Quality Assurance Associate - Supplier Management
Elanco
August 08, 2026
On-site
Elwood, KS
Operations
Quality Assurance Associate - Supplier Management
Responsibilities:
- Manage quality assurance activities for material movement, including disposition, hold, rejection, and release of incoming materials.
- Support Manufacturing and Warehouse teams by promoting compliance through leadership, collaboration, and day-to-day quality oversight.
- Own the lifecycle management of material and packaging specifications (drafting, annual review, revision updates).
- Conduct gap assessments for material, packaging, labeling specifications, and SOPs.
- Draft, route, and complete quality system records (change controls, deviations, CAPAs, investigations) within the Veeva Quality Management System.
- Participate in and lead internal and supplier audits; support documentation requests for external regulatory audits.
- Analyze quality events/investigations/projects and resolve complex technical and compliance issues.
- Represent Quality Assurance on cross-functional project teams and provide quality guidance.
- Author and revise quality documents, procedures, and records to maintain compliance.
- Conduct SAP transactions to support material release activities and verify data accuracy.
- Support records management and archival; assist other QA team members as needed.
Qualifications (Minimum):
- Bachelor’s degree in a Life Science discipline preferred (or equivalent education/experience).
- 5+ years in a regulated industry (USDA, FDA, ISO, GMP, or similar) with direct Quality Assurance experience.
- Strong understanding of quality systems, GMP principles, and regulatory requirements.
- Experience reviewing/approving quality documentation, investigations, deviations, CAPAs, and change controls.
- Ability to make independent decisions and manage multiple priorities.
- Strong technical writing, analytical, and problem-solving skills.
- Excellent verbal and written communication.
- Microsoft Office proficiency (Word, Excel, PowerPoint).
- Ability to work collaboratively.
Preferred:
- Experience with Veeva Quality Management Systems and SAP.
- Audit experience (supplier/internal/regulatory) and risk/statistics knowledge.
- Familiarity with USDA/FDA/ISO/GMP in pharmaceutical/biotech/veterinary biologics environments.
Additional Information:
- Location: Elwood, Kansas; Travel: 0–5%; 24/7 Manufacturing Facility.
Responsibilities:
- Manage quality assurance activities for material movement, including disposition, hold, rejection, and release of incoming materials.
- Support Manufacturing and Warehouse teams by promoting compliance through leadership, collaboration, and day-to-day quality oversight.
- Own the lifecycle management of material and packaging specifications (drafting, annual review, revision updates).
- Conduct gap assessments for material, packaging, labeling specifications, and SOPs.
- Draft, route, and complete quality system records (change controls, deviations, CAPAs, investigations) within the Veeva Quality Management System.
- Participate in and lead internal and supplier audits; support documentation requests for external regulatory audits.
- Analyze quality events/investigations/projects and resolve complex technical and compliance issues.
- Represent Quality Assurance on cross-functional project teams and provide quality guidance.
- Author and revise quality documents, procedures, and records to maintain compliance.
- Conduct SAP transactions to support material release activities and verify data accuracy.
- Support records management and archival; assist other QA team members as needed.
Qualifications (Minimum):
- Bachelor’s degree in a Life Science discipline preferred (or equivalent education/experience).
- 5+ years in a regulated industry (USDA, FDA, ISO, GMP, or similar) with direct Quality Assurance experience.
- Strong understanding of quality systems, GMP principles, and regulatory requirements.
- Experience reviewing/approving quality documentation, investigations, deviations, CAPAs, and change controls.
- Ability to make independent decisions and manage multiple priorities.
- Strong technical writing, analytical, and problem-solving skills.
- Excellent verbal and written communication.
- Microsoft Office proficiency (Word, Excel, PowerPoint).
- Ability to work collaboratively.
Preferred:
- Experience with Veeva Quality Management Systems and SAP.
- Audit experience (supplier/internal/regulatory) and risk/statistics knowledge.
- Familiarity with USDA/FDA/ISO/GMP in pharmaceutical/biotech/veterinary biologics environments.
Additional Information:
- Location: Elwood, Kansas; Travel: 0–5%; 24/7 Manufacturing Facility.