Laboratory & QC Technician

Reference Number: 896114-W
Type of placement: Contract, 9 months
Location: CH, NW

Introduction:

Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking a Laboratory & QC Technician for 9 months contract based in the Basel area.

The ideal candidate should have at least 7 years of experience in laboratory functional testing, laboratory equipment qualification and maintenance and statistical hands-on practices for medical devices or combination product testing.

Main Responsibilities:

  • Collaborate with the Product technical experts, quality engineering, and suppliers (where appropriate), define equipment required for each test methods, procure and qualify equipment including protocols and reports writing;
  • Create the equipment calibration and maintenance plan;
  • Elaborate/Develop test methods required by product functions to test;
  • Procure and control test method fixture to requirement;
  • Create test method validation protocol and acceptance criteria (variable data or attributes), procure tests parts, execute test method validation and write associated report;
  • Transfer method from/with suppliers including equivalency tests method statistical criteria for qualification and validation and execute transfer,
  • Manage Product storage and pre-conditioning required prior to testing and  perform all functional test internally and support testing with service Providers for sub-contracted tests;
  • Create and Maintain a laboratory notebook and ensure raw data integrity and accuracy using a four-eyes principle. Analyze any test failure, demonstrating if it is test method related or product related. Where product related, collaborate pro-actively with technical expert for investigations and resolution;
  • Guarantee the quality of testing and accuracy of reported data and ensure method validation prior to testing execution.

Qualifications and Experience:

  • Minimum 7 years of experience in laboratory functional testing, laboratory equipment qualification and maintenance and statistical hands-on practices for medical devices or Combination product testing;
  • Demonstrated functional test validation expertise for both variable and attribute test methods;
  • Demonstrated laboratory equipment and control knowledge and compliance to GLP;
  • Advanced skills in method validation and  statistical knowledge(use of Minitab);
  • Preferably knowledge of Medical Device ISO standard test method;
  • Demonstrate and promote leadership courage by doing what is right. Instill confidence to team in the reliability of testing;
  • Meticulous with particular attention to details for validation and testing;
  • Relevant working/residency permit or Swiss/EU-Citizenship required.

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