Sr. Quality Assurance Specialist - Investigations & Compliance

Your Role

As the Sr. Quality Assurance Specialist - Investigations & Compliance, 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

• 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.

Additional information

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

• #LI-HL
• #LI-Onsite

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.