ABBOTT LABORATORIES Document Editor II - Nutrition - Abbott Park, IL 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.

Primary Function/ Primary Goals/ Objectives:

The primary function is to review, and process change request packages to maintain necessary division level documentation consisting of policies, procedures, and/or product specifications.  Function in an advisory role regarding document management and change control practices. 

Major Responsibilities:

• Review division level change request packages and documentation for assigned document types.  This may include but is not limited to: product manufacturing, packaging and testing documents, and Quality System Documents.  The incumbent ensures that any changes made are documented, justified, and approved by the required functional areas according to established procedures.
• Interact with change request initiators and approvers to resolve discrepancies.  Utilize various software programs for document review, cross-referencing and distribution.  Support of change control systems, resolving questions and proposing changes/improvements. 
• Provide assistance on projects according to areas of expertise.  Complete special projects and routine work on schedule.
• Maintain documents and data according to standard operating procedures.
• Provide guidance to stakeholders in the understanding of the QSD structure/process.  Providing technical writing support to subject matter experts, and specifically, change request initiators.
• Convey technical expertise via solid written and oral communication
• Must be able to rearrange priorities on short notice to react to (internal) customer needs and / or provide audit support.

Education:

• Bachelor’s degree is required.  A major or minor in a scientific discipline is highly desirable.

Background:

• Minimum of 2 years of Nutrition, Device, Pharmaceutical or other health care/industry experience in related operations areas such as manufacturing, materials management, quality control, quality engineering, document control, compliance, auditing, engineering and/or regulatory.
• Knowledge of policies and procedures impacting documentation and documentation practices.  Strong oral and written communication skills.
• Must know correct English grammar and syntax.
• Good people relations, able to work independently with good administrative and time management skills.  PC and Microsoft Office experience.
• Must be able to perform detailed, careful work, including proofreading of numerical values, equations, etc.

Accountability:

• Accountable to Abbott Nutrition Global Documentation management to assure the appropriate control and maintenance of AN division level specifications.
• Without division level documentation the plants could not manufacture product or implement and maintain the necessary Quality System elements.
• Accountable for review and approval of division product documentation to meet product launch dates.
• It is the responsibility of this position to resolve documentation issues preventing the issuance of product documentation in a timely manner so as not to halt or delay production.
• Failure to produce accurate documents in a timely manner can result in manufacture of adulterated products and/or unfavorable regulatory action.
• Leadership to proactively elevate issues and propose effective solutions.

Scope:

• This position is responsible for the final release of AN technical and quality documents and is the individual who assures the information is correct to the best of their ability, the proper approvals have been attained, all other document references are correct.
• Undetected errors at this level have the potential to cause significant negative impact in the areas of compliance, regulatory and manufacturing.
• This may require challenging individuals higher in the reporting structure as necessary.

MISC:

• MS Office Knowledge (specifically MS Word)
• No Relocation is offered for this role