Ensuring the integrity, compliance, and release readiness of incoming materials and packaging components for Elanco, a global leader in animal health
Requirements
- Deep understanding of GMP principles and supplier/material quality processes
- Experience with supplier qualification programs and external quality audits
- Familiarity with USDA and FDA regulatory frameworks for manufacturing environments
- Proficiency in drafting and managing quality agreements and technical documentation
- Working knowledge of risk assessment tools and CAPA/investigation workflows
- Hands-on experience with Veeva QMS and SAP material management
Responsibilities
- Manage the release, hold, and rejection of materials and packaging for production use
- Lead and support supplier qualification and audit activities, including documentation and follow-up
- Maintain and revise quality agreements, specifications, and controlled documents
- Perform quality risk assessments and gap analyses for materials and processes
- Support GMP compliance efforts and regulatory inspection readiness across the facility
Other
- Bachelor’s degree in Life Sciences preferred, or High School Diploma/GED with equivalent experience
- Minimum of 5 years in a regulated industry (USDA, FDA, ISO, etc.) with direct Quality Assurance experience
- Strong communication and decision-making abilities
- Ability to work in a diverse and inclusive work environment
- Location: Elwood, KS, with a Monday-Friday, 8-Hour Shift schedule
