Quality Assurance Specialist
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Essential 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.
- Perform inspection of incoming materials using basic and advanced measurement tools
- Perform quarantine activities including physical and electronic segregation, labeling, physical and electronic release.
- Initiate NCRs with a thorough description of the nonconformance including target as well as discrepancy, quantity and standard used for rejection
- Complete first article inspections.
- Perform and manage sorting activities to completion
- Identify need for work instruction updates and initiate/author the updates
- Support and/or manage validation testing, e.g. GR&R and program validation activities.
- Initiate and author inspection plan documents
- Support/interact with Materials Management, Engineers, Purchasing, and suppliers. This includes research activities and special projects.
- Perform sweeps of warehouse area to ensure cGMP compliance with a lead auditor
- Review co-worker completed inspection records
- Mentor technicians
- Initiate routines and programs for metrology tools under engineer guidance
- Coordinate activities for metrology tool calibration
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)
- 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.
- Prefer specialized GD&T background, problem solving, technical writing, black belt.
- Demonstrated skill set and knowledge of inspection methodologies and techniques through competency testing during the interview process.
Knowledge, Skills, and Abilities
- 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
- 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).
BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).