Associate Scientist, Quality

Job description

POSITION SUMMARY: An Associate Quality Scientist is responsible for independently managing the testing, technical transfer, and troubleshooting of protein-based immunoassays. An Associate Quality Scientist will play a critical role in addressing failing product, documenting failures appropriately and determining an appropriate path forward. This position may supervise the work of others directly and/or across interdisciplinary teams. DUTIES AND RESPONSIBILITIES: - Review testing data and perform analyses including investigations of failures, as well as process and product performance trending and monitoring. - Provide descriptive statistical analysis using clear and concise methodologies and ensure accuracy and validity of data. - Conduct experiments, summarize results, and present recommendations to cross-functional teams including senior management. - Lead Material Review Board (MRB) meetings and facilitate discussions. - Initiate, coordinate, and/or be the Technical Lead of CAPA documents (Deviations, Non-Conforming Material Report (NCMR), etc.). - Establishes and monitors direct report performance and development goals, assigns accountabilities, sets objectives, establishes pri...