Specialist, QA Documentation

North Chicago, IL

Full-time

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Manage the change process of bulk and finished goods manufacturing and testing documentation consisting of specifications, SOPs, policies, manufacturing documentation, sampling and test methods for product and raw materials manufactured or purchased by the plant requiring service. Implement, control and coordinate changes in documentation. With minimal supervision, complete special projects and routine work on schedule.

Responsibilities:

• Collaborate with cross functional teams, as necessary, to ensure coordination of document change request activities with corresponding CAPA tasks, Change Plans, site priorities, production schedules, etc.
• 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.
• Serve as backup for other team members, as necessary