Contract QA Operations Specialist: Batch Review

Regeneron Pharmaceuticals; Limerick; On-site; EUR 55,000 - 75,000; Full time

Job summary

Regeneron Pharmaceuticals in Raheen, Limerick, seeks a Temp QA Specialist to join the QA Operations Batch Review team, contributing to quality oversight in manufacturing and supporting rapid, compliant production.

The role involves reviewing manufacturing records, triaging non-conformances, leading investigations, and partnering with cross-functional teams to resolve issues, while mentoring others in QA processes.

Qualifications

• Experience with QA oversight in pharmaceutical manufacturing and real-time decision making
• Strong documentation and record-keeping for investigations and change controls
• Knowledge of GMP/Regulatory expectations and QA procedures

Responsibilities

• Provide QA oversight and primary quality representation in production areas
• Review and approve manufacturing documentation, area clearances, and changes
• Lead investigations, CAPAs, deviations and root-cause analysis with cross-functional teams
• Mentor and train staff on QA processes, policies, and standards
• Support product disposition, release activities and trend analysis
• Identify opportunities for continuous improvement in quality and efficiency

Skills

Quality assurance

Cross-functional collaboration

Regulatory knowledge

Documentation

Education

BS/BA in scientific discipline or related field

MS in scientific discipline or related field

Job description

Regeneron Pharmaceuticals in Raheen, Limerick, seeks a Temp QA Specialist to join the QA Operations Batch Review team, contributing to quality oversight in manufacturing and supporting rapid, compliant production.

The role involves reviewing manufacturing records, triaging non-conformances, leading investigations, and partnering with cross-functional teams to resolve issues, while mentoring others in QA processes.