Sr. Quality Assurance Specialist - Investigations & Compliance

Elanco; Elwood (IN); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Relocation packages

Parental leave

Employee Resource Groups

Annual bonus

Flexible work

401K matching

Job summary

Elanco, a global leader in animal health, is seeking a Sr. Quality Assurance Specialist - Investigations & Compliance to partner with Manufacturing, Warehouse, Facilities, and Quality teams.

You will drive investigations, root cause analysis, and CAPAs to ensure timely closure and adherence to GMP and regulatory expectations. In this role, you will lead or support DRB activities, communicate status across departments, and mentor teams to strengthen site quality and continuous improvement.

Qualifications

• Bachelor’s degree in a scientific discipline.
• 6+ years QA experience in a regulated industry.
• 5+ years investigating deviations and performing RCA.
• Experience reviewing GMP documents, investigations, and CAPAs.

Responsibilities

• Coordinate daily activities within the site deviation management system.
• Lead deviation investigations to timely, compliant closure.
• Facilitate or support Deviation Review Board (DRB) activities and cross-functional collaboration.
• Drive root cause analysis (RCA) using 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 and quality reviews.
• Provide technical review and guidance for investigations and quality records.

Skills

Investigation

Root cause analysis

Cross-functional leadership

GMP manufacturing

Education

Bachelor's degree in science

Tools

eQMS

MS Office

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 Specialist - Investigations & Compliance

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 (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

#LI-HL

#LI-Onsite

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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