Job Description
Job Description
JOB TITLE: Quality Assurance Scientist
JOB LOCATION: Chaska, MN(Onsite Position)
Contract Duration: 06 months
JOB DESCRIPTION:
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.
Secondary:
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:
• Bachelor's degree in a science or engineering discipline with 5+ years of relevant experience, OR
• Master's degree in a science or engineering discipline with 3+ years of relevant experience, OR
• 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