QA Change Control Lead — GMP Compliance & Improvement

Farmer Veteran Coalition

Kansas

On-site

USD 85,000 - 120,000

Full time

9 days ago

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Benefits offered by this job

Relocation packages
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
401K matching
LI-HL
LI-Onsite

Job summary

Elanco is seeking a Quality Assurance Consultant, Change Control at its Elwood, KS site. You will partner with Manufacturing, Process Teams, Warehouse, Facilities, Quality Control and QA to oversee the site change management process and ensure GMP compliance.

Responsibilities include leading CRB activities, driving timely closure of change controls, supporting deviations and RCA, and maintaining QA documentation and procedures while contributing to audits and continuous improvement initiatives.

Qualifications

  • 8+ years of Quality Assurance experience within a regulated industry (FDA, USDA, ISO).
  • 6+ years with change control systems and RCA tools (5 Whys, Ishikawa/6M).
  • Experience reviewing GMP documentation, investigations and change controls.
  • Experience with risk assessment tools and quality metrics reporting.

Responsibilities

  • Coordinate and oversee daily activities within the site change management system.
  • Lead or support Change Review Board 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 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.
  • Participate in audits, inspection readiness activities, and continuous improvement initiatives.
  • Manage QA projects independently with minimal oversight.
  • Support a strong quality culture through coaching and collaboration.

Skills

Change control
Root cause analysis

Education

Bachelor's degree

Tools

eQMS
Microsoft Office

Job description

Elanco is seeking a Quality Assurance Consultant, Change Control at its Elwood, KS site. You will partner with Manufacturing, Process Teams, Warehouse, Facilities, Quality Control and QA to oversee the site change management process and ensure GMP compliance.

Responsibilities include leading CRB activities, driving timely closure of change controls, supporting deviations and RCA, and maintaining QA documentation and procedures while contributing to audits and continuous improvement initiatives.

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