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BioFire Diagnostics, LLC. Process Improvement Coordinator III in Salt Lake City, Utah

BioFire Diagnostics, LLC. is looking for a Process Improvement Coordinator III to join our growing team! Process Improvement Coordinator III will be responsible for implementing process improvement initiatives throughout the Reagent Manufacturing department and assists the team with administrative and project coordination activities. Supports the development of new processes and drives continuous improvement to existing manual and automated processes. This individual is expected to communicate well with throughout the organization and with manufacturing leadership, engineering, quality, project management, and technicians.

Essential Job Duties and Responsibilities

  • Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.

  • Supports process development of new processes, and continuous improvement to existing manual and automated processes.

  • Study current state processes and proactively find opportunities for safety, quality, productivity, and cost improvements throughout reagent manufacturing.

  • Facilitate kaizen initiatives.

  • Root cause analysis and problem solving requiring data collection, statistical analysis, and reporting.

  • Support and mentor green belt projects from individuals throughout manufacturing. Ensure results of green belt efforts are reported to senior management.

  • Support system development to engage all levels in continuous improvement.

  • Follows company policy, SOPs, WIDs, cGMP, ISO 13485, and FDA guidelines and requirements.

  • Participates with the manufacturing support teams and maintain schedules and timelines for all assigned kaizen initiatives.

  • Drafts and deploys standardized work and corresponding documentation throughout reagent manufacturing.

  • Deliver training as required on lean, six sigma and continuous improvement topics.

  • Performs other duties as assigned.

Minimum Qualifications

Training & Education: High School diploma or equivalent. A Bachelor’s degree in a Life Science or Manufacturing/Business Operations is preferred, but not required.

Lean Six Sigma Certification Minimum Green Belt required (Other lean, or six sigma certifications will be considered)

Experience:

  • 5years of experience working in and cGMP manufacturing facility. Experience in continuous improvement, lean manufacturing, operational excellence, or six sigma required. Experience making improvements in an automated manufacturing environment. Experience in PCR based medical device-systems preferred.

  • A Bachelor’s degree in Life Science or Manufacturing/Business Operations plus two years continuous improvement, lean manufacturing, operational excellence, or six sigma can be substituted for the five years of required experience.

Knowledge, Skills, and Abilities:

  • Comprehensive understanding of industry regulations,cGMP compliance and high throughput manufacturing

  • Highly skilled at facilitating Kaizenand engaging teams in completing kaizen initiatives

  • In-depth understating of 5s and Lean Manufacturing principles

  • Strong problem-solving skillsfor both proactive an reactive improvements and high level of attention to detail

  • Demonstrate high-level of business judgment and clear communication with cross-functional teams and others at all levels of the organization

  • Demonstrated organizational and mentoring skills

  • Ability to work independently with minimal supervision

  • Ability to manage numerous priorities simultaneously

  • Ability to shift priorities to meet required deadlines

  • Minitab, statistical, statistical process control and mathematical skills

  • Must be proficient with Microsoft Office applications, including Word, Excel and Power Point.

  • Design of experiments

  • Project Leadership

  • Training and development

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

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