Senior QA: Investigations & Compliance Leader (GMP)

Farmer Veteran Coalition; Kansas; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Relocation packages

Parental leave

Annual bonus

Flexible work arrangements

401K matching

Job summary

Elanco in Elwood, KS, is seeking a Sr. Quality Assurance Specialist – Investigations & Compliance.

You will partner with Manufacturing, Quality, and Facilities to oversee deviation management, root cause analysis, and CAPA implementation, ensuring GMP compliance across the site. You will drive investigations, support DRB activities, and coach teams in RCA techniques while contributing to continuous improvement and quality metrics.

Qualifications

• Bachelor's degree in a scientific discipline preferred.
• 6+ years of Quality Assurance experience within a regulated industry (FDA, USDA, ISO, etc.).
• 5+ years of experience with investigations, deviation management, and RCA tools (5 Whys, Ishikawa/6M).
• Experience reviewing and approving GMP documentation, investigations, and CAPAs.
• Experience with risk assessment tools and quality metrics reporting.

Responsibilities

• Coordinate and oversee daily activities within the site deviation management system.
• Lead and support deviation investigations to timely and compliant closure.
• Facilitate or support Deviation Review Board (DRB) activities and cross-functional collaboration.
• Drive and coach root cause analysis (RCA) using tools such as 5 Whys and Ishikawa/6M.
• Ensure appropriate CAPAs are identified and implemented to reduce recurrence of deviations.
• Communicate investigation status updates and timelines across departments.
• Lead or assist customer complaint investigations as needed.
• Support site change controls, including impact assessments and quality reviews.
• Provide technical review and guidance for investigations, documentation, and quality records.
• Write, revise, and maintain QA procedures and controlled documents.
• Support site quality metrics related to deviations, investigations, and complaint management.
• Identify trends and support continuous improvement initiatives.
• Promote a strong safety and quality culture through collaboration, mentorship, and technical coaching.

Skills

Investigation expertise

Root cause analysis

Cross-functional collab

Quality leadership

Education

Bachelor's degree in science

Tools

eQMS

MS Office

Job description

Elanco in Elwood, KS, is seeking a Sr. Quality Assurance Specialist – Investigations & Compliance.

You will partner with Manufacturing, Quality, and Facilities to oversee deviation management, root cause analysis, and CAPA implementation, ensuring GMP compliance across the site. You will drive investigations, support DRB activities, and coach teams in RCA techniques while contributing to continuous improvement and quality metrics.