Process Improvement Specialist

About the role

The Process Improvement Specialist is responsible for identifying, developing, and implementing improvement initiatives for manufacturing processes in all stages from product formulation through packaging. The individual will work closely with all departments in the manufacturing and quality environments to drive compliance and right first-time practices.

Responsibilities

• Identify and communicate continuous improvement opportunities
• Solve complex problems by utilizing Lean, Six Sigma, or other continuous improvement tools and methodologies
• Develop metrics that provide data for process measurement, identifying indicators for future improvement opportunities
• Follow up and support investigations assigned to site Operations
• Create, review, and/or revise Master Batch Records, Standard Operating Procedures, forms, and other supporting documentation
• Jointly responsible for CAPA development with area leaders and implementation of action plans related to process improvement
• Promote teamwork and open discussion of issues as well as providing coaching and guidance to others
• Develop and perform trainings for new and existing processes including GMP training
• Perform in-process audits to ensure compliance of regulations and written instructions
• Special assignments from Manager of Production relating to process improvement

Requirements

• Bachelor Degree of Science / related field or equivalent combination of education and work experience in related field
• Excellent oral and written communication skills
• Strong emotional intelligence and change management aptitudes
• Proficient at Microsoft Outlook, Excel, Word, and PowerPoint
• Experience with quality management systems is highly preferred
• Certified in Six Sigma or a recognized troubleshooting / root cause analysis program
• Have a thorough knowledge or ability to learn applicable FDA/ Current Good Manufacturing Practices and Code of Federal Regulation as it pertains to drug manufacturing
• Must possess a steadfast quality mindset and commitment to a Good Manufacturing Practice culture
• Ability to meet attendance standards

Physical Requirements

Must be able to maneuver at least 50 pounds, climb ladders, wear a respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes

Schedule

All full-time employees are required to work a 40-hour week on the assigned shift. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines as we are a multi-shift operation.