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MIMiltenyi Biotec

Functional head of quality control(m/w/x)

Bergisch Gladbach
Full-timeOn-siteSenior

Quality control for cell-based ATMPs, including material/product checks and test procedure validation. Several years of GMP experience and §12 AMWHV compliance required. International teams, corporate sports, and health provision.

Requirements

  • Completed science studies
  • Several years of professional experience in quality control of cell-based ATMPs
  • Extensive experience under GMP
  • Worked as head of quality control in accordance with §12 AMWHV or fulfill requirements to complete training
  • Ready to take on responsibility for ATMPs
  • Strong understanding of analytical methods in quality control of cell-based ATMPs
  • Experience with flow cytometry
  • Experience with qPCR analyses
  • Experience with endotoxin tests
  • Experience with microbiological tests
  • Structured, prudent, and solution-oriented manner
  • High level of quality and responsibility
  • Ability to motivate team to achieve top performance
  • Willingness to work early, late, or evening if necessary
  • Fluent English skills, spoken and written
  • Desired German skills in speaking, reading, and writing

Tasks

  • Ensure quality checks of materials and products
  • Release or block products according to specifications
  • Perform head of quality control duties
  • Validate test procedures in operational teams
  • Conduct and document necessary tests
  • Qualify equipment and validate computer systems
  • Participate in process improvement and efficiency
  • Create GMP-relevant SOPs
  • Maintain high quality standards
  • Participate in self-inspections and audits
  • Process open activities and anomalies

Work Experience

  • approx. 4 - 6 years

Education

  • Vocational certificationOR
  • Bachelor's degree

Languages

  • EnglishFluent
  • GermanBasic

Tools & Technologies

  • flow cytometry
  • qPCR analyses
  • endotoxin tests
  • microbiological tests

Benefits

Informal Culture

  • International teams
  • Cross-border intercultural communication
  • Room for creativity

Healthcare & Fitness

  • Corporate sports activities
  • Health provision

Learning & Development

  • In-house Training Academy
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Miltenyi Biotec and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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