Sr. Associate, Quality Assurance - CAPA Lead

Role Summary

Sr. Associate, Quality Assurance - CAPA Lead at Lilly. Oversees the site Deviation and CAPA program as part of the Quality Management System to ensure safe and effective products, regulatory compliance, and inspection readiness. Leads CAPA activities, drives product and process improvement, and mentors cross-functional teams.

Responsibilities

• Maintains responsibility for a safe work environment, leading safety initiatives, and working safely; accountable for supporting all Health, Safety, and Environmental Corporate and Site Goals.
• Leads, mentors, and coaches operations and support personnel on the deviation management system and CAPA program.
• Facilitates the Site Deviation and CAPA review board, providing board leadership to drive complete root cause investigations and ensure assignment of corrective and preventive actions to eliminate root causes and prevent reoccurrence.
• Create and maintain the CAPA program, cross-functionally with area/function owners to include data sources that identify existing and potential problems.
• Compile and present CAPA program health metrics to the Site Quality Lead Team with proposed actions.
• Monitor deviation and CAPA performance to ensure investigations and associated CAPA are completed in a timely manner.
• Act as a site instructor for Deviation Management courses.
• Coaches lead investigators on technical writing.
• Authors periodic reviews and acts as SME for site CAPA and Deviation Management procedures.
• Supports and initiates deviations, trends, or other technical investigations, as applicable.
• Engages site personnel in the relationship between the CAPA program and resulting product and process improvement and enhanced product and process understanding.
• Works with the network deviation program mentor to benchmark and replicate best practices.

Qualifications

• Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.
• Minimum 5 years in the pharmaceutical industry with specific deviation management and CAPA experience.
• On-site presence required.

Additional Skills

• Demonstrated understanding of cGMP regulations.
• Previous experience in GMP production environments.
• Demonstrated knowledge and use of US, EU, Japan and other regulations in pharmaceutical manufacturing.
• Proficiency with applicable computer systems.
• Strong oral and written communication skills.
• Interpersonal skills and the ability to work as a team.
• Root cause analysis/troubleshooting skills.
• Attention to detail and ability to maintain quality systems.
• Ability to work independently or as part of a team to resolve an issue.
• Technical writing and communication skills.
• Previous regulatory inspection readiness and inspection execution experience.

Education

• None beyond the Qualifications listed.

Additional Requirements

• Primary location is Kenosha County, Wisconsin.
• Ability to travel approximately 10%.
• Ability to work overtime as required.