Quality Assurance Change Control Lead - Flexible Work

Elanco; Elwood (KS); Vor Ort; USD 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Relocation packages

Parental leave

Employee Resource Groups

Annual bonus

Flexible work arrangements

401(k) matching

Zusammenfassung

Elanco in Elwood, KS is seeking a Quality Assurance Consultant, Change Control Coordinator to partner with Manufacturing, Process Teams, Warehouse, Facilities, Quality Control, and Quality Assurance. You will drive change controls, investigations, and QA systems activities while ensuring GMP compliance and timely closure across the site.

Responsibilities include leading CRB activities, overseeing daily change management, coaching teams, and contributing to continuous improvement initiatives.

Qualifikationen

• 8+ years of Quality Assurance experience within a regulated industry (FDA, USDA, ISO, etc.).
• 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.
• Experience with risk assessment tools and quality metrics reporting.

Aufgaben

• 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.

Kenntnisse

Change control

Root cause analysis

Quality documentation

MS Office

Ausbildung

Bachelor’s degree in a scientific discipline

Tools

eQMS

Jobbeschreibung

Elanco in Elwood, KS is seeking a Quality Assurance Consultant, Change Control Coordinator to partner with Manufacturing, Process Teams, Warehouse, Facilities, Quality Control, and Quality Assurance. You will drive change controls, investigations, and QA systems activities while ensuring GMP compliance and timely closure across the site.

Responsibilities include leading CRB activities, overseeing daily change management, coaching teams, and contributing to continuous improvement initiatives.