Compunnel
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
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 Qualifications
Prior experience in Quality Assurance. Experience working within a regulated industry.
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
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 Qualifications
Prior experience in Quality Assurance. Experience working within a regulated industry.