Specialist, Quality Assurance

Job Description

Join Us in Shaping the Future of Animal Health

Our company's Animal Health is investing $895 million in expanding our manufacturing and research & development facilities in De Soto, Kansas — the state’s largest economic development project to date.

We are seeking a Quality Assurance (QA) Specialist to support the site expansion project and ensure quality systems and day-to-day quality activities are executed to meet USDA regulatory requirements and the compnay's Animal Health Quality Manual. The QA Specialist will execute, document, and help optimize quality processes during the build-out and qualification phases and support handover to operations.

As a Specialist in QA, you will be part of a world-class team at our Center of Excellence in the Animal Health Corridor, contributing directly to the production of veterinary products that improve animal health and welfare globally.

Key Responsibilities

• Execute quality system activities tied to the site expansion project, ensuring all tasks meet USDA regulations and company policies.

Support development, review, and controlled release of project-related quality documentation, including but not limited to:

• Standard Operating Procedures (SOPs)

• Batch records and supporting documents

• Validation and qualification protocols and reports (IQ/OQ/PQ as applicable)

• Risk assessments, and mitigation/corrective action plans

• Quality forms, logs, and templates needed for operations

Participate in development and execution of validation/verification activities for new/modified processes, equipment, utilities, and facility areas:

• Assist in developing, reviewing, and approving test protocols and qualification and validation reports

• Document discrepancies and deviations and support root cause analysis and CAPA implementation

• Conduct self-inspections, walk-throughs, and pre-operational checks to confirm compliance with USDA, company quality manual, and site requirements

• Support supplier/vendor quality management activities as they relate to equipment, materials, and service providers for the expansion

• Assist training new team members and preparing quality training materials and deliver or coordinate quality-related training for operations and project staff

• Maintain quality records and ensure document control during project activities; ensure traceability and readiness for regulatory review/inspection

• Monitor and report on quality metrics, project status, and risks; escalate issues to Quality Manager or project leadership as appropriate

• Facilitate cross-functional coordination (Engineering, Operations, EHS, Regulatory Affairs, Project Management) to ensure quality requirements are incorporated into design, installation, and start-up planning

• Support pre-commissioning and start-up activities, including initial production runs or trial lots, ensuring sampling, testing, and release procedures are followed

• Participate in regulatory inspections and assist in responses to findings or observations

• Contribute to continuous improvement initiatives to strengthen site quality systems post-expansion

Required Education/Experience:

• Bachelor’s degree in Biology, Microbiology, Chemistry, Animal Science, Quality Management, or related technical discipline required.

• 3+ years’ experience in quality assurance in USDA-regulated animal product facilities and USDA regulations and inspection processes in manufacturing environments, or equivalent regulated industry (experience during capital/expansion projects is a strong plus).

• Relevant practical experience with GMP complaince, batch release, change management, supplier quality management, qualification, and validation.

• Experience in document control, SOP creation, audit execution, and deviation management.

• Strong attention to detail, excellent documentation practices, and ability to maintain audit-ready records.

• Effective communication and interpersonal skills; ability to collaborate with cross-functional teams and external vendors.

• Proficient with MS Office (Word, Excel, PowerPoint); experience with electronic quality management systems (Reliance, Trackwise) or document management systems preferred.

What We’re Looking For

We seek individuals who:

• Demonstrate execution excellence through effective problem-solving and critical thinking.

• Embrace an entrepreneurial mindset, taking initi