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, Facebook, Instagram, YouTube and LinkedIn.
Principal Quality Engineer
Lake County, IllinoisReq ID 2202162Category Information TechnologyDivision 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 Software Quality Assurance Manager – Software Life Cycle Management.
Lead a team of 5-6 contractors/employees as a team lead, handle invoicing, reviews
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 Information Research are compliant to the internal and external policies, processes and procedures
Establish quality system requirements for the Information Research.
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 Information Research and compliance issues
Generate or review and provide feedback on various documents related to qualification/validation eg calibration, SOPs, VMPs etc
Participate and take lead on process improvement projects
Provide guidance and supervision to contracting staff
. Minimum of 4 years of experience in Quality Assurance or related field such as regulated GxP environment in qualification/validation, documentation or compliance.
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.
Experience with GxP regulations, internal policy/ procedures as well as FDA (GCP/GLP/GMP/21CFR Part 11), SOX, HIPPA, and International (ICH, Annex 11).
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)