Continuous Improvement Investigator

Description Overview

The Continuous Improvement Investigator is responsible for investigating and resolving Operational Deviation Reports (ODRs) alongside the Continuous Improvement Engineer (CIE), Operations, Maintenance and Quality. They will be responsible for collecting and presenting information for product disposition, root cause identification, corrective action development and implementation, and maintaining compliance with regulatory and quality requirements.

This role is primarily first shift hours but will need to flex their schedule as needed depending on any investigational needs. Occasional travel may be required.

Scope of the Role

• Investigate deviations from standard operating procedure (SOPs), quality specifications, and regulatory requirements filed at the Perrigo Ohio manufacturing site.
• Work cross-functionally to gather the necessary information that establishes scope and supports product risk assessments.
• Work cross-functionally to conduct root cause analysis to understand the source of the deviation.
• In collaboration with the CIE, this individual will document the investigation, root cause analysis, and actions taken in comprehensive writeups to be reviewed by Quality and Operations Management.
• Fully competent and proficient on updated cGMP, industry standards, FDA regulations, and best practices in manufacturing and quality control.
• Work closely with the CIE to implement appropriate corrective and preventative actions for ODRs.
• Support other quality initiatives as needed and required.

Experience Required

• Bachelor’s degree in engineering, food science or related discipline is preferred.  Relevant experience (in infant formula manufacturing or food manufacturing) will be considered as a sufficient alternative to a degree. 
• Understanding of food safety principles, SOPs, cGMP, HACCP, regulatory requirements, and quality standards
• Demonstrated competent writing abilities.  Specific technical writing training will be administered while in role.
• Knowledge of Microsoft Office suite including Word, Excel and Powerpoint
• Effective communication skills and ability to work cross functionally.
• Demonstrated ability to work independently, manage multiple priorities, and meet deadlines.
• Demonstrated problem solving ability.
• Experience conducting complex investigations and application of appropriate investigation tools to determine root cause and appropriate CAPA is preferred.