QAO Specialist I

CSL • Bradley, IL

504d

About The Position

This entry-level position in Quality Assurance Operations at CSL Behring is designed for individuals looking to start their careers in the healthcare industry, specifically within a cGMP (current Good Manufacturing Practice) regulated environment. The role involves assisting with the investigation of deviations relevant to the area of responsibility, which is crucial for maintaining compliance and ensuring the quality of products. The successful candidate will be responsible for driving continuous improvement on the production floor, ensuring that all operations adhere to cGMP standards. This includes real-time review of batch records and critical processing steps, necessitating a presence on the production floor to effectively monitor and assess compliance. In this role, the specialist will participate in investigation meetings with relevant departments and support groups, contributing to the research necessary to determine root causes of deviations. The position requires collaboration with manufacturing personnel to perform root cause analysis at the time deviations occur, assisting in the development of robust corrective and preventive actions. The specialist will also be on-call for immediate inspections and investigations, providing quality assessments of potential GMP-related issues as they arise. Additionally, the role includes executing training and awareness programs related to investigations and GMP changes for production personnel. The specialist will ensure that the sample retain area is maintained in compliance and that all annual inspections are completed timely. Performing Acceptable Quality Level (AQL) assessments may also be part of the responsibilities, depending on the area of responsibility. This position is integral to maintaining the high standards of quality that CSL Behring is known for, and it offers a solid foundation for a career in quality assurance within the healthcare sector.