Temp QA Specialist: QA Operations & Compliance

Regeneron; Limerick; On-site; EUR 45,000 - 65,000; Full time

Job summary

Regeneron in Raheen, Limerick is seeking a Temp QA Specialist to join the QA Operations Batch Review team. This role offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

You will provide QA oversight across manufacturing operations, collaborate with cross-functional teams, review documentation, participate in investigations, and drive continuous improvement while ensuring compliance with regulatory expectations.

Qualifications

• Assoc Specialist with BS/BA in a scientific discipline or related field, or equivalent combination of education and experience.
• Specialist with BS/BA in scientific discipline or related field and 3+ years pharma experience.
• Sr Specialist with 5+ years pharma experience or MS with 4+ years.

Responsibilities

• QA oversight for manufacturing operations and primary quality representative in production areas.
• Facilitate issue resolution with cross-functional teams, ensuring proper documentation and quality oversight.
• Assess and triage potential non-conformances in real time with complete information for investigations.
• Review and approve manufacturing documentation including area clearances, incursions, and changeovers.
• Support investigations, CAPAs, and change controls; provide QA guidance per policies and regulatory expectations.
• Mentor and train staff on QA processes and standards; contribute to continuous improvement.

Skills

QA oversight

Cross-functional collaboration

Documentation

Investigations

CAPA management

Root cause analysis

Training and coaching

Quality systems

Education

Assoc Specialist - BS/BA in scientific discipline or related field or equivalent combination of education and experience

Specialist - BS/BA in scientific discipline or related field with min 3 years of relevant work experience in pharmaceutical or related industry or equivalent combination of education and experience

Sr Specialist - BS/BA in scientific discipline or related field with 5+ years or MS 4+ years of relevant work experience in pharmaceutical or related industry or equivalent combination of education and experience

Job description

Regeneron in Raheen, Limerick is seeking a Temp QA Specialist to join the QA Operations Batch Review team. This role offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

You will provide QA oversight across manufacturing operations, collaborate with cross-functional teams, review documentation, participate in investigations, and drive continuous improvement while ensuring compliance with regulatory expectations.