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.

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 :

Preferred Experience :