Senior Quality Assurance Scientist

JOB SUMMARY

We are seeking a highly skilled Quality Assurance Senior Scientist to support Reagent Manufacturing Quality Assurance in an on-site contractor role. This position is responsible for ensuring product quality, compliance with regulatory standards, and the integrity of manufacturing processes. The Senior Scientist will play a critical role in reviewing and managing data revisions, supporting reagent manufacturing operations, and driving continuous improvement initiatives to uphold the highest quality standards.

Key Responsibilities

• Ensure accuracy and compliance of data revisions to Instructions for Use (IFUs) and Change Orders related to label revisions.
• Provide comprehensive Quality Assurance support for reagent manufacturing processes.
• Ensure strict adherence to design change procedures, corporate policies, and global regulations (e.g., FDA QSR, ISO).
• Provide guidance and make informed decisions to prevent deviations or non-conformances.
• Collaborate with cross-functional teams to identify, contain, and disposition non-conforming product.
• Partner with development, technical operations, and manufacturing personnel to uphold quality standards, minimize rework and waste, and maximize product satisfaction.
• Establish and drive daily management actions for quality processes that align with broader initiatives.
• Evaluate quality system performance and lead continuous improvement events to enhance process efficiency.

Required Qualifications

Preferred Qualifications