Quality Control Analyst

Gefunden in: beBee S AT - vor 1 Monat

Bern, Österreich Hays Vollzeit
  • Responsible for maintaining a safe working environment 
  • Active participation in safety investigations and improvements
  • Stay current with cGMP training as required to maintain compliance with quality and regulatory commitments
  • Follow documentation and data integrity requirements associated with generation, review and reporting of cGMP activities
  • Provide independent verification and review and/or approval of data and reports generated to support the development, validation, and analytical lifecycle management of gene therapy methods
  • Provides expertise in investigation of laboratory and manufacturing deviations, atypical results and method performance issues as a subject matter expert and leads the execution of appropriate testing and interpretation of analytical results
  • Prepare, review and update standard operating procedures, test procedures, protocols and associated documentation in the performance of development, validation, and analytical lifecycle management studies and investigations
  • Develop, author and/or review standard operating procedures required to for internal and external cGMP QC activities
  • Responsible for ensuring that all activities performed and led are undertaken in compliance with associated SOPs, procedures, test plans and protocols as appropriate
  • Manages the development of project plans including estimated cost, time and resources for the identified work activities. Responsible for the oversight and management of moderate to large, complex projects that may be require global project management
    • Education BS/BA in Engineering, Physical, or Biological Science or other appropriate technical field. Relevant post-graduate qualification (Masters or Doctoral degree) is preferred or equivalent learning through extensive industry experience 
    • Well-founded experience in cGMP Quality Control and well-founded experience in method development for assessment of gene therapy products
    • Extensive experience in method development and validation for testing of AAV or similar products for gene therapy suitable for cGMP application
    • Experience in cGMP testing, with experience in the QC testing of gene therapy products advantageous
    • Proven written and verbal communication skills 
    • Extensive experience in all aspects of analytical method lifecycle management
    • Strong, demonstrated problem solving skills and experience in practical application of concepts into cGMP environments
    • Proven technical and scientific knowledge and experience aligned with CSL QC
    • Demonstrated experience in managing complex project deliverables
    • Experience in project management and matrix leadership advantageous
      • Pleasant working atmosphere
      • Interesting and varied activities
      • Future-proof industry
      • Support from Hays throughout the entire recruitment process With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.