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

PS Direkt GmbH Co. KG

Köln, Nordrhein-Westfalen, Deutschland
Published Aug 27, 2025
Full-time
Permanent

Job Summary

This role involves supporting the operational aspects of cell therapeutic production by meticulously reviewing and managing batch records in compliance with GMP guidelines. The specialist will be responsible for timely release of batch records, tracking their processing status, and assisting with error correction. A key part of the job is creating and updating Standard Operating Procedures (SOPs) and conducting regular equipment checks, ensuring all documentation is accurate and up-to-date. This position is ideal for someone with a background as a biological or chemical technical assistant or laboratory technician, who thrives in a detail-oriented environment and enjoys maintaining an overview of processes. The role offers a secure position within a biotechnology company focused on cancer research, providing modern technology and flexible working hours.

Required Skills

Education

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

Experience

  • Professional experience as a Biological-technical Assistant, Chemical-technical Assistant, or Biology/Chemistry Laboratory Technician
  • Ideally, experience working with batch records under GMP conditions

Languages

German (Fluent)English (Basic)

Additional

  • Not specified