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

PS Direkt GmbH Co. KG

Köln, Nordrhein-Westfalen, Deutschland
Published Mar 13, 2026
Full-time
Permanent

Job Summary

As a GMP Documentation Specialist for a leading biotechnology company near Cologne, you will play a critical role in the operational support of cell therapy production. Your daily responsibilities involve the meticulous review and verification of Batch Records according to Good Manufacturing Practice (GMP) standards, ensuring timely release and coordination between Quality Control, Quality Assurance, and Production departments. You will be responsible for creating and updating Standard Operating Procedures (SOPs), correcting documentation errors, and performing routine equipment inspections. This position is ideal for technical assistants who enjoy administrative precision and want to contribute to meaningful cancer research. The role offers a modern international working environment with flexible working hours and a focus on social responsibility.

Required Skills

Education

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

Experience

  • Professional experience as a Biological Technical Assistant (BTA), Chemical Technical Assistant (CTA), or Biology Lab Technician
  • Practical experience working with Batch Records under GMP conditions is highly preferred
  • Experience in error handling and correction of manufacturing documentation
  • Proven ability to manage priorities and maintain process overviews in a technical environment

Languages

German (Basic)English (Basic)

Additional

  • The position is located near Cologne. Candidates must be comfortable with full-time hours and a salary range between 25,000 EUR and 30,000 EUR gross annually.