Senior QA Consultant — Product Release & Compliance (Flexible)

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 is seeking a QA Consultant/Sr. Associate in Elwood, KS, reporting to the Director of QA.

You will audit products for final disposition and ensure all manufacturing, sampling, and testing activities comply with regulatory requirements for USDA and GMP. As a Responsible Person delegate, you will ensure accuracy and completeness of submissions to Health Authorities and maintain product quality and compliance for released batches.

Qualifications

• Bachelor’s degree, preferably in a scientific discipline.
• 5+ years of manufacturing and quality experience, preferably in a quality function.
• Must be able to utilize all elements of the quality system to identify, classify, and control the status of finished products produced, and high attention to detail.

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 systems

Attention to detail

Regulatory knowledge

Education

Bachelor's degree

Job description

Elanco is seeking a QA Consultant/Sr. Associate in Elwood, KS, reporting to the Director of QA.

You will audit products for final disposition and ensure all manufacturing, sampling, and testing activities comply with regulatory requirements for USDA and GMP. As a Responsible Person delegate, you will ensure accuracy and completeness of submissions to Health Authorities and maintain product quality and compliance for released batches.