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 III!
The 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. This opening is for our BioReagents Manufacturing QA group - Team A (Day shift, 12 hours: 6:00 AM - 6:30 PM, Sun - Wed).
This is a full-time, non-exempt (hourly) position. This individual will primarily review quality records and inspect manufactured products. Timely and accurate work is expected. The work is fast paced, 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. This position builds upon the BioReagents 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.
- 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.
- 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.
- 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.
Training and Education
- High school diploma or equivalent is required.
- Associates degree in life sciences or engineering discipline preferred.
- Knowledge of good manufacturing practices (cGMP), 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: 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