ABBOTT LABORATORIES Specialist Document II Salary in the United States

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 103,000 colleagues serve people in more than 160 countries.

This position is responsible for implementing the document and change control process and providing support for document and parts change orders. Assist in developing and maintaining software database systems (e.g. PLM) supporting quality system data within the Document Control department. Changes may include product improvement, design corrections and new product development. The documentation specialist will be working in a fast-paced, interdisciplinary team that will demand exceptional support, thoroughness and attention to detail, excellent verbal and written communication and editing skills, strong execution and organizational skills, and the ability to work independently to support a team.

Requirements

Create, analyze and process Engineering Change Orders (ECs) in compliance with FDA, QSR, ISO9001, ISO13485 and Abbott    standards.

Additional Responsibilities:

Assist in maintaining a company wide Data Management System.

Create, analyze and process ECs for new product development and upgrades while coordinating EC activity for Document Control.

Coordinate ECs through the department in preparation for the Change Control Board (CCB) review and approval process.

Assist in resolving moderately complex issues, provide judgments and recommendations to manager.

Assist in defining and documenting EC procedures and standards.

Provide customers (internal and external) technical assistance in Change Control procedures.

Qualifications:
B.S. degree or equivalent.   Related experience with Document Control and Change Order systems is required, preference 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 independently 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. Demonstrate proficiency in Microsoft Office suite and Adobe Acrobat preferred. Highly organized and detail oriented with strong follow-up skills to manage large volumes of documentation a plus. Ability to understand priorities is highly desired.