Process Improvement Coordinator II or III

Description

Position Summary:

The 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. This position will be under the direct supervision of the Process Improvement Supervisor. This coordinator is responsible for supporting process development of new processes and drive continuous improvement to existing processes both manual and automated processes. This individual is expected to work and communicate well with teams throughout the organization. Specifically, this individual is expected to communicate well with manufacturing leadership, engineering, quality, project management, and technicians. This individual is expected to be skilled at facilitating kaizen initiatives and engaging teams in completing kaizen initiatives. This individual should be very capable at doing root cause analysis and detailed problem solving for both proactive and reactive improvements.

Principal Job Duties and Responsibilities:  

1. Responsible for supporting process development of new processes, and continuous improvement to existing processes both manual and automated processes.
2. Study current state processes and proactively find opportunities for safety, quality, productivity, and cost improvements throughout reagent manufacturing.
3. Facilitate kaizen initiatives.
4. Root cause analysis and problem-solving requiring data collection, statistical analysis, and reporting.
5. Support and mentor green belt projects from individuals throughout manufacturing. Ensure results of green belt efforts are reported to senior management.
6. Support system development to engage all levels in continuous improvement.
7. Follows company policy, SOPs, WIDs, cGMP, ISO 13485, and FDA guidelines and requirements.
8. Participates with the continuous improvement steering committee and maintains schedules and timelines for all assigned kaizen initiatives.
9. Capable in drafting standardized work documentation and deploying standardized work throughout reagent manufacturing.
10. Deliver training as required on lean, six sigma and continuous improvement topics.
11. Other duties as assigned.

Qualifications

Training and Education: 

• A degree in a Life Science or Manufacturing/Business Operations is preferred, but not required.
• 5-10 years of experience working in and cGMP manufacturing facility. Experience in continuous improvement required.
• Lean Six Sigma Certification Minimum Green Belt required (Other lean, or six sigma certifications will be considered)

Skills:  

• Comprehensive understanding of industry regulations and cGMP compliance
• Demonstrated understanding of Kaizen, 5s, and Lean Manufacturing principles
• Experience in PCR based medical device-systems
• Experience in high throughput manufacturing
• Strong problem-solving skills and extreme 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
  Effectively communicate issues cross-functionally in a timely manner
• Statistical and mathematical skills
  Must be proficient with Microsoft Office applications, including Word, Excel and Power Point.
• Minitab
• Design of experiments
• Six Sigma or CQE certification
• Lean certification
• Statistical process control
• Project Leadership
• Training and development
• Experience making improvements in an automated manufacturing environment

Physical Requirements: 

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

 
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