Senior QA Release & Compliance Lead

Kansas Ag Connection; United States; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Relocation packages

Parental leave

401K matching

Flexible work arrangements

Employee Resource Groups

Job summary

Elanco Elwood, KS is seeking a QA Consultant/Sr. Associate, Product Release & Responsible Person Delegate. You will audit products for final disposition and ensure manufacturing and testing comply with FDA/USDA GMP standards.

Responsibilities include batch records review, 2PV verifications, and acting as QA SME for site teams. A Bachelor's in science and 5+ years in quality manufacturing are desired, with travel at 0%.

Qualifications

• Bachelor's degree in a scientific discipline.
• 5+ years manufacturing and quality experience.
• Familiarity with 9CFR, Form 2008 USDA submissions, and GMP programs.

Responsibilities

• Audit products for final disposition and ensure compliance with regulatory requirements.
• Perform batch record review, status notifications, and serial file reviews.
• Execute 2PV verifications and support Health Authority submissions.
• Serve as QA SME and delegate for the Responsible Person at the site.

Skills

Quality system

Batch audits

Product release

2PV verification

Regulatory knowledge

Education

Bachelor's degree in science

Job description

Elanco Elwood, KS is seeking a QA Consultant/Sr. Associate, Product Release & Responsible Person Delegate. You will audit products for final disposition and ensure manufacturing and testing comply with FDA/USDA GMP standards.

Responsibilities include batch records review, 2PV verifications, and acting as QA SME for site teams. A Bachelor's in science and 5+ years in quality manufacturing are desired, with travel at 0%.