Quality Assurance Associate - Change Control CoordinatorElanco • Elwood, New York, United States

Quality Assurance Associate - Change Control Coordinator

Elanco

Elwood, New York, United States

Elwood, New York, United States

Über

Quality Assurance Associate – Change Control Coordinator As the Quality Assurance Associate – Change Control Coordinator at Elanco, you will partner cross‑functionally with Manufacturing, Process Teams, Warehouse, Facilities, Quality Control, and Quality Assurance to support and oversee the site change management process. You will help drive change controls, investigations, and quality systems activities to timely closure while ensuring compliance with GMP and regulatory expectations. Responsibilities Coordinate and oversee daily activities within the site change management system. Lead or support Change Review Board (CRB) activities and facilitate cross‑functional collaboration. Drive change controls to closure in a timely and compliant manner. Communicate status updates and timelines across departments to support operational alignment. Support deviation investigations, including root cause analysis (RCA) and CAPA development. Provide technical review and guidance for quality documentation, investigations, and change controls. Write, revise, and maintain QA procedures and controlled documents. Support site quality metrics related to change management and identify trends as applicable. Participate in audits, inspection readiness activities, and continuous improvement initiatives. Manage QA projects independently with minimal oversight. Support a strong quality culture through coaching, collaboration, and technical guidance. Minimum Qualifications Bachelor’s degree in a scientific discipline. 8 years of Quality Assurance experience within a regulated industry (FDA, USDA, ISO, etc.). Strong expertise in change control and root cause analysis, combined with the ability to independently manage cross‑functional quality initiatives in a GMP‑regulated environment. Preferred Qualifications 6+ years of experience with change control systems and RCA tools (5 Whys, Ishikawa/6M, etc.). Experience reviewing and approving GMP documentation, investigations, and change controls. Strong technical writing and communication skills. Experience with risk assessment tools and quality metrics reporting. Experience with electronic Quality Management Systems (eQMS). Demonstrated proficiency in Microsoft Office applications (Word, Excel, PowerPoint). Ability to manage multiple priorities with strong organizational skills. Experience working collaboratively across manufacturing and quality functions. Strong coaching and mentorship capabilities. Additional Information Travel: Occasional Location: Elwood, KS. Role may occasionally require support outside of normal business hours to meet operational or compliance needs. Benefits Multiple relocation packages. 8‑week parental leave. 9 Employee Resource Groups. Annual bonus offering. Flexible work arrangements. Up to 6% 401(k) matching. Elanco is an Equal Employment Opportunity/affirmative action employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Elanco may use automated tools, including AI, to support parts of our recruitment process. All decisions involve a human reviewer.
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Elwood, New York, United States

Sprachkenntnisse

English

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