Operations CI Associate: Lean, GMP & OEE Improvement

RXinsider LTD.; Kentucky; On-site; USD 28,929 - 38,572; Full time

Job summary

RXinsider LTD. in Ohio seeks an Operations Continuous Improvement Associate to support daily manufacturing operations in a GMP-regulated pharmaceutical packaging environment, driving process improvements and improving SQDC performance and OEE.

This role involves on-floor support, monitoring performance, Lean initiatives (6S, Kaizen, SMED), CAPA cooperation, and collaboration with QA, Engineering, and Maintenance to reduce downtime and waste.

Qualifications

• High school diploma or GED; associate degree preferred.
• 1–3 years of experience in a manufacturing environment.
• Basic understanding of GMP and regulated production environments.
• Familiarity with Lean Manufacturing principles such as 6S, Kaizen, waste reduction, and standardized work.
• Understanding of production performance metrics (OEE, scrap, downtime, yield) preferred.
• Exposure to continuous improvement or structured problem-solving methodologies preferred.
• Ability to read and interpret SOPs, batch records, and technical/controlled documentation.
• Strong analytical, problem-solving, and attention-to-detail skills.
• Proficiency in Microsoft Office applications (Excel, Word, PowerPoint).
• Strong communication and teamwork skills in a production environment.
• Ability to work in a fast-paced, regulated manufacturing setting with strict adherence to safety and quality standards.
• Strong organizational skills and ability to maintain accuracy in documentation and tasks.
• Ability to speak, read, and write English.
• Ability to obtain and maintain a mobile equipment license.

Responsibilities

• Support on-floor manufacturing operations to maintain stable, efficient production.
• Monitor processes to identify inefficiencies, defects, downtime, and performance gaps.
• Assist operators and supervisors with troubleshooting process and equipment issues.
• Ensure adherence to SOPs, batch records, and GMP procedures.
• Follow safety policies and use of PPE.
• Perform lifting up to 56 lbs and moving up to 200 lbs with assistance or equipment.
• Support Lean initiatives including 6S, Kaizen events, SMED, and standardized work implementation.
• Identify and eliminate waste (motion, waiting time, scrap, overproduction, and rework).
• Collect, analyze, and interpret production data to identify trends, losses, and improvement opportunities.
• Participate in daily tier meetings and Gemba walks to support performance tracking and improvement actions.
• Assist in implementing CAPA related to operational issues.

Skills

Lean Manufacturing

GMP Knowledge

OEE

Data analysis

Problem solving

Communication

Teamwork

Microsoft Excel

Education

High school diploma or GED

Associate degree preferred

Tools

Microsoft Excel

Job description

RXinsider LTD. in Ohio seeks an Operations Continuous Improvement Associate to support daily manufacturing operations in a GMP-regulated pharmaceutical packaging environment, driving process improvements and improving SQDC performance and OEE.

This role involves on-floor support, monitoring performance, Lean initiatives (6S, Kaizen, SMED), CAPA cooperation, and collaboration with QA, Engineering, and Maintenance to reduce downtime and waste.