Senior Software Quality Assurance Engineer (Wheaton,IL) - (Wheaton, 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