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
- 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.
- Determine product acceptance status after inspection.
- Identify and escalate non-conformances observed during inspection.
- Ensure good documentation practices during document review and inspection.
- 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.
- 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.
- Physically quarantine non-conforming products and seek guidance on reporting the quarantined materials
- Performs QC testing and sample retrieval as needed. Understanding and use of sampling acceptance methods is expected.
- Identify and report floor failures observed during sweeps and/or inspections.
- Review and approve Device History records.
- Prioritize product release to meet departmental goals.
- 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.
- Evaluate acceptance status activities to ensure that only conforming product is released for distribution.
- Prioritize final product release to maintain inventory levels and avoid product backorders.
- Coordinate Fitment and Plunger Functional Testing.
- 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.
Training and Education
- High school diploma or equivalent is required
- Associates degree in life science or engineering discipline preferred.
- Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and 21 CFR 820 preferred
- Work experience in a laboratory or life science manufacturing setting that has a formal quality system is preferred
- 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.
- 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.
- Effective written and verbal communication skills
- Proficiency in MS Office tools, including Outlook, Word, and Excel
- General computer operation
- Attention to detail is fundamental to this position
- Ability to accurately follow written and verbal instructions
- Organization as needed to maintain paperwork and task schedule
- Proficiency in internet navigation
- 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.
- Perception of and ability to distinguish colors
- Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR) as needed.
- Must be able to perform duties in a clean room environment. This requires the use of work attire provided and laundered by BioFire Diagnostics.