CI Specialist

Youtheory; Irvine, Northern (CA, KY); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health Benefits

Life Insurance

401(k) Matching

Flexible Spending Accounts

Learning & Development

Job summary

Youtheory in Irvine, CA seeks a Continuous Improvement Specialist to lead Lean-Six Sigma driven improvements across manufacturing processes and SOPs. You will build a culture of problem solving, train belts, and lead on-the-floor discovery sessions to reduce waste and increase product value.

The role requires GMP familiarity, 5+ years in pharma or similar, and Green Belt certification. You will collaborate with cross-functional teams to optimize process flow, data analysis, and daily management

Qualifications

• Minimum of five (5) years' experience in a pharmaceutical environment or similar GMP regulated environment.
• Post secondary education in Science, Technology, Engineering or Mathematics is an asset.
• Lean/Six Sigma Green Belt certification (required) or higher is an asset.
• Intimate knowledge of pharmaceutical manufacturing equipment and processes.
• Strong data analysis skills and proficiency with Excel, MS Project, Minitab.
• Knowledge of health, safety and ergonomics.

Responsibilities

• Apply Lean Manufacturing and Six Sigma 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.
• Lead on-the-floor improvement discovery sessions to identify productivity opportunities and engage employees in solutions.
• Develop and facilitate curriculum for lean six sigma training and establish a culture of continued improvement.
• Coach Yellow and Green Belts in CI tools and mindset; host Kaizen events across sites.

Skills

Lean Six Sigma

Data analysis

Process improvement

Project management

Communication skills

Education

Science/Engineering/Mathematics degree

Tools

Excel

MS Project

Minitab

Job description

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 frequently is required to use hands or finger, handle, or feel objects, tools or controls. The employee is occasionally required to stand; walk; sit; reach with hands and arms; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, peripheral vision, and the ability to adjust focus. Machinery operation requires the use of safety equipment to include but not limited to; eye safety glasses, hearing protectors, work boots, and hardhats. Loose fitting clothes and jewelry are not permitted. The noise level in the work environment is usually moderate.

Our Values

ACCOUNTABILITY: We do what we say. We take personal ownership for our work and actions and its impact on others and the business.

RESPECT: We do it together authentically and inclusively. We actively listen and engage each other, including diverse perspectives.

EXCELLENCE: We drive to high standard for product, people and planet. We challenge the status quo and bring forward innovative ideas in the continuous pursuit of quality.

AGILITY: We embrace change and act with flexibility. We welcome new ideas and feedback, swiftly incorporating them to improve our performance.