Quality Assurance Associate at Elanco in Elwood, Kansas

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!

Position Role:

The QA Associate, Product Release reports directly to the QA Manager. This individual will be responsible for auditing products for final disposition for the Elanco Elwood, KS 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 and serves as a QA representative and SME on assigned internal and external project/process flow teams to solve quality related issues.

Your Responsibilities:

• Responsible for control of official batch related records into and out of QA Department including: Performing batch record review, status notifications, assignment of stickering, and serial file reviews for in-process or product release, and batch audits and final disposition for manufactured products for compliance to GMP/Outline.


• Perform review and approval of executed records (Batch Records, Manufacturing Directions, Solution Records, Autoclave Records, Logbooks, QC Testing) and Certificates of Analysis and Certificates of Compliance for batch release.


• Perform Impact assessments on products to comply with USDA or other GMP regulatory requirements.


• Review and/or approve local SOPs, Test Specifications, Master Production Record Review, Special Outlines and Outlines of Production.


• Prepare, Review and/or Submit APHIS Form 2008’s against applicable Outlines of Production for USDA release.


• Ensure product documentation is complete and compliant with specifications, SOPs, and regulations.


• Submits product release data for monthly KPI and Metric reports.


• Assist with internal, regulatory, and corporate audits to ensure compliance with regulations, quality standards and guidance documents and follow up on audit responses and completion of assigned CAPAs by target due dates.


• Lead, mentor, and coach operations and support personnel on quality and good documentation matters.

What You Need to Succeed (Minimum Qualification):

• Bachelor’s degree in a scientific discipline (preferred) with 3+ years of quality experience.


• Technically self-sufficient and proficient in the performance of QA batch audits, product release in a USDA setting.


• Understanding of 9CFR.


• Proficient in submitting Form 2008 through the portal for product release.


• Knowledge of pharmaceutical cGMPs (US and EU), FDA, USDA, VICH, and EU as related to manufacturing, quality, and release activities.


• Must be able to utilize all elements of the quality system to identify, classify, and control the status of finished products produced.


• Knowledge and understanding of biopharmaceutical and pharmaceutical operations.


• Analytical Skills: Highly analytical and strong advocate for process improvement.


• Excellent written and verbal communication skills with internal and external customers, peers, and managers.


• Excellent computer, documentation, and organizational skills required.

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

• Experience in Operational Excellence and/or Investigation procedures.


• Experience in Materials Management for USDA or FDA regulated industries.


• Experience in Quality Control testing and environments.


• 5+ years’ experience in the Biotech / Pharmaceutical industry.


• Experience in tech transfer, optimization, and validation of analytical methods for characterization of biological products (e.g., mAbs, recombinant proteins, vaccines).


• Experience with SAP and Veeva Vault.


• Strong leadership, team building, organizational and interpersonal skills. High attention to detail.


• Working knowledge of VICH, USDA and/or EU GMP regulations for veterinary biologics.

Additional Information:

• This is considered an on-site position.


• Day shift position.  Weekend and evening work not usual, although may be required to provide process support to ongoing operations.

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:

Relocation packages

·       Two week shut downs (mid-summer and year-end) in the US (in addition to PTO)

·       10-week parental leave

·       9 Employee Resource Groups

·       Annual bonus offering

·       Flexible work arrangements

·       Up to 6% 401K matching

·       Dependent and childcare support

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