Position: Senior Specialist QC - Quality Systems (Investigations)Location: Ireland, Dublin (Hybrid)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
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)
Why Join Us?
Join a growing QC Quality Systems team during a period of significant site expansion
Exposure to new facilities, technologies, and global projects
Opportunity to shape QC processes and quality systems
Collaborative team environment with strong leadership support
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