Senior Quality Assurance Specialist

About the Company : We are seeking a highly skilled and experienced Quality Assurance Senior Scientist to join our team as an on-site contractor. This critical role is dedicated to upholding product quality and ensuring regulatory compliance within our Reagent Manufacturing operations.

About the Role : This position involves providing comprehensive Quality Assurance oversight and support for Reagent manufacturing processes.

Responsibilities :

• Provide comprehensive Quality Assurance oversight and support for Reagent manufacturing processes.
• Ensure rigorous adherence to design change procedures, corporate policies, and global regulations (e.g., FDA QSR, ISO). Proactively offer guidance and make informed decisions to prevent deviations and non-conformances.
• Collaborate effectively with cross-functional teams to swiftly identify, contain, and disposition non-conforming product.
• Interact proficiently with development, technical operations, and manufacturing personnel to sustain high quality standards, minimize rework and waste, and optimize product satisfaction.
• Establish and drive daily management actions for quality processes, ensuring alignment with broader departmental and organizational initiatives.
• Evaluate quality system performance metrics and lead continuous improvement events to enhance process efficiency and overall effectiveness.

Qualifications :

• Bachelor's degree in a science or engineering discipline with a minimum of 5 years of relevant experience, OR
• Master's degree in a science or engineering discipline with a minimum of 3 years of relevant experience, OR
• Doctoral degree in a relevant field.

Required Skills :

• Proven experience performing Quality Assurance functions within a regulated industry.

Preferred Skills :

• Experience with regulatory compliance and quality systems.