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.
The BioFire Quality Assurance department provides Quality support across various departments within BioFire. The department is organized into six distinct subunits, consisting of 1) Calibration & Preventive Maintenance, 2) Document Control, 3) Reagents Manufacturing, 4) Instrument Manufacturing, 5) Servicing, and 6) Incoming Material QC.
Come be a part of our team and our mission as a Quality Specialist in the Reagents Manufacturing Quality team! This is a full-time, non-exempt (hourly) position within the Reagents Quality subunit, working 6:00 AM - 6:30 PM every Thurs - Sat + alternating Weds (B schedule).
This is a full-time, non-exempt (hourly) position. 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.
As a Quality Specialist on the Reagents Manufacturing Quality team, this individual primarily supports non-conformance control activities, and may also support quality improvement projects, revision of existing procedures, training and mentoring of Quality Technicians, processing of change control and implementation orders, and performing product inspections.
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.
Principal 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, employee 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.
- 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. 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.
- Review and approve Device History records.
- Prioritize product release to meet departmental goals.
- Train and mentor lower tier personnel to respective duties.
- Evaluate newly initiated NCRs to determine the appropriate real-time response.
- Analyze NCR documentation to ensure information is accurate, detailed, comprehensive, and can be understood by someone unfamiliar with Reagent Manufacturing processes.
- Determine when, in what amounts, and under what conditions non-conforming product may be physically and/or electronically released from quarantine.
- Evaluate NCR investigations to determine if additional information, data, and/or testing is needed for accurate disposition of non-conforming product.
- 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.
- Determine, perform, and confirm physical and electronic disposition activities of NCR-associated product as required by final disposition.
- Establish and maintain control of product, conforming and non-conforming, by performing or participating in inventory reconciliation.
- Determine if personnel training that has been administered is sufficient to ensure consistent execution.
- 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.
- Must be able to travel (if required). Minimal domestic travel may be required for training purposes.
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 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 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.
- 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.
- 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 write standardized and clear instructions.
- Ability to effectively train, mentor, and coach others.