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BioFire Diagnostics, LLC. Quality Technician II - D Schedule in Salt Lake City, Utah

BioFire Diagnostics, LLC. is looking for 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 Calibration & Preventive Maintenance, Document Control, BioReagents Manufacturing, Instrument Manufacturing, Servicing, and Incoming Material QC.

PLEASE NOTE: Beginning January 3, 2021, the working schedule for this position will be every Every Other Wednesday + Thursday - Saturday 6:00 PM - 6:00 AM.

Position Summary:

This is a full-time, non-exempt (hourly) position on the BioReagents 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:

  • Determination of product acceptance status after inspection.

  • Identification and escalation of non-conformances observed during inspection.

  • Ensure good documentation practices during document review and inspection.

  • Identify and report floor failures observed during sweeps and/or inspections.

  • Review and approve Device History Records. Report inconsistent or incorrect records to appropriate systems. Report errors to supervisor.

  • Release work-in-process to finished goods inventory.

  • Inspect product to specifications or process. Report non-conforming product to appropriate systems. Report errors to supervisor.

  • Performs QC testing as needed. Understanding and use of elementary test methods is expected.

  • Performs all work in compliance with company policy and within the guidelines of the BioFire Diagnostics, LLC Quality System.

  • Ensure process compliance, as needed. Report on process compliance where appropriate.

  • Report observations to supervisors using established metrics.

  • Provides assistance in other QA department duties and projects as assigned.

Principal Decisions:

  • Inspection of manufacturing documentation and quality records to determine if product meets specifications and may be released to packaging.

  • 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.

  • Identification and escalation of failures observed during performance of fitment and plunger functional testing.

  • Evaluation of BioReagent 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:

  • 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 GMP) may substitute for a degree.

  • Demonstrate good computer skills, including proficiency in MS Word and Excel.

Experience:

  • Previous experience in Quality Assurance or Quality Control equivalent to mastering responsibilities of a Quality Technician I is required. An Associate‚Äôs degree many substitute for this experience.

  • On-the-job experience sufficient to ensure professional communication and interactions.

Skills:

  • Attention to detail is fundamental to this position

  • Ability to accurately follow written and verbal instructions

  • Organization skills as needed to maintain paperwork and task schedule

  • 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).

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