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BioFire Diagnostics, LLC. Lead Laboratory Technologist - Quality Control (Day Shift) in Salt Lake City, Utah

BioFire Diagnostics, LLC. is looking for a Lead QC Technologist to join our growing Quality Control team! The QC Technologist Lead performs the duties of a QC Technologist commensurate with years of experience. The Lead spends, on average, 75% of their time on QC Technologist duties and 25% on Lead duties. The Lead is responsible for organizing and motivating team members and for providing back-up when the QC Supervisor is unavailable to lead the team in execution of the daily work schedule. Responsible for coordinating work activities of Technicians and Technologists in an assigned area of responsibility. This position will actively interact with all QC employees in assigned area of responsibility to help in the training of continual quality and production improvement within the QC department. Works on assignments where judgment and initiative is required in resolving problems and making recommendations. Works under immediate supervision and reports to the QC Supervisor.QC Technologist job tasks include: Working in a cGMP environment performing quality control testing for commercial and diagnostics products. Responsibilities include conducting testing of reagents and IVD materials as well as personnel swabs. Responsibilities include working with Manufacturing, Technology Transfer and other departments for data collections and validations for new product QC qualifications, organization of quality controlled materials used for QC testing and learning new techniques or workflow as required by new product lines. Responsible for gathering and filling out quality documents pertaining to quality control testing, generation of Non Conformance Report (NCR) when necessary and Temporary Change Order (TCO) application. Provides assistance in QC document revision and assistance with product releases at the direction of the QC Supervisor. This position will work in a laboratory setting and perform a variety of scientific techniques, including spectrophotometry, PCR, pipetting, Essential Job Duties and Responsibilities, etc. PLEASE NOTE: The working schedule for this position is Sunday - Tuesday + every other Wednesday from 6:00 AM - 6:00 PMEssential Job Duties and Responsibilities 1. Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.2. Perform quality control testing on incoming reagents used in Film Array.3. Maintain supplies as well as coordinating instrument/equipment repairs as necessary. 4. Provide support if needed in other projects or validations from various departments within the company. 5. Responsible for learning new techniques or workflows as required for new product lines.6. Responsible for personnel swab set up and reporting.7. Perform accurate and efficient QC data entry.8. Maintain the QC area to ensure it is clean and contamination-free including participation in cleaning and swabbing as assigned.9. Coordinate repeat testing activities.10. Works closely with QC Supervisor and colleagues to ensure consistent and timely turnaround for QC results.11. Maintain records as required by the Quality System.12. Provide training for new employees.13. Assists with data review and component release as directed.14. Respond to inquiries and reviewing corrections.15. Assists with product release in Production Web and Component QC Tool as directed.16. Provides help or assistance in QC document revisions.17. Coordinates work activities in an assigned area of responsibility18. Maintains the rotating work schedule devised by the QC Supervisor19. Monitors Technician and Technologist performance and reports results to management20. Follows written work instructions and collects all relevant data21. Reports daily metrics to management22. Helps Technicians and Technologists troubleshoot problems23. Assists with NCR investigation as assigned24. May take inventory and place internal orders25. Works with Project Managers to implement process improvements 26. Must develop/maintain a strong technical knowledge and troubleshooting skills for all final QC testing27. Performs additional job functions as directed by the QC Management TeamSupplemental Data

  • This position has no HR/Personnel responsibilities

  • Must work assigned shift

  • Must work mandatory overtime as assigned

    QualificationsTraining and Education:Associate's Degree or higher in a Life Science or related field. Experience

Fulfill requirements of a QC Technologist II or III AND have worked in the BioFire QC laboratory for at least one year. Prior Lead or Supervisory experience may be substituted for 1 year experience in the QC laboratory.Knowledge, Skills and Abilities

• Demonstrated leadership skills• Demonstrated commitment to BioFire Diagnostic’s QC laboratory• Proactive and takes initiative• Quality-driven • Ability to accurately follow both written and verbal instructions• Demonstrated proficiency with Microsoft Office Suite• Highly collaborative and team oriented• Effective communication skills, both written and verbal• Demonstrated proper pipetting technique• Experience with descriptive statistics desiredPhysical Requirements• Must be able to lift 25 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 perform duties wearing a Powered Air Purifying Respirator (PAPR)