Lead Ops Specialist, Label & Kit Design

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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 skills.
• Strong oral and written communication and interpersonal skills and ability to coordinate work with other sites, enterprise wide.
• Ability to work collaboratively with Production, Manufacturing Sciences, Quality Control, R&D, Quality Engineering, Regulatory Affairs, Supply Chain, and other functions, to meet business objectives.
• Work collaboratively with external vendors to meet labeling requirements and collection kit packaging requirements defined by internal standards.
• Support processes and exhibits capability through execution of development, pilot scale, and process validation batch production.
• Ability to prioritize tasks and adhere to project schedules and timelines while effectively working on several varied projects at one time, with frequently changing priorities in an evolving environment.
• Ability to work designated schedule with regular and reliable attendance.
• Ability to complete tasks onsite.
• Ability to work effectively in team situations, as well as independently.
• Strong attention-to-detail.
• 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.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to lift up to 50 pounds for approximately 5% of a typical working day.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability to use laboratory equipment and moving machinery.
• May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.
• Ability and means to travel between Madison locations.
• Ability to travel 5% of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications

• Bachelor's degree in Biology, Chemistry, or a related life science field. Equivalent experience may be considered in lieu of education.
• 3+ years of experience with daily operations, SOP documentation, instrument use in a heavily regulated environment such as biotech manufacturing in an FDA GMP or ISO 13485 environment for IVD or Research Use Only.
• 2+ years of experience with Agile or other electronic Quality Management Systems (eQMS) for creating documentation or reports, or process implementation through the change control process.
• Proficient in Microsoft Office Suite.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• Professional working knowledge or coursework with IVD product labeling, kitting processes, and/or medical device products in a cGMP manufacturing and/or technical role.
• Experience with NiceLabel, BarTender, Adobe Illustrator, or other labeling software for label generation and creation.
• Knowledge in continuous improvement methodologies/principles, such as LEAN Six Sigma.
• Experience with project management principles and practice.

Salary Range:

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.

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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. Any applicant or employee may request to view applicable portions of the company's affirmative action program.

To view the Right to Work, E-Verify Employer, and Pay Transparency notices and Federal, Federal Contractor, and State employment law posters, visit our compliance hub. The documents summarize important details of the law and provide key points that you have a right to know.