Quality Assurance Associate – Investigation Coordinator
Elanco
August 23, 2026
On-site
Elwood, KS
Operations
Quality Assurance Associate – Investigation Coordinator
Responsibilities:
- Coordinate and oversee daily activities within the site deviation management system
- Lead and support deviation investigations to timely and compliant closure
- Facilitate/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 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
Minimum qualifications:
- Bachelor’s degree in a scientific discipline (preferred)
- 6 years of Quality Assurance experience in a regulated industry (FDA, USDA, ISO, etc.)
- Strong investigation and root cause analysis expertise; ability to independently manage cross-functional quality initiatives in a GMP-regulated manufacturing environment
Preferred qualifications:
- 5+ years with investigations, deviation management, and RCA tools (5 Whys, Ishikawa/6M)
- Experience reviewing/approving GMP documentation, investigations, and CAPAs
- Strong technical writing/communication skills
- Experience with risk assessment tools and quality metrics reporting
- Experience with eQMS; proficiency with Microsoft Office (Word, Excel, PowerPoint)
- Strong organizational skills, coaching/mentorship, and experience in animal health or pharmaceutical manufacturing
Benefits:
- Multiple relocation packages; 8-week parental leave; annual bonus offering; flexible work arrangements; up to 6% 401K matching
Application instructions:
- Apply for the role.
Responsibilities:
- Coordinate and oversee daily activities within the site deviation management system
- Lead and support deviation investigations to timely and compliant closure
- Facilitate/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 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
Minimum qualifications:
- Bachelor’s degree in a scientific discipline (preferred)
- 6 years of Quality Assurance experience in a regulated industry (FDA, USDA, ISO, etc.)
- Strong investigation and root cause analysis expertise; ability to independently manage cross-functional quality initiatives in a GMP-regulated manufacturing environment
Preferred qualifications:
- 5+ years with investigations, deviation management, and RCA tools (5 Whys, Ishikawa/6M)
- Experience reviewing/approving GMP documentation, investigations, and CAPAs
- Strong technical writing/communication skills
- Experience with risk assessment tools and quality metrics reporting
- Experience with eQMS; proficiency with Microsoft Office (Word, Excel, PowerPoint)
- Strong organizational skills, coaching/mentorship, and experience in animal health or pharmaceutical manufacturing
Benefits:
- Multiple relocation packages; 8-week parental leave; annual bonus offering; flexible work arrangements; up to 6% 401K matching
Application instructions:
- Apply for the role.