Senior QA Release Lead & Compliance Specialist

Elanco; Elwood (IN); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Relocation packages

9 Employee Resource Groups

Annual bonus offering

Flexible work arrangements

Up to 6% 401K matching

Job summary

Elanco is hiring a QA Consultant/Sr. Associate for Product Release & Responsible Person Delegate at the Elwood site. You will audit products for final disposition and ensure manufacturing, sampling, and testing meet regulatory requirements. You will lead release activities and ensure accurate Health Authority submissions.

Responsibilities include batch record reviews, 2PV verifications, and acting as QA SME on cross-functional teams to address quality issues. Travel is minimal.

Qualifications

• Education: Bachelor’s degree in a scientific discipline.
• Experience: 5+ years in manufacturing and quality, preferably in quality function.
• Top skills: use quality system elements to identify, classify, and control finished products; high attention to detail.

Responsibilities

• Collaborate with Quality Organization and other functions to ensure manufacturing, sampling, and testing comply with regulations and Elanco standards.
• Perform batch record review, status notifications, stickering, and serial file reviews for in-process or product release.
• Conduct batch audits and final disposition for manufactured products to ensure compliance with GMP and production outlines.
• Execute second person verifications (2PV) for documents and Health Authority submissions.
• Serve as QA representative and SME, and delegate for site Responsible Person on project/process teams to resolve quality issues.

Skills

Quality system knowledge

Attention to detail

Education

Bachelor’s degree in a scientific discipline

Job description

Elanco is hiring a QA Consultant/Sr. Associate for Product Release & Responsible Person Delegate at the Elwood site. You will audit products for final disposition and ensure manufacturing, sampling, and testing meet regulatory requirements. You will lead release activities and ensure accurate Health Authority submissions.

Responsibilities include batch record reviews, 2PV verifications, and acting as QA SME on cross-functional teams to address quality issues. Travel is minimal.