Senior QA Consultant: Product Release & Compliance

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

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.