Quality Assurance Associate - Supplier Management

Elanco•Elwood, KS

12d•Onsite

About The Position

At Elanco, a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. We pride ourselves on fostering a diverse and inclusive work environment, believing that diversity is the driving force behind innovation, creativity, and overall business success. This role supports quality and compliance activities at our Elwood, Kansas facility, focusing on material and packaging release, specification management, audit support, quality system records, and cross-functional collaboration to ensure compliance with regulatory and quality standards.

Requirements

Bachelor's degree in a Life Science discipline preferred, or equivalent combination of education and experience.
Minimum of 5 years of experience in a regulated industry (USDA, FDA, ISO, GMP, or similar) with direct Quality Assurance experience.
Strong understanding of quality systems, GMP principles, and applicable regulatory requirements.
Experience reviewing and approving quality documentation, investigations, deviations, CAPAs, and change controls.
Demonstrated ability to make sound independent decisions and manage multiple priorities simultaneously.
Strong technical writing, analytical, and problem-solving skills.
Excellent verbal and written communication skills.
Proficiency with Microsoft Office applications including Word, Excel, and PowerPoint.
Ability to work effectively in a collaborative team environment.

Nice To Haves

Bachelor's 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, and GMP requirements within pharmaceutical, biotechnology, or veterinary biologics manufacturing environments.
Demonstrated project management experience and ability to lead quality initiatives across functional teams.
Experience supporting continuous improvement and compliance-focused programs.

Responsibilities

Manage quality assurance activities related to 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, including drafting, annual review, and revision updates.
Conduct gap assessments for material, packaging, labeling specifications, and Standard Operating Procedures (SOPs).
Draft, route, and complete quality system records including change controls, deviations, CAPAs, and investigations within the Veeva Quality Management System.
Participate in and lead internal and supplier audits while supporting documentation requests for external regulatory audits.
Analyze quality events, investigations, and projects to determine appropriate actions and independently resolve complex technical and compliance issues.
Represent Quality Assurance on cross-functional project teams and provide quality guidance to support business objectives.
Author and revise quality documents, procedures, and records to maintain compliance with applicable regulations and internal standards.
Conduct SAP transactions to support material release activities and verify data accuracy within the system.
Support records management and archival activities while assisting other Quality Assurance team members as needed.