Quality Assurance Associate – Material Release

Elanco•Elwood, KS

1d•Onsite

About The Position

This position coordinates and performs activities within the Quality Assurance department related to material and printed packaging release, specifications management, and audit support. The role is responsible for ensuring materials meet quality and compliance standards prior to use, while supporting additional quality systems and continuous improvement initiatives. This position works closely with Manufacturing and Warehouse teams to ensure efficient and compliant material flow.

Requirements

Bachelor’s degree (or Master’s) in a Life Science discipline preferred, and/or a minimum of 3 years of experience in a regulated industry (USDA, FDA, ISO, etc.).
Direct experience in Quality Assurance within a regulated environment.
Strong understanding and application of GMP principles and global manufacturing regulations.

Nice To Haves

Experience with documentation review/approval, technical writing, and investigation writing.
Familiarity with quality risk management tools and basic statistical concepts.
Ability to manage multiple priorities and deadlines in a fast-paced environment.
Strong interpersonal and teamwork skills with the ability to collaborate effectively across functions.
Proven ability to make sound, independent decisions.

Responsibilities

Manage quality assurance activities for material movement, including disposition decisions such as release, hold, or rejection of incoming materials.
Own and maintain material and packaging specifications, including drafting, periodic review, and updates to ensure compliance with current standards.
Support internal and supplier audits, including participation, documentation, and follow-up activities.
Perform gap assessments for material, packaging, and labeling specifications, as well as Standard Operating Procedures, to identify compliance risks and improvement opportunities.
Initiate, draft, and manage quality system records including change controls, deviations, and CAPAs within the Veeva Quality Management System.
Participate in investigation teams, supporting root cause analysis, documentation, and timely closure of actions.
Author new quality documents and revise existing procedures to maintain compliance and operational effectiveness.
Lead or support QA-related projects with minimal supervision, managing priorities and delivering results independently while aligning with overall project direction.
Execute SAP transactions related to material release and verify accuracy of system data.