Principal Quality Laboratory Technician

hace 4 semanas

Oaxaca, Oaxaca, México Johnson & Johnson Sa De Cv A tiempo completo
Job Title: Principal Quality Laboratory Technician

We are seeking a highly skilled and experienced Principal Quality Laboratory Technician to join our team at Johnson & Johnson Sa De Cv. As a key member of our Quality Control department, you will be responsible for ensuring the environmental, sterilization, in vitro, and endotoxin tests are performed in a timely and efficient manner.

Key Responsibilities:

  • Sampling and monitoring of equipment according to routine procedure.
  • Coordination with laboratories for sampling equipment as applicable.
  • Trending reports per equipment to show results as part of monitoring program.
  • Re-execution and shipping samples if failures found.
  • Review and communicate results for audits to ensure corrective and preventive actions are accurate.
  • Training and certification for visual inspection as part of cleaning program.
  • Training and certification for sampling using swabbing method for triclosan residual and degradant test.
  • Maintenance of visual inspectors and samplers' accurate and training records.
  • Shipping samples for triclosan residual to San Angelo laboratory.
  • Results receiving process, analysis of results, confirmation of acceptance or rejection results, and management of all records according to quality system.
  • Maintenance of bacterial library found in our equipment (per regulation) as part of cleaning program.
  • Manage endotoxin test results.
  • Manage in vitro test results.
  • Support Bioburden and Dose Audit Process.
  • Support Stability Studies, Biocompatibility Studies, and Microbiology and Analytical testing.
  • Support Sterilization process, including Ethylene Oxide and Gamma Irradiation.
  • Communicate business-related issues or opportunities to next management level.
  • Ensure subordinates follow all Company guidelines related to Health, Safety, and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
  • Ensure personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures.

Requirements:

  • A minimum of High School Diploma and Engineering Bachelor's Degree complete or in progress.
  • From 6 to 8 years related experience.
  • Knowledge of statistical software packages is preferred, with the ability to preview, graph, and analyze data.
  • The ability to perform 'hands-on' troubleshooting and problem-solving is preferred.
  • Knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.
  • Good written and oral communication skills, as well as report writing, presentation, and training skills in English and Spanish.
  • Ability to use software related to the activities described, spreadsheets, presentation, and word processing.
  • Bilingual: English/Spanish.

Location:

America Latina-México-Chihuahua-Ciudad Juárez

Company:

E.E.S., S.A. de C.V. Mexico (8283)

Area:

Quality Control

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