Quality Assurance Specialist I

Zoetis • Chicago Heights, IL

488d

About The Position

This position supports quality operations, compliance systems, and objectives within the Chicago Heights, IL site. The candidate will maintain a quality mindset and implement continuous improvement efforts and quality system initiatives to meet industry requirements. This role will involve interaction with cross-functional groups such as Quality Control, Production, and Regulatory Affairs, ensuring that quality standards are upheld throughout the manufacturing process. The primary responsibilities include providing in-plant and on-floor support for cGMP product quality assurance and compliance for Manufacturing Operations and warehouse activities. The candidate will supply quality oversight for manufacturing and packaging operations, ensuring that the rationale behind quality applications is well understood. It is essential to establish and maintain approved quality systems, identify potential compliance gaps or risks, and communicate these to management effectively. The role requires the ability to provide quality oversight on the manufacturing floor, including assessing deviations and incidents, and supporting compliance efforts. The candidate will also be responsible for supporting and approving Manufacturing/Event Investigations, Corrective and Preventative Action (CAPA) records, and Laboratory Investigation records. Educating and mentoring site personnel on quality system requirements to achieve compliance goals is a critical aspect of this position. Additionally, the candidate will maintain compliance tracking systems, coordinate customer and supplier complaints, and support the release of finished goods documentation. This includes technical reviews of batch records, labeling, and lot deviations. The role also involves assisting in the development or revision of standard operating procedures and facilitating site FDA and regulatory compliance inspections. The candidate will uphold a state of constant inspection readiness and perform internal compliance audits, developing and maintaining an audit plan to prioritize focus points. The position requires proactive improvement of internal processes and products, providing regulatory compliance support for submissions and approvals, and ensuring the use of operational excellence tools in quality procedures. The candidate will monitor site quality systems performance through Key Quality Performance Indicator (KPI) Dashboards and support data integrity assessments and computer system validation plans. Other duties may include assisting in mock recall activities and maintaining the Food Safety Plan for the manufacturing site.