QA Consultant/Sr. Associate, Product Release & Responsible Person Delegate

Elanco; Kansas; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Relocation packages

Parental leave

Employee Resource Groups

Annual bonus

Flexible work arrangements

401K matching

Job summary

Elanco Elwood, KS is seeking a QA Consultant/Sr. Associate for Product Release & Responsible Person Delegate.

You will partner with QA leadership to audit products, ensure manufacturing, sampling and testing meet regulatory standards, and prepare Form 2008 submissions for USDA and GMP compliance. Responsibilities include batch record reviews, 2PV verifications, and acting as QA SME for internal project teams.

Qualifications

• Bachelor’s degree in a scientific discipline is required.
• Experience in manufacturing/quality with strong attention to detail.
• Knowledge of GMP/Regulatory requirements (US/EU).

Responsibilities

• Work with QA to ensure manufacturing, sampling and testing comply with regulations and Elanco standards.
• Perform batch record reviews, status notifications, stickering, and serial file reviews.
• Execute batch audits and final disposition for compliance to GMP/Outline requirements.
• Perform 2PV verifications for documents and submissions to Health Authorities.
• Serve as QA representative and delegate for the site Responsible Person on internal projects.

Skills

Batch audits

Product release

Regulatory knowledge

Two-person verification

Education

Bachelor’s degree in a scientific discipline

Job description

## QA Consultant/Sr. Associate, Product Release & Responsible Person DelegateApply: Elwood, KS: Full time: Posted Today: R0027745**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:** QA Consultant/Sr. Associate, Product Release & Responsible Person DelegateThis role for reports directly to the Director of QA. This individual will be responsible for auditing products for final disposition, and for ensuring all manufacturing, sampling, and testing activities comply with regulatory authority regulations/associated outlines of product/Elanco standards for the Elanco Elwood, KS site. From a product release function, 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. As a Responsible Person delegate, this position will ensure accuracy/completeness of submissions to Health Authorities, and ensure product quality and compliance with regulatory requirements for released batches.**Your Responsibilities:*** Work with the Quality Organization and other functions to ensure all manufacturing, sampling, and testing activities comply with regulatory authority regulations, associated outlines of production, and Elanco standards.* Perform batch record review, status notifications, assignment of stickering, and serial file reviews for in-process or product release.* Perform batch audits and final disposition for manufactured products for compliance to GMP/Outline to ensure products released comply with all requirements of relevant regulatory authorities, outlines of production, and elanco procedures.* Execute second person verifications (2PV) for documents and more generally submissions to Health Authorities* Serve as a QA representative and SME, and as a delegate for the site Responsible Person on assigned internal and external project/process flow teams to solve quality related issues**What You Need to Succeed (minimum qualifications):*** **Education**: Bachelor’s degree, preferably in a scientific discipline.* **Experience**: 5+ years of manufacturing and quality experience, preferably in a quality function.* Top 2 skills: Must be able to utilize all elements of the quality system to identify, classify, and control the status of finished products produced, and high attention to detail**What will give you a competitive edge (preferred qualifications):*** Technically self-sufficient and proficient in the performance of batch audits, product release, understanding of 9CFR and Form 2008 USDA submissions* Knowledge of pharmaceutical cGMPs (US and EU), FDA, USDA, VICH, and EU as related to manufacturing, quality, and release activities**Additional Information:*** Travel: 0%* Location: Elanco Elwood **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 statusElanco 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.