Job Description

We are a growing Animal Health company that specializes in the manufacture of biologics and nutrition solutions. Our product portfolio is expanding and we are looking for an experienced Quality Assurance Manager with good experience working in a USDA regulated, pharmaceutical environment.

The successful candidate is passionate about developing their team, has strong supervisory or management experience in quality assurance, and in-depth knowledge of USDA regulatory guidelines and submission protocols. This individual is strategic, with good experience at high-level project management and communication.

Located in Lincoln, Nebraska, we offer the opportunity to make every day a success story and put your mark on our company. We offer excellent benefits, salary in the range of $80k to $110k plus substantial bonus!

Responsibilities:

• Ensure compliance with applicable USDA requirements for licensed facilities for release and distribution of products and pre-license projects.
• Provide leadership during USDA inspections.
• Drive QA activities related to projects, quality systems and product release.
• Review CVB submissions and manage review of change controls and new documents.
• Manage quality training for QA team and develop QA individuals toward successful career paths.
• Assist in writing and maintaining client quality agreements or quality manuals.
• Conduct risk assessments, root cause analyses and continuous improvement initiatives to identify and address quality-related issues and deviations.
• Perform complex compliance problem solving issues and assist team with problem solving as needed.

Requirements:

• 3 to 4 years of supervisory/managerial experience in QA
• Bachelor’s degree in Microbiology, Biology, immunology or related field with 8 years of experience in pharma, USDA or related industry OR Master’s with 4 years of same experience
• Experience working in a USDA or FDA regulated environment
• Experience with guidance documents pertaining to veterinary biologics
• Ability to travel in the U.S. up to 7 times per year

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