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BioFire Diagnostics, LLC. Quality Technician III - Instrument Service in Salt Lake City, Utah

Position Summary

The Quality Assurance department provides Quality support across various departments within BioFire. The department is organized into six distinct subunits, consisting of Calibration & Preventive Maintenance, Document Control, BioReagents Manufacturing, Instrument Manufacturing, Servicing, and Incoming Material QC.

This is a full-time, non-exempt (hourly) position. Depending on the sub-unit, this individual may review quality records, inspect manufactured products and raw materials, perform calibration and preventative maintenance on tools and equipment, and/or maintain Quality system documents and records. 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.

This position builds upon the Quality Technician II, and requires an increased level of self-direction and motivation.

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.

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

  • Verify documentation and upload to BioFire Diagnostics Quality System.

  • Follow work instruction documents to ensure batch record compliance

  • Perform visual inspection on completed instruments

  • Conduct floor sweeps

  • Verification of GMP standards; eg. Adherence to cGMP procedures and processes

  • Perform eSMI inspection

  • Provide support for compliance of preventative maintenance and calibration requirements of manufacturing equipment.

  • Perform Scrap transactions

  • Assist in trending and monitoring

  • Assist in implementation of WID and process changes

Principle Decisions

  • Identify any/all non-compliance to batch records, work instruction documents, and calibration requirements

  • Alert manager of nonconforming events.

  • Provide updates on trends and input for process improvement

Supplemental Data

  1. Minimal domestic travel may be required for training purposes

Qualifications

Training and Education

  1. High school diploma or equivalent is required

  2. Associates degree in life science or engineering discipline preferred.

  3. Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and 21 CFR 820 preferred

Experience

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

  2. Internal BioFire Candidates of Quality Technician II principle duties, responsibilities, and decisions or equivalent external job experience; education may be considered in lieu of experience.

  3. For External Candidates: Minimum 3 years’ experience where reviewing, assessing and monitoring process and product compliance to standards was a primary job focus. Education may be considered in lieu of experience.

Skills

  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 as needed to maintain paperwork and task schedule

  7. Proficiency in internet navigation

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 necessary).

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