Senior Software Quality Assurance Engineer (Lake In The Hills,IL) - (Lake in the Hills, IL)

Software Quality Assurance ensures computer system software meets qualifications 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 assignments include: Author, review/audit, and approve project documentation associated with the SLC to support applicable federal and regulatory qualifications 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