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BioFire Diagnostics, LLC. Quality Specialist II - Day Shift in Salt Lake City, Utah

BioFire Diagnostics, LLC. is looking for a Quality Specialist II to join our growing day shift BioReagents Quality Assurance team. Employees in this position can perform the activities of a Quality Specialist I. All Quality Specialists may be asked to perform those activities as a regular part of their job. The Quality Assurance Specialist is responsible for completion of projects and functions supporting the BioFire Quality Management System. Specific responsibilities include working with internal departments to ensure implementation, maintenance, and improvement of quality management system. This position requires ability to learn and work with multiple computer programs and attention to detail.

This position regularly interacts and/or collaborates with other departments within BioFire. Position follows standard work practices and procedures, normally receives little or no instruction on day to day work and detailed instructions on new assignments.Principal Job Duties and Responsibilities:

  • Performs all work in compliance with company policy and within the guidelines of the BioFire Diagnostics, LLC Quality System.

  • Perform special projects as assigned by the Director of QA. These projects will be aimed at working with individuals in other departments to implement and maintain improvement opportunities that don’t meet the need for CAPA issuance. Identify QA projects and report potential projects to QA senior managers for review. Implement and maintain and QA projects list, that includes yearly review requirements and QA projects that don’t qualify for CAPA issuance.

  • Work with senior managers to design processes in QA and other areas. Develop methods to report on data processes from appropriate systems. Review reports with Quality Managers.

  • Master and use complex QC methods where appropriate. Identify and implement new QC methods as appropriate and as directed by management.

  • Ensure process compliance, as needed. Develop new processes where appropriate. Contribute to CAPA teams as appropriate. Provides testing aid and input when necessary for validations and verifications (e.g., software, firmware, hardware or new designs) and failure investigations.

  • Determination of product acceptance status after inspection.

  • Evaluation and control of non-conformances observed during inspection.

  • Ensure good documentation practices during document review and inspection.

  • Perform floor sweeps and track, report, and trend observed floor failures.

  • Prioritization of product release to meet departmental goals

  • Contribute to Internal Audits. Write sections of plans, review records and write reports on results as appropriate.

  • Lead non-conformance resolution with production teams. Facilitate Regulatory Action activities as assigned (e.g., Recall, audit prep, audit coordination)

Principal Decisions:

  • Determine when a piece of manufacturing equipment meets the requirements for release to Manufacturing Engineering for validation.

  • Determine when a piece of manufacturing equipment meets specifications for release to Reagent Manufacturing for use.

  • Review and decide if validation, verification, change order, and rework documentation meet requirements for approval and implementation.

  • Identify and conduct TCO management activities to ensure that active TCOs are correctly referenced on all applicable Reagent Manufacturing device history records.

  • Track TCO activation and expiration time frames to determine or confirm when to remove, revise, or promote TCOs to change orders.

Supplemental Data:

This is a mid-level position within the company. The employees are expected to understand the role of their team and activities of team members. The employees are also expected to understand the mission of the BioFire teams they support and understand the entirety of the Quality Management System. Qualifications

Training and Education:

  • High School diploma or equivalent required.

  • Bachelor’s Degree in life science or engineering discipline preferred. Experience in a quality, laboratory, or medical device manufacturing position at a company that has a formal quality system (e.g. ISO 9001, ISO 13485, or GMP) may substitute for a degree.

  • Demonstrate good computer skills, including proficiency in MS Word and Excel.

  • Experience or Certification in Quality Management Systems for FDA – CFR, ISO 13485, and ISO 9001 preferred but not required.

  • Current enrollment in or completion of the Salt Lake Community College Medical Device Manufacturing Program

Experience:

  • Previous experience in Quality Assurance or Quality Control equivalent to mastering responsibilities of a Quality Specialist I is required.

  • Understand Quality Management Systems compliant to FDA – CFR, ISO 13485, and ISO 9001 in their area of work.

  • Four to 7 years of experience in similar roles in QMS related activities preferred

Skills:

  • Attention to detail is fundamental to this position.

  • Expert level understanding of tools, reporting and metrics utilized by Quality Specialist I.

  • Work with teams to develop processes. Ability to write formal work instructions and train on new processes.

  • Ability to create task list and schedule to resolve tasks.

  • Effective communication skills

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.

  • Ability to distinguish colors.

  • Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR).

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