Job Information
BioFire Diagnostics, LLC. Quality Specialist - On Floor Support in Hazelwood, Missouri
Position Summary:
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). Initial schedule will be Wednesday through Saturday with a transition to another day shift schedule in 2025.
Primary Responsibilities:
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 minimum 6 years applicable experience in a GMP environment OR
Associates degree with 4+ years of applicable experience in a GMP environment OR
Bachelors degree with 2+ years of applicable experience in a GMP environment
Applicable 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