Quality Assurance Associate - Supplier Management
Elanco
Your Role: Quality Assurance Associate - Supplier Management
Responsibilities:
- Manage quality assurance activities related to material movement (disposition, hold, rejection, release of incoming materials).
- Support Manufacturing and Warehouse teams 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 to determine actions 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 and verify data accuracy.
- Support records management/archival and assist QA team members as needed.
What You Need to Succeed (minimum qualifications):
- Bachelorβs 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.
- Technical writing, analytical, and problem-solving skills.
- Excellent verbal and written communication.
- Proficiency with Microsoft Office (Word, Excel, PowerPoint).
- Ability to work effectively in a collaborative team environment.
What Will Give You a Competitive Edge (preferred qualifications):
- Degree in Biology, Microbiology, Chemistry, Biochemistry, or another Life Science field.
- Experience with Veeva Quality Management Systems and SAP.
- Knowledge of risk management tools and basic statistical analysis.
- Experience conducting supplier, internal, and regulatory audits.
- Familiarity with USDA/FDA/ISO/GMP requirements in pharmaceutical/biotech/veterinary biologics environments.
- Project management experience; led quality initiatives across functional teams.
- Experience supporting continuous improvement and compliance-focused programs.
Benefits (highlights):
- Multiple relocation packages; 8-week parental leave; 9 Employee Resource Groups; annual bonus; flexible work arrangements; up to 6% 401(k) matching.
Additional Information:
- Travel: 0β5%; Location: Elwood, Kansas; 24/7 Manufacturing Facility.