QC Associate Scientist

vor 1 Tag

Neuenburg, Schweiz Proclinical Staffing Vollzeit

Proclinical is seeking a QC Associate Scientist to join our client's team in Neuchatel, Switzerland. This role focuses on managing the life cycle of analytical assays within our Quality Control Laboratories. You will be involved in laboratory investigations, critical material qualification, and laboratory method transfers. This position requires adherence to cGMP standards and EHS requirements.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

  • Manage life cycle activities of analytical assays in QC Laboratories.
  • Conduct laboratory investigations and critical material qualifications.
  • Facilitate laboratory method transfers.
  • Author and oversee transfer protocols and reports for assays.
  • Develop qualification plans and reports for critical reagents.
  • Provide training and support for validation and qualification activities.
  • Investigate and troubleshoot laboratory issues, conducting risk assessments and root cause analysis.
  • Own laboratory investigations and CAPA processes.
  • Support compliance with industry standards and regulations.
  • Participate in daily QC activities, offering technical and statistical support.

Key Skills and Requirements:

  • Degree in analytical chemistry, biotechnology, biochemistry, or microbiology.
  • Experience in GMP laboratory activities, preferably with recombinant therapeutic products.
  • Proficiency in method transfer and critical reagent qualification.
  • Strong problem-solving and deviation management skills.
  • Knowledge of statistical tools.
  • Fluent in French and English (C1 level).
  • Proficient in standard IT tools.
  • Excellent collaboration and teamwork skills.
  • Ability to work independently and manage multiple priorities.
  • Effective communication skills and ability to synthesize information.
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