Quality Specialist I - Reagents (D Schedule)

Quality Specialists are mid-level quality technical personnel. This position builds upon the Quality Technician III position, depending on the sub-unit, this individual 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.

1. Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
2. As a Quality representative, employee will be responsible for reviewing, assessing and monitoring process and product to ensure compliance to requirements.
3. Work on quality improvement projects, (e.g. projects stemming from CAPAs, training deficiencies, and general procedural improvements)
4. May contribute to other Quality Assurance subunits that are outside of their primary Quality Assurance subunit, as assigned.
5. Determine product acceptance status after inspection.
6. Identify and escalate non-conformances observed during inspection
7. Ensure good documentation practices during document review and inspection.
8. 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.
9. 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.
10. 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.
11. Performs QC testing and sample retrieval as needed. Understanding and use of sampling acceptance methods is expected.
12. Identify and report floor failures observed during sweeps and/or inspections.
13. Review and approve Device History records
14. Prioritize product release to meet departmental goals.
15. Train and menor lower tier personnel to respective duties

1. Evaluate newly initiated NCRs to determine the appropriate real-time response.
2. Analyze NCR documentation to ensure information is accurate, detailed, comprehensive, and can be understood by someone unfamiliar with Reagent Manufacturing processes.
3. Determine when, in what amounts, and under what conditions non-conforming product may be physically and/or electronically released from quarantine.
4. Evaluate NCR investigations to determine if additional information, data, and/or testing is needed for accurate disposition of non-conforming product.
5. During final NCR review, determine if non-conforming product will be reworked, scrapped, or may be released by Quality Technician IIIs during Device History Record (DHR) review.
6. Determine, perform, and confirm physical and electronic disposition activities of NCR-associated product as required by final disposition.
7. Establish and maintain control of product, conforming and non-conforming, by performing or participating in inventory reconciliation.
8. Determine if personnel training that has been administered is sufficient to ensure consistent execution.

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 required
4. 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
   

1. Work experience in a laboratory or life science manufacturing setting that has a formal quality system is required.
2. For External Candidates: Minimum 4 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.
3. For Internal BioFire Candidates: Mastery of Quality Technician III principle duties, responsibilities, and decisions or equivalent external job experience required; education may be considered in lieu of experience.
   

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 skills as needed to maintain paperwork and task schedule.
7. Proficiency in internet navigation
8. Ability to write standardized and clear instructions
9. Ability to effectively train, mentor, and coach others
   

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 required).