Senior QA Change Control Lead — GMP & Cross-Functional

Farmer Veteran Coalition; Northern (KY); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Relocation packages

8-week parental leave

Annual bonus offering

Flexible work arrangements

6% 401K matching

Job summary

Elanco is seeking a Sr. Quality Assurance Associate – Change Control Coordinator to collaborate across Manufacturing, Process Teams, QA, and Facilities to manage site change controls and ensure GMP compliance. You will drive investigations, CAPA, and QA documentation quality within a regulated manufacturing environment.

The role emphasizes strong cross-functional collaboration, change control execution, and continuous improvement to maintain site quality standards and operational excellence.

Qualifications

• 8+ years of Quality Assurance experience in 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.
• Strong ability to independently manage cross-functional quality initiatives in a GMP-regulated environment.

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.

Skills

Change control

Root cause analysis

Education

Bachelor's degree in a scientific discipline

Tools

eQMS

Microsoft Office

Job description

Elanco is seeking a Sr. Quality Assurance Associate – Change Control Coordinator to collaborate across Manufacturing, Process Teams, QA, and Facilities to manage site change controls and ensure GMP compliance. You will drive investigations, CAPA, and QA documentation quality within a regulated manufacturing environment.

The role emphasizes strong cross-functional collaboration, change control execution, and continuous improvement to maintain site quality standards and operational excellence.