibilities

• Provide technical support across QC laboratory and analytical activities.
• Troubleshoot analytical methods, establish/transfer/validate methods.
• Review analytical data maintaining GMP and data integrity.
• Support investigations, problem-solving and CAPAs.
• Coach colleagues and contribute to capability development.

Skills

QC laboratory

GMP compliance

LIMS

SOPs

analytical methods

investigations

bioassay

problem solving

Education

Bachelor's degree in Science/Quality/Biotechnology

Tools

LIMS

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

All applications are treated in the strictest confidence.

Your personal data will never be shared outside our organisation without your prior written consent.