Quality Auditor - Scientific - I

Join a specialized and dynamic Quality Assurance team in Elkhorn, NE as a QA Contractor supporting animal health manufacturing operations. In this role, you will play a critical part in ensuring quality and compliance, primarily focusing on the detailed review and batch record release of completed production documents across multiple departments. Operating in a clean manufacturing facility, you will bridge office-based compliance work with hands-on engagement in manufacturing areas, collaborating closely with Upstream and Downstream Integrated Process Teams (IPTs), QA colleagues, and regulatory inspectors. We are looking for a detail-oriented, organized professional with strong critical thinking, problem-solving skills, and disciplined judgment who thrives in a collaborative environment where Safety and Quality are primary values.

Responsibilities

• Review completed production batch documents across multiple departments to support ongoing manufacturing operations and batch releases.
• Track and prioritize document reviews based on target release dates, providing regular review status updates to both upstream and downstream teams.
• Provide documentation guidance from a quality compliance perspective, leveraging knowledge of cGMP, local and global Animal Health standards, and USDA regulations.
• Support raw material and printed packaging material reviews and releases.
• Maintain detailed focus while reviewing paper batch records for significant portions of the workday and assist with document archival tasks.
• Work closely with Upstream and Downstream IPTs and QA leadership to assist with investigations, compliance actions, and regulatory or off-site agency inspections.
• Spend approximately 20% of the time in manufacturing areas to learn processes, evaluate compliance, and build strong relationships of trust with production operators and management.
• Serve as a backup for various Quality Assurance functions and systems, seeking opportunities to cross-train across the QA team.
• Manage short-term tasks, special projects, and other duties as assigned by the QA Manager and Quality Director with high organization and agility.
• Balance operational perspectives across Planning, QA, and Production using strong leadership behaviors and principles of inclusion.

Education

• Minimum Requirement: High School Diploma (or equivalent).
• Preferred Requirement: Bachelor’s degree in Microbiology, Chemistry, or a similar scientific discipline.

Experience

• Minimum Requirement: High School Diploma with a minimum of 3 years of general work history OR 1 year of experience in a similar industry.
• Preferred Experience & Skills:
• Familiarity and/or experience with vaccine manufacturing and testing.
• Experience with USDA and/or FDA regulations, standards, and inspections.
• Hands-on experience with cGMP and Quality Management Systems (QMS).
• Familiarity and/or experience with SAP or similar enterprise software systems.

Additional Information

• Work Location: Elkhorn, NE (On-site; primarily office setting ~80%, with regular presence in clean manufacturing areas ~20%).
• Shift Schedule: First Shift (Flexible start time between 6:30 AM and 8:00 AM CST).