Biotech GMP Document Controller – Audits & Compliance

LSC, Life Science Consultants

Limerick

On-site

EUR 42,000 - 62,000

Full time

9 hours ago
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Job summary

LSC is seeking a detail-oriented Document Controller to join its biotech-focused team in Ireland. The role centers on controlling electronic documentation and maintaining GMP-compliant records to support a cutting-edge biologics manufacturing site.

The candidate will manage document workflows, assist with audits, and collaborate across functions to ensure accurate, accessible records. A contract opportunity is available with a focus on quality systems and operational support.

Qualifications

  • 3+ years of document control experience in a regulated environment.
  • Experience maintaining electronic document management systems and GMP records.
  • Familiarity with audit support and change control processes.

Responsibilities

  • Maintain and update documents within the Electronic Management System, ensuring accuracy and compliance.
  • Manage workflows from initiation to approval, including metadata assignment and document review.
  • Support site inspections and internal audits by providing accessible and well-organized records.
  • Facilitate documentation of revisions, change control, and GMP records retention.
  • Collaborate with cross-functional teams to review, update, and create documentation.
  • Provide training and support to personnel on document control processes.
  • Assist with general administrative tasks such as preparing reports and organizing review meetings.

Skills

Organizational skills
Time management
Document management systems
GMP knowledge
Communication skills
Adaptability

Education

High school diploma
Bachelor's degree preferred

Tools

Electronic Management System

Job description

LSC is seeking a detail-oriented Document Controller to join its biotech-focused team in Ireland. The role centers on controlling electronic documentation and maintaining GMP-compliant records to support a cutting-edge biologics manufacturing site.

The candidate will manage document workflows, assist with audits, and collaborate across functions to ensure accurate, accessible records. A contract opportunity is available with a focus on quality systems and operational support.

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