Ops Label & Kit Design Associate IV

Abbott Laboratories; Madison (WI); On-site; USD 61,000 - 123,000; Full time

Job summary

Abbott Laboratories is seeking a Label & Kit Design Associate IV to support design transfer and continuous improvement for labeling and kitting in manufacturing. The role involves developing, validating, and implementing new labeling processes, documents, parts/BOMs, and SOPs, with on-site work in Madison, WI up to four days per week.

Responsibilities include preparing production label templates, updating BOMs, and coordinating with multiple functions to meet regulatory and quality standards.

Qualifications

• Bachelor’s degree in Biology, Chemistry, or a related life science field is required or equivalent experience.
• 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 RUO.
• Proficient in Microsoft Office Suite.

Responsibilities

• Assist in design and development of labeling and kitting processes for IVD or RUO manufacturing per cGMP/ISO13485/FDA guidelines.
• Support creation and maintenance of SOPs, Work Instructions, BOMs, and change control documentation.
• Coordinate with cross-functional teams across sites to implement label and kit design changes.

Education

Bachelor’s degree in Biology, Chemistry, or related life science field

Tools

Microsoft Office Suite

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION

Position Overview

TheOps Label & Kit Design Associate IV role will assist in a variety of design transfer and continuous improvement activities facilitating new labeling and kitting implementation into production. This position will support development, documentation, validation, and implementation of new labeling and kitting processes, documents, parts/BOMs, and procedures into production as part of the design transfer process. 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

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.

Minimum Qualifications

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.

Preferred Qualifications

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.

Job Details

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. JOB FAMILY: Manufacturing DIVISION: ONCO Cancer Diagnostics LOCATION: United States > Madison : 650 Forward Dr ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Equal Opportunity

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO Laws

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Company Overview

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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