Senior QA Release Consultant — Product Compliance & Release

Elanco US; Elwood (KS); 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 in Kansas seeks a QA Consultant/Sr. Associate in Product Release to ensure batch compliance and final disposition, auditing manufacturing, sampling, and testing against Elanco standards and regulatory guidelines.

Reporting to the Director of QA, you will manage submissions to Health Authorities, perform 2PV verifications, and serve as SME and site delegate on project teams, ensuring product quality and regulatory readiness.

Qualifications

• Bachelor's degree in a scientific discipline.
• 5+ years of manufacturing and quality experience.
• Strong attention to detail and ability to use the quality system to identify, classify, and control finished products.

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 Kansas seeks a QA Consultant/Sr. Associate in Product Release to ensure batch compliance and final disposition, auditing manufacturing, sampling, and testing against Elanco standards and regulatory guidelines.

Reporting to the Director of QA, you will manage submissions to Health Authorities, perform 2PV verifications, and serve as SME and site delegate on project teams, ensuring product quality and regulatory readiness.