QA Specialist-(Batch Release)-Multi Level - Job Opportunity at Regeneron

Limerick, Ireland
Full-time
Mid-level
Posted: April 24, 2025
On-site
EUR 45,000-75,000 annually based on level and experience in Irish pharmaceutical market

Benefits

Comprehensive health and wellness programs
Fitness center access
Equity awards potential
Annual performance bonuses
Competitive paid time off
Professional development opportunities

Key Responsibilities

Lead batch disposition and quality compliance processes ensuring adherence to cGMPs and SOPs
Drive QC release data analysis and documentation review for critical product decisions
Manage deviation investigations and change control processes impacting product quality
Represent QA in cross-functional initiatives and external partner communications
Provide strategic quality oversight and mentorship to team members
Drive continuous improvement in quality processes and procedures

Requirements

Education

Degree or Masters in a scientific field

Experience

0-2 years for Associate Level, 3 years for Specialist, 5+ years for Sr Specialist

Required Skills

Understanding of biologics manufacturing operations Excellent organizational skills Attention to detail Written and verbal communication skills Cross-functional collaboration abilities Priority management Computer system proficiency
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Sauge AI Market Intelligence

Industry Trends

Increasing focus on biologics manufacturing quality control due to growing market demand and regulatory scrutiny Rising importance of digital quality management systems and data integrity in pharmaceutical manufacturing Growing emphasis on cross-functional collaboration in quality assurance roles

Role Significance

Typically part of a 10-15 person QA team in a larger quality organization of 50-100 professionals
Mid to senior-level position with significant impact on product quality and compliance

Key Projects

Implementation of new quality management systems Process optimization initiatives Regulatory compliance programs External partner quality alignment projects

Success Factors

Strong technical understanding of biologics manufacturing processes Excellent documentation and analytical skills Ability to navigate complex regulatory requirements Strong stakeholder management capabilities

Market Demand

High demand due to expansion of biologics manufacturing in Ireland and strict regulatory requirements

Important Skills

Critical Skills

GMP compliance expertise Quality system management Technical documentation skills Stakeholder management

Beneficial Skills

Project management Risk assessment Change management Digital quality systems expertise

Unique Aspects

Multi-level career progression opportunity within same role
Significant exposure to external partner interactions
Combination of technical and leadership responsibilities

Career Growth

2-3 years in role before advancement, faster progression possible with significant achievements

Potential Next Roles

Senior QA Specialist QA Manager Quality Systems Manager Regulatory Affairs Specialist

Company Overview

Regeneron

Leading biotechnology company specializing in breakthrough medicines for serious diseases

Top-tier biopharmaceutical company with strong market presence and innovative pipeline
Strategic manufacturing hub in Ireland serving European market
Innovation-focused environment with emphasis on scientific excellence and regulatory compliance
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