In this role, you will provide expertise to the QA department in one or more specialized areas such as computer system audits, lab investigations, root cause analysis, Total Quality Management ( TQM ) or other specialized areas.
The Quality Improvement Specialist will work directly with a regional team to support the regional goals in providing quality services. This person will be responsible for quality operational reviews, conducting internal investigations of critical incidents, coordinating implementation of training programs including conducting incident reporting training, monitoring compliance with regulations, licensing requirements and internal operating practices.
The Quality Specialist audits critical path processes and inspects results against specified requirements. Additionally, the Specialist understands Statistical Process Control and the application in an Engineer-To-Order manufacturing environment.
In this role, the selected candidate will provide technical/project management direction and assistance to internal/external customers, subcontractors, suppliers and licensees relative to quality related products and services and convince customer that quality problems have been resolved satisfactorily.
In this role, you will perform general quality systems support for SRA reagent production. This includes coordinating site product release, customer complaint investigations, and other quality system support functions as needed.
In this position, you will support the development and maintenance of key aspects in SAI Quality Systems, designed to meet the minimum regulatory and Quality requirements to assure compliance with FDA Quality Systems Regulations and ISO requirements.