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QC Document Controller - Job Opportunity at WuXi Biologics

Dundalk, Ireland
Full-time
Mid-level
Posted: January 28, 2025
On-site
EUR 45,000 - 60,000 annually based on Ireland market rates for similar QC roles

Benefits

Global career development opportunities within leading biopharma CDMO
Professional growth in GMP environment
Collaborative work culture with international exposure
Opportunity to work on cutting-edge biologics projects

Key Responsibilities

Lead GMP documentation management for QC department including paper-based and electronic systems
Oversee quality document implementation and distribution across QC operations
Manage document lifecycle including issuance, review, and archival processes
Serve as QC subject matter expert for MasterControl system
Support regulatory audit preparation and documentation requirements

Requirements

Education

Diploma / degree qualification is desirable

Experience

5+ years' experience working in a fast-paced environment

Required Skills

Excellent computer skills MS Office (WORD, EXCEL, PowerPoint) Excellent organizational skills Communication and interpersonal skills Problem solving and troubleshooting GMP knowledge Documentation management Quality systems expertise
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Sauge AI Market Intelligence

Industry Trends

Increasing regulatory scrutiny in biologics manufacturing is driving higher demand for documentation expertise Digital transformation of quality systems creating need for hybrid paper-electronic document management skills Growing biologics CDMO sector requires experienced quality professionals to support rapid scaling

Role Significance

Typically part of 5-10 person QC documentation team in large biologics facility
Mid-level role with significant operational responsibility and cross-functional impact

Key Projects

Quality management system implementation and optimization Regulatory inspection preparation Documentation process standardization Electronic quality system implementation

Success Factors

Strong attention to detail and systematic approach to documentation management Ability to work effectively in fast-paced GMP environment Understanding of regulatory requirements and quality systems Strong communication skills for cross-functional collaboration

Market Demand

High demand due to biologics industry growth and increasing focus on documentation quality

Important Skills

Critical Skills

GMP documentation expertise - essential for maintaining regulatory compliance Quality system knowledge - crucial for effective document control Communication skills - vital for cross-functional coordination

Beneficial Skills

Electronic quality system experience Project management capabilities Industry-specific software knowledge

Unique Aspects

Opportunity to work in rapidly expanding biologics CDMO sector
Exposure to diverse range of biologics projects and global clients
Role in establishing quality systems for new manufacturing facility

Career Growth

2-4 years in role before advancement, depending on performance and organizational growth

Potential Next Roles

QC Documentation Manager Quality Systems Manager GMP Compliance Manager Quality Operations Lead

Company Overview

WuXi Biologics

WuXi Biologics is a leading global CDMO specializing in biologics development and manufacturing, serving over 600 clients worldwide

Top 3 global biologics CDMO with strong market position and continued growth trajectory
Strategic European manufacturing hub in Ireland supporting global operations
Fast-paced, quality-focused environment with emphasis on innovation and global collaboration
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  • Salary estimates and market demand analysis
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  • Critical success factors and key skills
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