AbbVie Sr. Software Quality Engineer in North Chicago, Illinois
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter at https://twitter.com/abbvie , Facebook at https://www.facebook.com/AbbVieGlobal , Instagram , YouTube at https://www.youtube.com/user/AbbVie and LinkedIn at https://www.linkedin.com/company/abbvie .
Software Quality Assurance ensures computer system software meets requirements and is validated throughout the system's and the drug development's life cycles. The functional group will ensure high quality products and data compliant with GxP regulations, internal policy/procedures as well as FDA (GCP/GLP/GMP/21CFR Part 11), SOX, HIPPA, and International (ICH, Annex 11). We have a challenging opportunity for a Software Quality Engineer based in North Chicago, IL., reporting to the Senior Software Quality Assurance Manager.
Key responsibilities include :
Author, review/audit, and approve project documentation associated with the SLC to support applicable federal and regulatory requirements
Review/approve various qualification/validation plan documents, test strategies, test documents, summaries, and certification packages and associated deliverables as appropriate
Ensure recommended changes/improvements to support the Enterprise Systems are compliant to the internal and external policies, processes and procedures
Establish quality system requirements for the Enterprise Systems
Provides project quality leadership for validation or SLC activities
Create and apply risk-based approach strategies effectively and efficiently without compromising compliance
Approve key project deliverables
Serves as expert resource with regards to the Enterprise Systems and compliance issue
Generate or review and provide feedback on various documents related to qualification/validation eg calibration, SOPs, VMPs etc
Participate on process improvement projects
Bachelors with 5 years of experience in Quality Assurance or related field such as regulated GxP environment in qualification/validation, documentation or compliance.
Key AbbVie Competencies
Builds strong relationships with peers and cross functionally and with partners outside of the team.
Learns fast, grasps the “essence” and can change course quickly where indicated. Raises the bar and is never satisfied with the status quo.
Creates a learning environment, open to suggestions and experimentation for improvement.
Embraces the ideas of others, nurtures innovation and manages innovation to reality.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.
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