Sr. Quality Assurance Associate - Investigation Coordinator

As 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 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) activities 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

What You Need to Succeed (minimum qualifications):

Education: Bachelor’s degree in a scientific discipline preferred

Experience:

​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 CAPAs

Experience with risk assessment tools and quality metrics reporting

Top 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 skills

Experience with electronic Quality Management Systems (eQMS)

Demonstrated proficiency in Microsoft Office applications (Word, Excel, PowerPoint)

Ability to manage multiple priorities with strong organizational skills

Experience working collaboratively across manufacturing and quality functions

Strong coaching and mentorship capabilities

Experience within animal health or pharmaceutical manufacturing environments

Additional Information:

Travel: Occasional <10%

Location: Elwood, KS

The 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 packages

8-week parental leave

9 Employee Resource Groups

Annual bonus offering

Flexible work arrangements

Up to 6% 401K matching

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Elanco 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

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