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QA Engineer I in Naarden, Nederland

Thermo Fisher Scientific

Naarden, Nederland

Quality Assurance Engineer I at Thermo Fisher Scientific's Naarden site, responsible for maintaining and improving the Quality Management System, reviewing batch records, managing deviations in a GMP environment, and supporting customer projects for affinity resin manufacturing.

Responsibilities

  • Maintain and continuously improve the Quality Management System
  • Review batch records, generate Certificates of Analysis, and release products
  • Register and review root cause investigations of deviations and complaints in TrackWise
  • Support customer problem-solving initiatives to improve efficiencies and satisfaction
  • Address customer inquiries regarding product specifications and compliance

Requirements

  • HBO degree in Chemistry, Biology, Biotechnology, Engineering, or related field
  • 3+ years Quality Assurance experience or Master's degree in relevant discipline
  • Experience with ISO 9001 or GMP quality management systems
  • Proficiency with Document Management Systems and TrackWise software
  • English language competency at HBO/scientific level
  • Strong knowledge of quality standards including cGLP, GMP, and ISO 9001
  • Problem-solving and independent work capability with cross-functional collaboration skills
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