Ops Label & Kit Design Associate IV

Position Overview

This role may also train to and participate in Production functions supporting labeling and kitting of development materials or finished goods using manual or automated processes.

This role requires consistent onsite presence in Madison, WI up to four days a week.

Essential Duties

Include, but are not limited to, the following:

• Assist in 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.
• 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, 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, and process validation batch production.
• Ability to follow written procedures with minimal direction.
• Ability to prioritize tasks and adhere to project schedules while effectively working on several varied projects at one time, with frequently changing priorities in an evolving environment.
• Ability to complete assignments in expected time frames and independently seek out additional work when tasks are completed ahead of time.
• 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 use a telephone or computer through a headset.
• 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 utilize lab 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.

• Bachelor’s degree in Biology, Chemistry, or a related life science field. Equivalent experience may be considered in lieu of education.
• 1+ years of experience with daily operations, SOP documentation, and instrument use in a heavily regulated environment such as biotech manufacturing in a FDA GMP or ISO 13485 environment for IVD or Research Use Only.
• 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.

• Experience writing SOPs in a heavily regulated environment such as biotech manufacturing in a FDA GMP or ISO 13485 environment for IVD or Research Use Only.

The base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted.