Quality Assurance Associate - Batch Release at Elanco in Fort Dodge, Iowa

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. 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: Quality Assurance Associate - Batch Release

This individual will be responsible for auditing products for final disposition for the Elanco Fort Dodge site. This position assures that all specifications and Outline of Production requirements are met prior to each stage of release leading up to Form 2008 submissions to comply with USDA, and GMP regulatory requirements. The scope of the support includes every state of manufacturing including products for 3rd party Contract Manufacturing.

Your Responsibilities:  

• Perform batch audits and final disposition for manufactured products for compliance to GMP, perform review and approval of executed batch records and/or test records, perform Impact assessments on products to comply with USDA or other GMP regulatory requirements, and perform form review and approval of APHIS Form 2008’s against applicable Outlines of Production for USDA 
  release.




• Review and approve Certificates of Analysis and Certificates of Compliance for batch release, review technical investigation reports, reference requalification, and optimization studies detailing findings, and review and approve local SOPs, Test Specifications, QC Methods, Special Outlines and Outline of Production.




• Create CBRs/International permits for international release 
  and product assessments.




• Ensure product documentation is complete and compliant with specifications, SOPs and regulations as well as submits product release data for monthly KPI and Metric reports.




• Serve as a QA representative and SME on assigned internal and external project/process flow teams, assist with audits to ensure compliance, and assist with audit responses and completion of assigned CAPAs by target due dates.

What You Need to Succeed (minimum qualifications): 

• Bachelor’s degree or equivalent level of experience

• Technically self-sufficient and proficient in the performance of batch audits and intermediate product release

What will give you a competitive edge (preferred qualifications): 

• Understanding of 9CFR and Form 2008 USDA submissions




• Good understanding of the relevant USDA regulations.




• Proficiency in relevant computer software programs associated with the area (Microsoft Suite, SAP, VEEVA, etc.)




• Ability to select, develop and assess the appropriateness of regulated processes and technical disciplines associated with the manufacture, testing, and verification of products manufactured by Elanco.

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Additional Information:  

• Location: Fort Dodge, IA

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 for eligible positions

• 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