(Senior) Specialist Quality Control | (Senior) Specialist Qualitätskontrolle (m/w/d)

QIAGEN GmbH

Hilden, Nordrhein-Westfalen, Deutschland
Published Aug 7, 2025
Full-time
Permanent

Job Summary

This role at QIAGEN in Hilden (near Düsseldorf) focuses on ensuring the quality and integrity of laboratory systems and processes. The successful candidate will be responsible for planning, executing, documenting, and verifying qualification and validation activities, as well as managing change processes. This involves close collaboration with IT, Quality Assurance, and other departments. Key responsibilities include supporting the introduction of new technologies in a regulated lab environment, installing and validating lab equipment, and managing IT/OT infrastructure to ensure data integrity and compliance with regulatory requirements like GMP, 21 CFR Part 11, and IVDR. This position is ideal for a professional with a scientific or technical background who is passionate about making a tangible impact on scientific research and healthcare.

Required Skills

Education

Bachelor's or Master's degree in a scientific or technical field

Experience

  • Several years of professional experience with a Bachelor's degree, or initial demonstrable professional experience with a Master's degree
  • Experience in planning, execution, and GMP-compliant documentation of qualifications (DQ/IQ/OQ/PQ) and validations, including change management
  • Knowledge in creating requirement profiles, specifications, risk analyses, and traceability matrices in both laboratory and IT environments
  • Demonstrable knowledge of regulatory requirements (e.g., GMP, 21 CFR Part 11 / EU GMP Annex 11, IVDR, ISO 13485)

Languages

German (Fluent)English (Fluent)

Additional

  • Not specified