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EXACT SCIENCES CORPORATION Core Associate Scientist II Technical in MADISON, Wisconsin

JOB REQUIREMENTS: Help us change lives At Exact Sciences, we\'re helpingchange how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you\'re working to help others. Position Overview The Core Associate Scientist II, Technical Transfer role will assist in a variety of technical transfer activities facilitating process and product transfer into Operations. This position will develop, document, and implement new processes and procedures as part of the design transfer process. Essential Duties Include, but are not limited to, the following: Support Operations in design and development of In Vitro Diagnostic (IVD) medical device manufacturing processes and procedures in accordance with cGMP, ISO13485, and FDA guidelines. Assists execution of development batches per a defined build plan, assists Production Operators in troubleshooting issues that arise during development manufacturing. Develops and characterizes formulation processes for simple buffers or mixtures. Executes process development and pilot scale manufacturing for simple processes/products such as buffers and reagent dilutions. Support Process and Test Method Validation readiness and execution. Provides support and review in generating Validation documentation. Supports identifying critical processing parameters and critical quality attributes. Assists troubleshooting and root cause investigation efforts with understanding of recognized tools. Write new and edit existing Quality System documents. Recognizes continuous improvement opportunities for the Quality System. Responsible for generating/driving corrective actions/action plans for more complex change requests/change orders, SOPs, work instruction, receiving inspection methods, and technical summary reports. Participates in identifying and developing manufacturing training strategy/techniques for new manufacturing processes. Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. Support and comply with the company\'s Quality Management System policies and procedures. Maintain regular and reliable attendance. Ability to act with an inclusion mindset and model these behaviors for the organization. Ability to work designated schedule. Ability to work... For full info follow application link. We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company\'s affirmative action program are available to any applicant or employee for inspection upon request. ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/20E9A9ACFCE343D4

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