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 Specialist III!
The Quality Assurance 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 is a full-time, non-exempt (hourly) position. Quality Specialists are in the mid-level quality technical personnel.
This position builds upon the Quality Specialist II position, and may be asked to perform those activities as a regular part of their job. This position requires a high level of self-direction and motivation.
This individual may work on quality improvement projects, monitor NCR’s (including associated activities), revise existing procedures, train and mentor Quality Technicians, manage CAL/PM systems, process change control and implementation orders, and perform specialized inspections for raw materials.
Timely and accurate work is expected. This position regularly interacts and collaborates with other departments within BioFire. The work is fast paced, requires prioritization of daily tasks, and attention to detail. Effective communication, written and verbal, is critical.
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.
- Work on quality improvement projects, (e.g. projects stemming from CAPAs, training deficiencies, and general procedural improvements)
- May contribute to other Quality Assurance subunits that are outside of their primary Quality Assurance subunit, as assigned.
- May present project related information to management as requested.
- Work with managers to design processes in QA.
- Develop new processes where appropriate.
- Lead CAPA teams as assigned.
Training and Education:
- High school diploma or equivalent is required
- Associates degree or higher in life science or engineering discipline preferred
- Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and 21 CFR 820 required
- Completion of Medical Device Manufacturing Certificate program (provided by BioFire after hire) is required. Equivalent certifications may be considered in lieu of this certification (e.g. Six Sigma Green Belt, ASQ CQT)
- Work experience in a laboratory or life science manufacturing setting that has a formal quality system is required.
- For External Candidates: Minimum 6 years’ experience where reviewing, assessing and monitoring process and product compliance to standards was a primary job function. Education may be considered in lieu of experience.
- For Internal BioFire Candidates: Mastery of Quality Specialist II principle duties, responsibilities, and decisions or equivalent external job experience required; 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 skills as needed to maintain paperwork and task schedule.
- Proficiency in internet navigation
- Ability to develop and write standardized and clear instructions
- Ability to effectively train, mentor, and coach others
- Ability to facilitate a team to identify problems and determine root cause
- 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.
- Must be able to travel (if necessary).
Appendix I: Reagent Manufacturing
Principal Job Duties and Responsibilities:
- Determine product acceptance status after inspection.
- Evaluate and control nonconformance observed during inspection.
- Ensure good documentation practices during document review and inspection.
- Review and approve Device History records. 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. Transact the quarantined materials in appropriate systems. Review quarantined non-conforming products and confirm transactions are appropriate. Use established metrics to report on non-conforming products to managers and supervisors.
- 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. Maintain floor failures data and report metrics to area management for continual improvement.
- Prioritize product release to meet departmental goals.
- Train lower tier personnel to respective duties.
- Analyze existing processes for improvement opportunities and revise procedures accordingly.
- Develop new processes to enhance compliance, effectiveness, and efficiency within the Quality Assurance Department.
- Author Quality procedures as assigned.
- Identify opportunities to educate and coach Quality and Reagent Manufacturing personnel on proper documentation practices, maintaining proper line-clearance, and ensuring contamination prevention.
- Evaluate Quality Technician I – III and Specialist I – II processes and provide constructive feedback to increase effectiveness.
- Confirm proper documentation related to validation(s) is completed prior to product release.
- Identify where new Quality processes can be introduced to enhance: compliance, effectiveness, and efficiency.
- Review and decide if rework documentation meets requirements for approval and performance.
Current enrollment/completion of the Salt Lake Community College Medical Device Manufacturing Program or equivalent.
- 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.