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Quality Control Supv II

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Quality Control Supv II

  • 2020-14572
  • Irvine, CA, United States

Supervise two teams, one team performs biological raw material, in-process and finished product testing of the infectious disease serology/molecular quality control lines; the other team performs component receiving inspection in a warehouse environment.

Responsibilities

  • Supervise QC specialists and technicians to perform material inspection and testing throughout the production process to meet production schedule safely and in compliance to standards.
  • Compile and review test and batch records to meet internal and external quality requirements
  • Submit batch documentation to EU Notified Body for List A product batch review under IVDD
  • Monitor the calibration/maintenance status of ID/Molec QC equipment to assure they meet specified requirements.
  • Lead team toward more efficient processes to reduce direct costs and overhead, while encouraging individual development and cross-training
  • Maintain productivity, efficiency and quality metrics for QC activities.

Qualifications

  • Bachelor’s degree in a laboratory science
  • 6+ years quality control or manufacturing experience
  • Strong communication, public speaking, problem-solving, MS Office and negotiation skills
  • Strong technical and analytical skills required
  • Familiarity with SAP a plus
  • Understanding of ISO 13485 and FDA GMP/GLP regulations required

 

 

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