Quality Assurance Associate - Technical Investigator

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. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

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:

This position coordinates and conducts activities of the Quality Assurance Department regarding deviation investigation support. This position is expected to work independently to drive deviation investigations to closure in a timely manner. This position also has responsibilities for other quality and compliance related activities as directed by the Quality Assurance Manager. This position works closely with Manufacturing, Warehouse, Facilities, Quality Control etc.

Your Responsibilities:

• Lead or assist staff for site level deviations within the deviation management system.
• Communicate interdepartmentally on the status of investigations to achieve results, meet timelines, and improve processes.
• Provide leadership and coaching to drive root cause analysis (RCA). Facilitate cross functional teams to evaluate causal factors.
• Ensure adequate CAPAs are identified to eliminate or reduce recurrence of deviations.
• Lead or assist investigations of customer complaints.
• Assist the Quality Manager with change control impact assessments and reviews.
• Lead or assist facilitation of the site Quality Review Board (QRB).

What You Need to Succeed (Minimum Qualifications):

• Education: BA/BS (or Master's) in any Life Science discipline preferred
• Required Experience: 5 years’ experience with Quality Assurance within a regulated industry (USDA, FDA, ISO etc).
• Understands and applies comprehensive knowledge of quality and GMP principles and maintains current understanding of global GMP manufacturing regulations.
• Minimum 3 years’ experience with root cause analysis tools (including 5 Whys, Ishikawa/6M, etc.) with demonstrated success.
• Familiarity or experience with the following is strongly preferred: Basic statistics, review/approval of documentation; risk tools, technical writing, and writing/reviewing/approving investigations.

Additional Information:

• Travel: Minimal, less than 5%
• Location: Elwood, KS (Onsite)

Don’t meet every single requirement? Studies have shown underrepresented 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
• Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
• 8-week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Flexible work arrangements
• Up to 6% 401K matching

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