QA Consultant/Sr. Associate, Product Release & Responsible Person Delegate

United States·Elwoodsenior

Other

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Quick Summary

Key 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,

Requirements Summary

Work with the Quality Organization and other functions to ensure all manufacturing, sampling, and testing activities comply

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Requirements

~1 min read

Education: Bachelor’s degree, preferably in a scientific discipline.
Experience: 5+ years of manufacturing and quality experience, preferably in a quality function.
Top 2 skills: 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

Technically self-sufficient and proficient in the performance of batch audits, product release, understanding of 9CFR and Form 2008 USDA submissions
Knowledge of pharmaceutical cGMPs (US and EU), FDA, USDA, VICH, and EU as related to manufacturing, quality, and release activities

Responsibilities

~1 min read

→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

Travel: 0%
Location: Elanco Elwood

What We Offer

~1 min read

We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:

✓Multiple relocation packages

✓8-week parental leave

✓9 Employee Resource Groups

✓Annual bonus offering

✓Flexible work arrangements

✓Up to 6% 401K matching