Quality Assurance Specialist

We are seeking a highly skilled Quality Assurance Senior Scientist to support Reagent Manufacturing Quality Assurance. This is an on-site contractor position focused on ensuring product quality and compliance within a manufacturing environment.In this role, your responsibilities will include:• PRIMARY:o Ensuring the accuracy and compliance of data revisions to Instructions for Use (IFUs) and Change Orders related to label revisions.• SECONDARY:o Providing comprehensive Quality Assurance support for Reagent manufacturing processes.o Ensuring strict adherence to design change procedures, relevant corporate policies, and global regulations (e.g., FDA QSR, ISO). You will provide guidance and make decisions to prevent deviations or non-conformances.o Collaborating with cross-functional teams to identify, contain, and disposition non-conforming product.o Interacting effectively with development, technical operations, and manufacturing personnel to uphold quality standards, minimize rework and waste, and maximize product satisfaction.o Establishing and driving daily management actions for quality processes that align with broader initiatives.o Evaluating quality system performance and leading continuous improvement events to enhance process efficiency.Essential Requirements:• Bachelor's degree in a science or engineering discipline with 5+ years of relevant experience, OR• Master's degree in a science or engineering discipline with 3+ years of relevant experience, OR• Doctoral degree in a relevant field with 0-2 years of relevant experience.• Familiarity with electronic document management systems, particularly those handling PDF files. -Preferred Experience:• Prior experience in Quality Assurance.• Experience working within a regulated industry.

Created: 2025-10-02