CI Specialist Job Irvine area,California USA,Engineering

Position Summary:

The Continuous Improvement (CI) Specialist will assist to build a culture centered around systematic problem solving, effective communication, efficient processes and structured training. The CI Specialist will work to reduce non-value added (Waste) processes in order to directly increase product value in terms of customer CTQ (Critical to Quality) requirements.

Condition of employment requires knowledge and conformance to Standard Operating Procedures (SOP) and Good Manufacturing Practices (GMP) as applicable to the position.

Essential Duties and Responsibilities:

Apply Lean Manufacturing and Six Sigma methodology to enterprise process and quality improvement initiatives
Identify, prioritize and scope improvement opportunities aligned with strategic and operational goals
Set priorities and workload to align analytics support with CI and business needs
Support skill development in CI tools, business acumen and business communications
Lead on-the-floor improvement discovery sessions to identify productivity opportunities and engage employees in generating solutions
Develop and facilitate curriculum for lean six sigma training and establish a culture of continued improvement
Coach and mentor Yellow and Green Belts in CI tools and mindset
Host Kaizen improvement events and run the Kaizen program across multiple manufacturing sites
Develop or facilitate programs to utilize and expand the use of lean tools such as A3 Template, Kaizen, Fishbone, Waste Walks, 5S and 5S Auditing
Review business processes to enhance effectiveness and eliminate waste
Promote process awareness and understanding throughout the organization
Implement and participate in SPQD Daily Management Multi Level meetings
Work in compliance with the company’s Health and Safety Policies/ SOPs including but not limited to the Safety Responsibility Procedure
Identify target efficiencies and production costs
Identify process efficiency improvement opportunities through the implementation of new technologies, improved methods, and optimized process flow within the facility
Update and maintain relevant SOPs and Process Documentation
Must be familiar with the following analysis techniques:
Time studies, Process Mapping and Process Flow diagrams, Statistical Process Control methodology, Statistical Analysis tools, Project Management methodology, Continuous improvement methodology (Lean-Six Sigma)
Exploring alternative/ new technologies that to improve the process, product or activity
Comply with Good Manufacturing Practices in all GMP areas

Requirements

Qualifications and Guidelines:

Minimum of five (5) years' experience in a pharmaceutical environment or similar GMP regulated environment.
Post Secondary Education Required
- Science, Technology, Engineering or Mathematics is an asset
Certification as Lean/ Six Sigma Green Belt (required) or higher is an asset
Intimate knowledge of pharmaceutical manufacturing equipment and processes i.e. dispensing, blending, compressing, coating and encapsulation
Intimate knowledge of pharmaceutical packaging equipment and processes i.e. fillers, inserters, cappers, labelers, sealers
Knowledge of secondary processes affecting product release and manufacture i.e component testing and release, raw material and finished good release, procurement, finite and strategic planning
Commensurate knowledge of pharmaceutical manufacturing control and record keeping.
Strong data analysis skills as well as relevant software packages (Excel, MS Project, Minitab, etc)
Knowledge of health, safety and ergonomics

Benefits:

Competitive salary, including discretionary performance-bases bonuses
Health Benefits (medical, dental, vision)
Life Insurance
401(k) Matching
Flexible Spending Accounts
Employee Assistance Programs
Vacation Time
Employee Recognition Programs
Learning & Development

Physical Demands and Work Conditions:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions. While performing the duties of this position, the employee…