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BioFire Diagnostics, LLC. Quality Specialist - On Floor Support: 1st Shift in Hazelwood, Missouri

Position Summary & Responsibilities:

The normal working hours for this role are anticipated to be Monday-Friday 6:00am -2:30pm. The Quality Inspection Specialist is responsible for performing physical inspection of card batches on the production floor, supports quality walkthroughs of production areas and changeovers between batches (as applicable).

  • Utilize AQL sampling guidance to inspect cards, pouches, and cartons for physical anomalies or rejects.

  • May support containment of rejected materials.

  • Supports nonconformance investigations using Root Cause Analysis tools (i.e. 5 WHYS, 5M+E, Is/Is Not, etc.) as required.

  • Perform walk throughs to support technicians in comments, quality decisions, and procedure questions.

  • Implements and completes continuous improvement projects as required.

  • Collaborate with Final QC lab for card inspection results.

    Education, Skills, & Experience:

  • High school diploma or GED with 6+ years of experience working in a manufacturing environment.

  • Associates degree with 4+ years of experience working in a manufacturing environment also accepted

  • Bachelors degree with 2+ years of experience working in a manufacturing environment also accepted

  • Experience working in a GMP and FDA related production environment

  • Exhibits strong analytical and problem-solving skills. Clearly expresses ideas (verbal and written) and demonstrates the ability to utilize Quality Engineering tools and techniques effectively.

  • Familiarity with relevant domestic and international regulations and industry standards (e.g. ISO, FDA QSR).

  • Strong interpersonal skills and ability to work with all levels of an organization.

  • PC skills, including proficiency in: Microsoft Excel, PowerPoint, Outlook and Word.

  • Prior knowledge of MES, SPC, or SAP a plus

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