Brandy Williams Email & Phone Number

Oak Brook, Illinois, United States

Maintain the Quality Management System/Change Control System (MasterControl) for quality and compliance. SME for cosmetic and OTC drug lip care, personal care, and healthcare products; manage the elements of the Product Master Files’ documentation lifecycle. Review and interpret product regulatory requirements from FDA OTC monographs and USP. Qualify raw materials and manage Raw Material Master File documentation lifecycle

Northfield, Illinois

Managed a high priority, high visibility project; involved drafting comprehensive product specifications/technical data sheets, for 800+ medical devices, to comply with regulatory registration requirements in various global markets. Managed the annual registration process for all medical device establishments/facilities. Co-lead a process improvement project achieving substantial, continuous cost savings. Managed a cross-functional team project; entailed product artwork/label updates, for 600+ medical devices and cosmetics, to comply with regulatory marketing requirements in Canada. Prepared and processed eCopy (electronic copy) for 510(k) (FDA medical device premarket approval applications). Reviewed product labeling and marketing for US and global compliance. Revised/updated existing regulatory documents by converting to fillable pdfs, using good documentation management practices

Arlington Heights, Illinois

Assisted customers with obtaining and maintaining supplemental registrations. Executed required legal and confidential documents for sub-registrations. Designed, reviewed and approved end-use pesticide labels to comply with Federal and State EPA and FIFRA regulations. Evaluated customer marketing and claims in order to prevent misbranding and violations per EPA. Notified EPA of new sub-registrations and cancellations. Managed documentation in SharePoint. Participated in a team process improvement project that resulted in an 80% reduction in liability exposure in one year. Researched and maintained knowledge of federal and state EPA regulations (EPA Label Review Manual, 40 CFR 150-189, and FIFRA PR Notices). Excelled in team collaboration and interpersonal communication skills by participating in monthly coaching/mentoring sessions (provided by Pearce Communications Group, LLC)

Des Plaines, Illinois

Interacted with internal/external sales, product management, customer service, and QA. Managed customer demands for quality and compliance. Prepared documentation packets for customer’s GFSI 3rd party audits. Organized food safety and quality related documents within ImageNow. Created customer reports in Great Plains and Microsoft Excel. Uploaded Certificate of Analysis and QA documentation to the TraceGains customer portal. Managed delivery orders for high priority customers.

Chicago, Illinois

Conducted full Measurement System Analysis (pH, salt, color fat, moisture, etc.) testing of each production line for quality product and equipment testing to achieve Three Sigma requirements for line certification, using Good Laboratory Practices and Good Manufacturing Practices. Trained production operators on testing procedures and devices (i.e. pH analyzer). Assisted Continuous Improvement and R&D with new methods and procedures. Daily calibration of testing equipment. Collected data to present in special projects and weekly assignments. Organized, planned, and executed projects. Entered and analyzed gage studies using Minitab Statistical Software 16 and Excel