Senior Quality Assurance Scientist

Job Description

Job Summary:

• 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.

Duties and Responsibilities:

Primary:

• Ensuring the accuracy and compliance of data revisions to Instructions for Use (IFUs) and Change Orders related to label revisions.

Secondary:

• Providing comprehensive Quality Assurance support for Reagent manufacturing processes.
• 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.
• Collaborating with cross-functional teams to identify, contain, and disposition non-conforming product.
• Interacting effectively with development, technical operations, and manufacturing personnel to uphold quality standards, minimize rework and waste, and maximize product satisfaction.
• Establishing and driving daily management actions for quality processes that align with broader initiatives.
• 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.
• Master’s degree in a science or engineering discipline with 3+ years of relevant experience.
• 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.