GMP Documentation Specialist | GMP-Spezialist in der Dokumentation (m/w/d)

PS Direkt GmbH Co. KG

Köln, Nordrhein-Westfalen, Deutschland
Published May 7, 2026
Full-time
Permanent

Job Summary

This role involves working within a biotechnology company near Cologne, focusing on the operational support of cell therapy manufacturing. Your primary responsibility is to ensure the integrity and compliance of production documentation. You will review and approve batch records according to GMP guidelines, coordinate with quality control and quality assurance departments, and manage the documentation lifecycle. Additionally, you will be responsible for creating and updating Standard Operating Procedures (SOPs) and conducting scheduled equipment inspections. This position is ideal for a detail-oriented professional with a background in technical laboratory work who enjoys maintaining rigorous documentation standards. The role offers a stable, permanent position in an international environment dedicated to cancer research, providing the opportunity to contribute to life-saving therapeutic processes while working with modern technology and flexible scheduling.

Required Skills

Education

Completed vocational training as a Biological Technical Assistant (BTA), Chemical Technical Assistant (CTA), Biology Laboratory Technician, Chemistry Laboratory Technician, or a comparable qualification.

Experience

  • Professional experience as a Biological Technical Assistant, Chemical Technical Assistant, or Biology Laboratory Technician
  • Experience working with batch records under GMP conditions is preferred

Languages

German (Basic)English (Basic)

Additional

  • Work permit for Germany required; role is based in Cologne; full-time, permanent contract.