Specialist, QA Documentation

Specialist QA Documentation

North Chicago IL

Full-time

Company Description

AbbVies 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 peoples 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 . 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

Qualifications :

• Bachelors 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

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time