Reagent Scientist

Sunrise Systems, Inc.; Chaska (MN); On-site; USD 70,000 - 90,000; Full time

Job summary

A technology manufacturing company in Chaska is seeking a Quality Assurance professional to oversee manufacturing process compliance and improvements. The ideal candidate will hold a Bachelor's degree in a science or engineering field and have substantial experience in QA within regulated industries. Responsibilities include providing comprehensive QA oversight, ensuring adherence to regulations, and collaborating with cross-functional teams to promote product quality and satisfaction. This role offers an opportunity to drive continuous improvement in quality processes.

Qualifications

• Bachelor's degree in a relevant field plus 5 years of QA experience.
• Master's degree plus 3 years of relevant experience.
• Proven QA experience in regulated environments.

Responsibilities

• Provide QA oversight for Reagent manufacturing processes.
• Ensure adherence to design change procedures and corporate policies.
• Collaborate with teams to identify and resolve non-conformities.
• Interact with technical and manufacturing teams to maintain quality.
• Drive daily management actions for quality processes.
• Lead continuous improvement events to enhance process efficiency.

Skills

Quality Assurance oversight

Regulatory compliance

Cross-functional collaboration

Process improvement

Education

Bachelor’s degree in a science or engineering discipline

Master’s degree in a science or engineering discipline

Doctoral degree in a relevant field

Job description

Key Responsibilities:

• Provide comprehensive Quality Assurance oversight and support for Reagent manufacturing processes – e.g., SOP approvals, equipment record approvals, non conformances, out of specification events, etc.
• 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.
• Proven experience performing Quality Assurance functions within a regulated industry.