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QC Assistant

The QC Assistant is responsible for inspecting and reporting on material processes and products; performing and documenting visual, dimensional and functional inspection of in-coming raw material, intermediate material and finished product; responsible for some QA related work for maintaining and improving the quality management system.

Work Environment

Equal Opportunity Employer

  • Inspect incoming materials, in-process product, and finished product including reagent, ELISA, and PCR according to the product specification by visual inspection and lab testing
  • Review batch records or notebooks for product release
  • Review packing list and other documentation to approve shipment of product as required
  • Open deviation and track until its completion
  • Open and report non-conformity products and track until its completion
  • Generate and maintain product quality control records and COA
  • Interacts with Managers, and production staff for quality inspection requirements.
  • Conduct product stability study and generate report as needed
  • Conduct investigation into customer complaint, NCR, CAR and other product related issues as needed
  • Perform data analysis and generate reports for management review and quarter review
  • Conduct other testing and inspection as required per quality system
  • Undertake other projects related to quality system improvement as assigned
  • Assist with equipment calibration or monitoring as needed

Education:

  • BS or AA in biological science or equivalent experience. IVD/Reagent experience preferred.

Experience:

  • IVD/Reagent: 1 year (Preferred)
  • FDA or ISO 13485: 1 year (Preferred)

Required Knowledge, Skills and Abilities

  • Understanding of compliance under FDA QSRs and ISO 13485
  • Excellent communication and report writing skills. A good level of English both in verbal and written communication is a must
  • Excellent Microsoft office skills, experience in FileMaker a bonus
  • Analytic and detail oriented
  • Punctual and reliable

Other Skills and Abilities:

  • Ability to write routine reports and correspondence
  • Excellent organization and attention to detail
  • Scientific writing skill
  • Ability to multi-task

Please apply through Indeed

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