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BIOMERIEUX, INC. Quality Specialist in SALT LAKE CITY, Utah

Quality Specialist

 

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

Position Summary:

The Quality Assurance (QA) department provides Quality support across various company departments. The department is organized into distinct subunits, consisting of Metrology, Document Control, Reagent Quality, Instrument Quality, Servicing Quality, and Incoming Material QC.

Depending on the sub-unit, Quality Specialists may work on quality improvement projects, monitor NCR's (including associated activities), revise existing procedures, train and mentor QA personnel, manage CAL/PM systems, process change control and implementation orders, and perform specialized inspections for raw materials. This position builds upon the skills and responsibilities of a Senior Quality Technician and requires an increased level of self-direction and motivation.

This position requires a high level of self-direction and motivation.  Timely and accurate work is expected.  This position regularly interacts and collaborates with other departments. The work is fast paced, requires prioritization of daily tasks, and attention to detail. Effective communication, written and verbal, is critical.

Primary Duties:

  • Perform all work in compliance with company policy and within the guidelines of its Quality System.

  • Responsible for reviewing, assessing and monitoring process and product to ensure compliance to requirements.

  • May contribute to other Quality Assurance subunits that are outside of their primary Quality Assurance subunit, as assigned.

  • Work on quality improvement projects, (e.g. projects stemming from CAPAs, training deficiencies, and general procedural improvements)

  • May present project related information to management as requested.

  • 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 Reagen t 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... For full info follow application link.

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