QC Associate Scientist

vor 1 Woche

Neuenburg, Neuenburg, Schweiz SimplyVision GmbH Vollzeit

For our customer located in Neuchatel / Switzerland we are currently looking for a : QC Associate Scientist (m / f / d)

Tasks & Responsibilities

Duties

The job holder is accountable for life cycle management activities of analytical assays performed in the QC Laboratories of Neuchâtel – Switzerland with a focus on :

  • Laboratory Investigations
  • Critical Material Qualification
  • Laboratory Method Transfers

In addition, the job holder also supports daily QC activities following cGMP, Pharma policies and EHS requirements.

Validation and Qualification Activities

  • Author transfer protocols and reports for assays
  • Author qualification plans and reports for critical reagents
  • Oversee validation and qualification activities executed by analysts, provide training and support
  • Execute and document experiments

Investigation Leads

  • Investigate and troubleshoot problems which occur to determine solutions or recommendations for improvements or change
  • Conduct / participate in risk assessments, root cause analysis and investigations
  • Own Laboratory Investigations and CAPA

Quality Control Support Activities

  • Support the application of industry specific compliance standards / regulations to assays life cycle management activities
  • Participate in daily activities upon request (provide technical and statistical support)

Must Haves

Experience

  • University or engineering degree in analytical chemistry, biotechnology, biochemistry
  • 1 or 2 years of experience in GMP pharma business activities, preferably in the scope of recombinant therapeutic product in pharmaceutical environment
  • Experience in GMP Laboratory activities
  • Good knowledge of method transfer
  • Good knowledge of critical reagent qualification
  • Experience in problem solving and deviation management
  • Good knowledge of statistical tools
  • Fluent in French and English (C1 written and spoken)
  • Proficiency in all aspects of standard IT tools
  • Excellent collaboration skills and teamwork mindset
  • Good troubleshooting and problem-solving skills
  • Ability to work independently in a fast-paced environment
  • Ability to manage multiple priorities and know when to escalate issues for resolution
  • Demonstrated ability to synthesize information
  • Demonstrated ability to give and receive feedback
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