Quality Specialist: Reagent Quality (A Shift) at bioMerieux
West Jordan, UT 84084
About the Job
A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions which determine sources of disease and contamination to improve patient health and ensure consumer safety.
In North America we have more than 5,000 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics. Come and join an amazing global company with a solid long-term vision and an excellent human-centered culture as a Quality Specialist on our Reagent Quality Team!
Job Summary
The overall Salt Lake City Quality Assurance (QA) department provides Quality support across various departments, and is organized into distinct subunits, including Reagent Quality, Metrology, Calibration & Preventive Maintenance, Document Control, Quality Auditing, Instrument Quality, Servicing Quality, Incoming Material QC. This opening is on the Reagent Quality team.
This is a full-time, non-exempt (hourly) position on the Reagent Quality team. This individual will primarily support non-conformance response activities, and may also contribute to other quality functions. This position requires a high level of self-direction and motivation. Timely, accurate work is expected. The work is fast-paced, and 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 bioMerieux. The work is performed in real-time following standard practices and in accordance with the Quality System.
Principle Job Duties and Responsibilities:
- Perform all work in compliance with company policy and within the guidelines of its Quality System.
- 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.
- Work on quality improvement projects, (e.g. projects stemming from CAPAs, training deficiencies, and general procedural improvements)
- May present project related information to management as requested.
- Inspect product (including labels) to specifications and established procedures. Determine product acceptance status after inspection.
- Identify and escalate non-conformances observed during inspection. Work with production teams to resolve non-conformances where possible.
- Ensure good documentation practices during quality document and quality record review. Report inconsistent or incorrect records to appropriate systems. Work with production teams to resolve erroneous records.
- Physically release work in process for finished goods processing
- File and archive quality records according to established processes.
- Prioritize product release to meet department goals
- Identify and report floor failures observed during sweeps of manufacturing areas.
- Review and approve Device History Records.
- Receive and hold finished goods inventory until release is authorized
- Release finished goods to stock inventory
- Confirm manufacturing equipment meets requirements for release to Manufacturing Engineering for validation.
- Confirm manufacturing equipment meets specifications for release to Reagent Manufacturing for use.
- Control (physically and electronically) material suspected to be non-conforming
- Review Non-conforming Product Reports (NCRs) for content, accuracy, and clarity
- Review and decide if rework documentation meets requirements for approval and performance
- Physically and electronically disposition NCR-related materials
QUALIFICATIONS
Training and Education:
- High school diploma or equivalent is required.
- Associate degree (or higher) in a life science or engineering discipline is preferred.
- Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is required.
- Enrollment in the Salt Lake Community College Medical Device Manufacturing Program or equivalent (e.g. ASQ certification; Six Sigma certification; life science or engineering related college degree).
Experience:
- Minimum 1-year previous on-the-job experience requiring professional communication and interactions utilizing skills outlined below.
- Minimum additional 2-year experience in a Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system. Education/certification in Quality Management Systems may be used in lieu of 1-year of this experience.
Skills:
- 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
- Basic math proficiency
- Ability to write standardized and clear instructions
Physical Requirements:
- 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).
- Must be willing to submit to a color-vision test, though result of the test will not determine employment eligibility
- 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 the company.
- Must be able to push, pull, bend, and/or lift at least 25 lbs, and may be required to lift up to 50 lbs., for extended periods of time on a daily basis.
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