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Quality Technician III - Reagents (B Schedule)

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

Description

Principle Job Duties and Responsibilities
  1. Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
  2. As a Quality representative, candidate will be responsible for reviewing, assessing and monitoring process and product to ensure compliance to requirements.
  3. May contribute to other Quality Assurance subunits that are outside of their primary Quality Assurance subunit, as assigned.
  4. Determine product acceptance status after inspection.
  5. Identify and escalate non-conformances observed during inspection.
  6. Ensure good documentation practices during document review and inspection.
  7. Release work in process to finished goods inventory. Report inconsistent or incorrect records to appropriate systems.  Report errors to supervisor. Work with production teams to resolve erroneous records.
  8. Inspect product to specification or process. Report non-conforming product to appropriate systems.  Report errors to supervisor. Work with production teams to resolve non-conformances where possible.
  9. Physically quarantine non-conforming products and seek guidance on reporting the quarantined materials
  10. Performs QC testing and sample retrieval as needed. Understanding and use of sampling acceptance methods is expected.
  11. Identify and report floor failures observed during sweeps and/or inspections.
  12. Review and approve Device History records.
  13. Prioritize product release to meet departmental goals.
Principle Decisions
  1. Analyze Pouch Device History Records (DHRs) to confirm the presence, accuracy, and completeness of all quality records associated with the manufacture of product in Reagent Manufacturing.
  2. Evaluate acceptance status activities to ensure that only conforming product is released for distribution.
  3. Prioritize final product release to maintain inventory levels and avoid product backorders.
  4. Coordinate Fitment and Plunger Functional Testing.
  5. Assess fitment and plunger functional testing data and specifications for the release of conforming parts to Reagent Manufacturing or generation of an NCR for investigation and disposition of non-conforming parts or processes.
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: Mastery 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
  1. Must be able to lift at least 25 lbs and may be required to lift up to 50 lbs.
  2. 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.
  3. Perception of and ability to distinguish colors
  4. Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR) as needed.
  5. Must be able to perform duties in a clean room environment.  This requires the use of work attire provided and laundered by BioFire Diagnostics.
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