HomeIllinoisDocumentation Specialist II

North Chicago, IL

Documentation Specialist II

LocationNorth Chicago, Illinois 60064
Employment TypeContractor
Date Posted2023-05-21
Direct Apply
Valid Through2024-04-01

Job Description:


This position provides assurance of adherence to AbbVie documentation standards and principles. The role is primarily responsible for managing the creation and revision of Quality System and processes documents including assessment of proposed changes taking all controlled documentation and processes into account. Furthermore, acts as Subject Matter Expert for Quality documentation administration (Change Control) and is the interface between RDQA QS Documentation Management group and supported R&D functions.


  • Ensures all administrative documentation requirements are met for supported Quality Documentation inclusive of document processing and records management.

  • Facilitates the creation/revision, administration, review, and approval (as applicable) of new and revised Quality Documentation within the Document Management System (DM)

  • Maintains notifications, relations, and other property information within the Document Management System (DMS).

  • Participates in supporting R&D project and initiatives and continuous improvement projects related to documentation management as applicable.

  • Supports and coordinates of document translation process (incl. Translation checking (LU only) as applicable.

  • Collects and reports documentation-related key performance indicator metrics.

  • Provide input into overall team strategy and framework development for new and emerging initiatives (incl. mid- and long-term team goals).


  • High School diploma or Associates degree with minimum of 3+ years’ experience in pharmaceutical industry (production and/or quality assurance) or related field required.

  • OR Bachelor's degree with 1-2 years of pharmaceutical experience in a GMP environment administering Document Control Systems and 1-2 years’ experience using and administering electronic document management tools.

  • Completed technical / commercial education (for Germany-based candidates)

  • Basic understanding and knowledge of GxP requirements and pharmaceutical regulations preferred.

  • Advanced knowledge and hand-on experience with Document Management Systems OR other database applications

  • Advanced organizational skill, attention to detail

  • Experience with Microsoft Office products, incl MS Word processing / formatting experience

  • Advanced spoken and written English skills (OUS only))

  • Excellent verbal and written communication and interpersonal skills

  • Strong independent contributor and team member in a fast-paced environment. Ability to work effectively in a team environment.

  • Builds strong relationships with peers and cross-functional partners to enable timeline completion of document lifecycle.

  • Detailed oriented with solid problem-solving acumen.

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.

Job ID: 5855154776411632574

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