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Quality Technician II - C Schedule

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

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 Technician II to join our growing BioReagents Quality Assurance Team!

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

Position Summary:

This is a full-time, non-exempt (hourly) position on the Reagents Manufacturing Quality Assurance (QA) team. This individual will primarily review quality records and inspect manufactured products. Timely and 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 BioFire. The work is performed in real-time following standard practices and in accordance with the Quality System.

 

Principal Job Duties and Responsibilities:

  1. Determination of product acceptance status after inspection.
  2. Identification and escalation of non-conformances observed during inspection.
  3. Ensure good documentation practices during document review and inspection.
  4. Identify and report floor failures observed during sweeps and/or inspections.
  5. Review and approve Device History Records. Report inconsistent or incorrect records to appropriate systems. Report errors to supervisor.
  6. Release work-in-process to finished goods inventory.
  7. Inspect product to specifications or process. Report non-conforming product to appropriate systems. Report errors to supervisor.
  8. Performs QC testing as needed. Understanding and use of elementary test methods is expected. 
  9. Performs all work in compliance with company policy and within the guidelines of the BioFire Diagnostics, LLC Quality System.
  10. Ensure process compliance, as needed. Report on process compliance where appropriate.
  11. Report observations to supervisors using established metrics.
  12. Provides assistance in other QA department duties and projects as assigned.

 

Principal Decisions:

  1. Inspection of manufacturing documentation and quality records to determine if product meets specifications and may be released to packaging.
  2. Daily analysis of pouch hydration and burst in-process QC test data to ensure presence and accuracy, or if missing or incorrect data is observed, escalate for investigation.
  3. Identification and escalation of failures observed during performance of fitment and plunger functional testing.
  4. Evaluation of Reagent Manufacturing practices, personnel training records, and environment during floor sweeps to identify and report non-conformances and areas of potential improvement.

 

Supplemental Data: 

This is an entry-level position within the company.  These employees are expected to understand the role of their team and activities of team members.

 

QUALIFICATIONS

 Training and Education: 

  1. Associates Degree in life science or engineering discipline preferred. Experience in a quality, laboratory, or medical device manufacturing position at a company that has a formal quality system (e.g. ISO 9001, ISO 13485, or cGMP) may substitute for a degree.
  2. Demonstrate good computer skills, including proficiency in MS Word and Excel.

 

Experience: 

  1. Previous experience in Quality Assurance or Quality Control equivalent to mastering responsibilities of a Quality Technician I is required. An Associate’s degree many substitute for this experience.
  2. On-the-job experience sufficient to ensure professional communication and interactions.

 

Skills:  

  1. Attention to detail is fundamental to this position
  2. Ability to accurately follow written and verbal instructions
  3. Organization skills as needed to maintain paperwork and task schedule
  4. Effective communication skills

 

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.
  • Ability to distinguish colors.
  • Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR).

BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.

Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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