Senior QA Release Specialist – GMP & Regulatory Compliance

Elanco; Elwood (KS); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Multiple relocation packages

8-week parental leave

9 Employee Resource Groups

Annual bonus offering

Flexible work arrangements

Up to 6% 401K matching

Job summary

Elanco in Elwood, KS is seeking a QA professional to audit products for final disposition and ensure all manufacturing, sampling, and testing activities comply with regulatory standards. You will verify specifications and production outlines prior to release and support USDA/GMP submissions.

As a QA SME and site delegate for the Responsible Person, you will perform batch reviews, 2PV verifications, and collaborate with cross‑functional teams to resolve quality issues and maintain compliance

Qualifications

• Bachelor’s degree in a scientific discipline.
• 5+ years of manufacturing and quality experience.
• Strong attention to detail and understanding of quality systems.

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

Skills

Quality system

Attention to detail

Education

Bachelor’s degree

Job description

Elanco in Elwood, KS is seeking a QA professional to audit products for final disposition and ensure all manufacturing, sampling, and testing activities comply with regulatory standards. You will verify specifications and production outlines prior to release and support USDA/GMP submissions.

As a QA SME and site delegate for the Responsible Person, you will perform batch reviews, 2PV verifications, and collaborate with cross‑functional teams to resolve quality issues and maintain compliance