Quality Specialist - Reagent Training

Location: Salt Lake City, UT, United States Position Type: Unfixed Term Job Function: Quality

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A world leader in the field of in vitro diagnostics for more than 60 years, bioMerieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 6,200 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada. Come and join a family-owned global company with a long-term vision, and a human-centered culture.

Description This is a full-time, non-exempt (hourly) position on the Reagent Quality Assurance (QA) team with an emphasis in the Reagent Training subunit. This individual will primarily support task-based training to Reagent Quality members. This position requires a high level of self-direction and motivation. Timely, accurate work is expected. The work is fast-paced, and requires prioritization of daily tasks and attention to detail. Effective communication, written and verbal, is critical. This position regularly interacts and collaborates with other departments within bioMerieux. 4x10 Schedule (Sun - Weds, 8 AM - 6:30 PM)

Principal Job Duties and Responsibilities: * Proficiently: * Inspect product (including labels) to specifications and established procedures. Determine product acceptance status after inspection. * Identify and escalate non-conformances observed during inspection. Work with production teams to resolve non-conformances where possible. * Ensure good documentation practices during quality document and quality record review. Report inconsistent or incorrect records to appropriate systems.  Work with production teams to resolve erroneous records. * Physically release work in process for finished goods processing. * File and archive quality records according to established processes. * Prioritize product release to meet department goals. * Identify and report floor failures observed during sweeps of manufacturing areas. * Review and approve Device History Records. * Receive and hold finished goods inventory until release is authorized. * Release finished goods to stock inventory. * Coordinate molded part validation inventory. * Confirm manufacturing equipment meets requirements for release to Manufacturing Engineering for validation. * Confirm manufacturing equipment meets specifications for release to Reagent Manufacturing for use. * Control (physically and electronically) material suspected to be non-conforming. * Review Non-conforming Product Reports (NCRs) for content, accuracy, and clarity. * Review and decide if rework documentation meets requirements for approval and performance. * Physically and electronically disposition NCR-related materials. * Effectively train and mentor QA personnel on Quality Specialist and Technician duties and responsibilities. * Plan and coordinate timing of training with respective leaders and other trainers. * Prioritize training to meet training goals. * Provide training of Quality Assurance procedures to Sr. Quality Technicians. * Train or assist with training new hires on required WIDs and retrain existing employees as needed per WID and SOP. * Determine if personnel training that has been administered is sufficient to ensure consistent execution. * Determine trainees' ability to retain knowledge and skills provided throughout a training. * Communicate progress of assigned trainings to leaders and other trainers. * Ensure documentation of the job training is completed for each skill as defined. * Collaborate with... For full info follow application link.

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