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Quality Specialist III (G D & T)

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

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Description

At BioFire Diagnostics, LLC. we make the world a healthier place by providing molecular solutions that lessen the time to medical results and empower healthcare professionals to make better diagnostic decisions.

 

We are proud to be part of the bioMérieux family and the 5,000+ team members across 12 sites and subsidiaries in North America committed to our mission to help save lives around the globe through the power of diagnostics.

 

Come be a part of our team and our mission as a Quality Specialist III!

 

This is a full-time, non-exempt (hourly) position. Quality Specialists are in the mid-level quality technical personnel.

 

This position builds upon the Quality Specialist II position, and may be asked to perform those activities as a regular part of their job. This position requires a high level of self-direction and motivation. 

 

This individual may work on quality improvement projects, monitor NCR’s (including associated activities), revise existing procedures, train and mentor Quality Technicians, manage CAL/PM systems, process change control and implementation orders, and perform specialized inspections for raw materials.

 

Timely and accurate work is expected.  This position regularly interacts and collaborates with other departments within BioFire. The work is fast paced, requires prioritization of daily tasks, and attention to detail. Effective communication, written and verbal, is critical.

 

PRINCIPLE JOB DUTIES AND RESPONSIBILITIES

Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.

As a Quality representative, candidate will be responsible for reviewing, assessing and monitoring process and product to ensure compliance to requirements.

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

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

May present project related information to management as requested.

Work with managers to design processes in QA.

Develop new processes where appropriate.

Lead CAPA teams as assigned.

 

TRAINING AND EDUCATION

High school diploma or equivalent is required

Associates degree or higher in life science or engineering discipline preferred

Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and 21 CFR 820 required

Completion of Medical Device Manufacturing Certificate program (provided by BioFire after hire) is required. Equivalent certifications may be considered in lieu of this certification (e.g. Six Sigma Green Belt, ASQ CQT)

Work experience in a laboratory or life science manufacturing setting that has a formal quality system is required.

For External Candidates: Minimum 6 years’ experience where reviewing, assessing and monitoring process and product compliance to standards was a primary job function. Education may be considered in lieu of experience.

For Internal BioFire Candidates: Mastery of Quality Specialist II principle duties, responsibilities, and decisions or equivalent external job experience required; education may be considered in lieu of experience.

 

SKILLS

Special skills required (e.g., negotiation, technical writing; statistical evaluation).

  1. Effective written and verbal communication skills
  2. Proficiency in MS Office tools, including Outlook, Word, and Excel
  3. General computer operation
  4. Attention to detail is fundamental to this position.
  5. Ability to accurately follow written and verbal instructions.
  6. Organization skills as needed to maintain paperwork and task schedule.
  7. Proficiency in internet navigation
  8. Ability to develop and write standardized and clear instructions
  9. Ability to effectively train, mentor, and coach others
  10. Ability to facilitate a team to identify problems and determine root cause

 

PHYSICAL REQUIREMENTS

Must be able to lift at least 25 lbs and may be required to lift up to 50 lbs. Must be able to sit or stand for moderate amounts of time and look at computer monitors for an extended amount of time with or without accommodation.

Must be able to travel (if required for training).

Perception of and ability to distinguish colors

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