Job Description

Position: Senior Specialist QC – Quality Systems (Investigations)
Location: Ireland, Dublin
Contract Duration: 12 Months

Ready to take the lead in shaping the future of QC Quality Systems? Join us as a Senior Specialist QC – Quality Systems (Investigations) and drive impactful laboratory investigations, CAPAs, and quality initiatives in a rapidly growing, cutting-edge GMP environment.

We are expanding our QC Quality Systems team and are seeking a Senior Specialist QC- Quality Systems (Investigations) to lead and support a growing portfolio of QC investigations and change control activities.

Key Responsibilities:

• Lead and manage QC investigations, including OOS results, deviations, non-conformances, and laboratory investigations
  
  
• Perform and document Root Cause Analysis (RCA) and drive problem-solving initiatives
  
  
• Own and support CAPAs, including implementation, risk-based assessments, tracking, and effectiveness reviews
  
  
• Manage QC Change Control activities for new analytical methods, instruments, and QC systems
  
  
• Participate in global investigations as required and present outcomes to senior stakeholders
  
  
• Support operational excellence initiatives and continuous improvement projects
  
  
• Contribute to innovation in QC, including adoption of digital solutions and AI
  
  
• Support audits and inspections, providing documentation and read-outs as required
  
  

Required Experience & Skills

• Minimum 3 years’ experience in a GMP-regulated environment
  
  
• At least 1 year hands-on experience in QC investigations
  
  
• Minimum B.Sc. in Biochemistry or a related discipline
  
• Strong understanding of investigation processes, RCA methodologies, CAPAs, and GMP documentation
  
  
• Experience working with or supporting CAPAs
  
  
• Strong communication skills and confidence engaging with senior stakeholders

Desirable:

• QC Change Control experience
  
  
• Background in continuous improvement or operational excellence initiatives
  
  
• QC laboratory experience (manufacturing investigations also considered)
  
  
• Knowledge of biologics QC testing (separations, bioanalytical, microbiology, raw materials, stability testing)