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Specialist, QA Documentation
Specialist, QA Documentation-May 2024
Worcester
May 3, 2025
ABOUT ABBVIE
AbbVie is a pharmaceutical company that discovers, develops, and markets both biopharmaceuticals and small molecule drugs.
10,000+ employees
Biotechnology, Healthcare
VIEW COMPANY PROFILE >>
About Specialist, QA Documentation

  Evaluation that the contents of the Change Request (CR) package required by policy are present and filled out as received from the Change Champion.

  Route change request packages for review and approval, monitor responsiveness of approvers and assure appropriate approvals obtained. Communicate with initiator and customer for status updates and if implementation period needs to be negotiated.

  Type the revised documents after all approvals are obtained. Sole responsibility for ensuring that changes are incorporated accurately and are in compliance with established document formats and templates.

  Add / revise document properties. Establish document effective dates. Approve documents and properties in the document management system and release for distribution.

  Establish goals to maintain and improve performance, methods or efficiency and develop action plans to achieve personal and departmental objectives.

  Determine and implement problem solving and corrective action related to department and documentation processing activities.

  Complete work according to established priorities, policies, practices and procedures to assure product documentation is delivered on schedule.

  Maintain change request database for tracking of all documentation changes to ensure accuracy of status reports.

  Maintain a working knowledge of the capability and use of the department computer systems specific to document repository and change control business.

  Update and maintain relevant databases (for applicable changes to divisional documents).Manage the CR process for Division Departmental SOPs (e.g. Finance, Sales, Promo).Provide on the job training of new hires in the Doc Specialist role.

  Bachelor's Degree - Science or related field or equivalent experience

  1 - 3 years minimum experience in pharma or health care related industry.

  Knowledge of GMP.

  Strong interpersonal skills and strong oral and written communication skills.

  Must be able to work independently, set priorities, and establish action plans on a daily basis.

  Good problem solving skills

  AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. 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 protected veteran, or any other legally protected group status.

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