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 Lead Ops Specialist, Label & Kit Design role will support or lead a variety of design transfer and continuous improvement activities facilitating new labeling and kitting implementation into production. This position will develop, document, validate, and implement new labeling and kitting processes, documents, parts/BOMs, and procedures into production as part of the design transfer process. This role may also lead training and participation of Production functions supporting labeling and kitting of development materials or finished goods using manual or automated processes. Essential Duties Include but are not limited to the following: Support design and development of labeling and kitting for reagents to be used in In Vitro Diagnostic (IVD) or Research Use Only (RUO) medical device manufacturing processes and procedures in accordance with cGMP, ISO13485, and FDA guidelines. Establish Production Label Templates and Kitting Work Instructions, Receiving Inspection Methods, Technical Summary Reports, Standard Operating Procedures (SOPs), and other technical and GMP labeling and kitting documents, as required. Support implementation of new part numbers and Bills of Material (BOMs) via the Change Request / Change Order process, or via other means. Identify and support sourcing of raw materials or equipment necessary for labeling and kitting. Lead or support training and transfer of new processes and procedures to production operators. Mentor and develop junior level associates via training programs. Work externally to understand raw material sourcing, specifications, and risks in collaboration with Manufacturing Sciences, Quality Engineering, and Supply Chain teams. Act as project team member and Enterprise Labeling team representative for key business initiatives and continuous improvement projects. Participate in investigations and risk assessment activities, including Process Failure Mode Effects Analysis (pFMEA). Ability to design basic experimental plans and document results in technical reports. Strong problem-solving... 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/04100F4822C342C7