Label Editor - Abbott Nutrition - Columbus, OH or Abbott Park, IL

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

JOB DESCRIPTION:

This position is responsible for overseeing and managing the change control packages for product labeling and for ensuring that documentation is appropriate, justified, and approved by responsible functional areas according to established procedures. Also responsible for proofreading resulting labeling copy at various stages and for the development and maintenance of labeling related specifications and documentation associated with these specifications. Additional responsibilities will include participation with new product teams plus successful completion of assigned projects.

Responsible for implementing and maintaining the effectiveness of the quality system.

Edits, reviews, proofreads and approves labeling change control documentation and associated specifications such as OP, MS, PBOM, PMS, etc. Reviews labeling for consistency with similar or related products specifications. Communicates and coordinates labeling and documentation approvals with other sites. Must be able to rearrange priorities on short notice to react to customer needs. This individual may be expected to supervise others within the department as necessary. This includes, but is not limited to, project management.

Accountability /Scope

Labeling and documentation for new products or revisions must be completed accurately and on time. Quality of the product is directly linked to the accuracy of the associated documentation. Not meeting the scheduling requirements will result in a delay in new product introduction, which can have a far-reaching effect on product sales and can further result in a delay in implementing design improvement which in turn can affect labor cost and product marketability. Failure to produce accurate copy can result in loss of printed supplies and potential product recall or field action. Documentation associated with the labeling change control process must meet Quality, Regulatory and GMP requirements, as they are official records for audits and legal actions.

Education

BA/BS degree or equivalent experience in Science, English, Business or related field to ensure accuracy of highly technical information used by manufacturing operations and regulated by the FDA. Alternately, the direct relevant technical experience sufficient to demonstrate the knowledge typically associated with degree and experience required.

Experience

Requires a minimum of two to four years' experience in a technical/quality or operational area and knowledge of the labeling change control process. This position is expected to be a resource or mentor for less experienced, lower level editors within the dept. Must have the ability to problem solve, manage projects, influence internal and external groups and provide leadership. The incumbent should have a proven record of leadership with strong organizational and human relations skills to deal with various levels of individuals and functional areas within the division. Previous experience working within a change control system is helpful. Knowledge of DMS/AMM and word processing is desirable.

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