1+ months

Documentation Specialist

Princeton, NJ

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Abbott Point of Care is a global leader in providing with-patient diagnostic testing solutions that are fast, portable, accurate and affordable. We are a division of Abbott, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics.

Our i-STAT System is an advanced, handheld system that allows medical staff to perform diagnostic testing without having to leave the patient's side. The system provides real-time, lab-quality results using only a few drops of blood and delivers accurate results in minutes rather than hours. The i-STAT System family of products and services fosters a collaborative, patient-centered environment while driving improved operational performance. Our products can play a valuable role in accelerating the patient-care decision-making process throughout the continuum of care. More than 80,000 i-STAT handhelds are used worldwide by healthcare professionals in a variety of settings.

By choosing to transform the healthcare industry and how we do business, we will continue to provide healthcare professionals with the resources they need to deliver high-quality, efficient and affordable care to the patients they serve.

Position Summary

Assist Information Design team in developing, editing, proofreading and maintaining labeling artwork and associated documentation for the various i-STAT Analyzer and data management systems within the Abbott Point of Care quality system.  Responsible for routing, approval,  procurement and review of all English and translated labeling, as projects are assigned by team members. 

Additional Main Responsibilities

Essential functions:

Create, analyze, verify and process design change packages (DCPs)  in compliance with FDA, QSR, ISO9001, ISO13485 and Abbott

standards.  Multiple design changes to be coordinated and implemented simultaneously to meet divisional scheduling requirements.

Assist Information Design team in redlining (markups), editing, proofreading and formal routing and approval of artwork in English and other languages.

Appreciate deadlines for multiple projects and hold internal teams accountable to meet schedules.

Additional Responsibilities:

Facilitate product labeling artwork changes and approvals using both internal and external (vendor) resources.

Assist in resolving moderately complex labeling issues, providing judgments and recommendations to team.

Experience with MS Word, Adobe Acrobat Pro, Project Management, Good Documentation Practices, Proofreading, Excellent communication.

Preferred but not required: Adobe InDesign, Graphic Design skills.

Additional Qualifications

B.S. degree or equivalent. Related experience with Document Control and Change Order systems is required, preferrably in a

regulated environment such as medical devices industry. Working knowledge of QSR, ISO, standards relating Document and

Data Control. Prefer experience with Agile software. Strong interpersonal and communication skills. Works effectively with

others while providing high level customer service. Works moderately independantly requiring only moderate supervision.

Sustains moderate to high judgement on moderately complex non-routine tasks. Able to prioritize work. Exercises judgement

with defined procedures and practices to determine appropriate actions.. Makes task related decisions daily.
Job Family: Operations Quality
Division: APOC Point of Care
Travel: No
Medical Surveillance: No
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)


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Documentation Specialist

Princeton, NJ

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Princeton, NJ

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