GMP Quality Assurance Change Control Lead

Elanco; Elwood (IN); Vor Ort; USD 110.000 - 140.000; Vollzeit

Benefits dieser Stelle

Multiple relocation packages

8-week parental leave

9 Employee Resource Groups

Annual bonus offering

Flexible work arrangements

Up to 6% 401K matching

Zusammenfassung

Elanco, a global leader in animal health, seeks a Quality Assurance Consultant, Change Control to partner across Manufacturing, Process Teams, and Quality to drive site change management. You will oversee change controls, investigations, CAPA, and QA documentation while ensuring GMP compliance and continuous improvement.

Ideal candidates bring 8+ years in QA within regulated settings, deep change control and RCA experience, and strong cross-functional collaboration skills to maintain high site

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

Quality systems

Cross-functional collaboration

Ausbildung

Bachelor's degree in a scientific discipline

Tools

eQMS

Microsoft Office

Jobbeschreibung

Elanco, a global leader in animal health, seeks a Quality Assurance Consultant, Change Control to partner across Manufacturing, Process Teams, and Quality to drive site change management. You will oversee change controls, investigations, CAPA, and QA documentation while ensuring GMP compliance and continuous improvement.

Ideal candidates bring 8+ years in QA within regulated settings, deep change control and RCA experience, and strong cross-functional collaboration skills to maintain high site