Senior QA Investigator: Deviation & RCA, Flexible Work

Farmer Veteran Coalition; Kansas; Hybrid; USD 95,000 - 125,000; Full time

Benefits offered by this job

Relocation packages

8-week parental leave

Employee Resource Groups

Annual bonus offering

Flexible work arrangements

Up to 6% 401K matching

Job summary

Elanco in Elwood, KS seeks a Sr. Quality Assurance Associate – Investigation Coordinator to oversee site deviation management, investigate quality events, and coordinate DRB activities. The role requires leading RCA efforts, documenting CAPAs, and ensuring regulatory compliance.

The incumbent will strengthen collaboration across manufacturing and quality functions, write and review QA procedures, and contribute to safety and quality culture while traveling occasionally.

Qualifications

• Bachelor's degree in a scientific discipline required or preferred.
• 6+ years of Quality Assurance experience in a regulated industry (FDA/USDA/ISO).
• 5+ years of investigations, deviation management, and RCA tools experience.
• Experience reviewing GMP documentation, investigations, and CAPAs; proficiency with quality metrics.

Responsibilities

• Coordinate daily activities within the site deviation management system.
• Lead deviation investigations to timely, compliant closure.
• Support Deviation Review Board (DRB) activities and cross-functional collaboration.
• Perform or coach root cause analysis using 5 Whys, Ishikawa/6M.

Skills

Investigation & RCA

Cross-functional collaboration

Quality culture coaching

Education

Bachelor's degree in a scientific discipline

Tools

eQMS

Job description

At Elanco (NYSE: ELAN) – it all starts with animals!As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.
At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.Making animals' lives better makes life better – join our team today!Your Role: Sr. Quality Assurance Associate – Investigation CoordinatorAs the Sr. Quality Assurance Associate – Investigation Coordinator, you'll partner cross-functionally with Manufacturing, Warehouse, Facilities, Quality Control, and Quality Assurance teams to support and oversee the site deviation and investigation management processes. You'll help drive investigations, root cause analysis, and corrective actions to timely closure while ensuring compliance with GMP and regulatory expectations. This role serves as a key partner in maintaining site quality standards, supporting continuous improvement initiatives, and strengthening operational compliance across the facility.Your Responsibilities:Coordinate and oversee daily activities within the site deviation management systemLead and support deviation investigations to timely and compliant closureFacilitate or support Deviation Review Board (DRB) activities and cross-functional collaborationDrive and coach root cause analysis (RCA) activities using tools such as 5 Whys and Ishikawa/6MEnsure appropriate CAPAs are identified and implemented to reduce recurrence of deviationsCommunicate investigation status updates and timelines across departmentsLead or assist customer complaint investigations as neededSupport site change controls, including impact assessments and quality reviewsProvide technical review and guidance for investigations, documentation, and quality recordsWrite, revise, and maintain QA procedures and controlled documentsSupport site quality metrics related to deviations, investigations, and complaint managementIdentify trends and support continuous improvement initiativesPromote a strong safety and quality culture through collaboration, mentorship, and technical coachingWhat You Need to Succeed (minimum qualifications):Education: Bachelor's degree in a scientific discipline preferredExperience: 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, etc.)Experience reviewing and approving GMP documentation, investigations, and CAPAsExperience with risk assessment tools and quality metrics reportingTop 2 Skills: Strong investigation and root cause analysis expertise combined with the ability to independently manage cross-functional quality initiatives in a GMP-regulated manufacturing environment.What Will Give You a Competitive Edge (preferred qualifications):Strong technical writing and communication skillsExperience with electronic Quality Management Systems (eQMS)Demonstrated proficiency in Microsoft Office applications (Word, Excel, PowerPoint)Ability to manage multiple priorities with strong organizational skillsExperience working collaboratively across manufacturing and quality functionsStrong coaching and mentorship capabilitiesExperience within animal health or pharmaceutical manufacturing environmentsAdditional Information:Travel: Occasional Location: Elwood, KSThe Elwood manufacturing facility is a 24/7/365 operation. This role primarily supports standard business hours but may occasionally require off-hour support to meet operational or compliance needs.Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!Elanco Benefits and Perks:We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:Multiple relocation packages8-week parental leave9 Employee Resource GroupsAnnual bonus offeringFlexible work arrangementsUp to 6% 401K matching#LI-HL#LI-OnsiteElanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.