Annie Howe Email & Phone Number

Novato, California, United States

• Maintained MFG executed batch records and relevant documents to comply with FDA cGMPs guidance and regulations. Managed batch disposition activities to ensure lots were dispositioned in accordance with cGMPs, Regulatory, and Policies and Procedures to 100% adherence to the production schedule.• Supported management with Batch Records related correspondences from QC, QA CMO and regulatory agencies related requests; acted as SME for company Partners and FDA audits.• Assisted with Quality production campaigns planning within Binocs ERP system, ensuring 85% adherence to production schedules and contributing to a 10% reduction in production delays.• Assisted with Materials Batch Recipe building for Manufacturing by supported the development of over 300+ of batch recipes per year, ensuring accurate formulation and compliance with manufacturing standards.• Complied and analyzed key performance metrics (Batch Records Closure time, Batch Release time) on a monthly basis, delivering detailed reports to stakeholders. Highlighted operations and release timelines, contributed to an 80% improvement in meeting production deadlines and a 30% reduction in overall lead times.

Novato, California, United States

• Identified and revised company SOPs (QA) discrepancies to streamline QA process.• Acted as a QA Knowledge Manager; maintained Livelink, SharePoint and Department internal website.• Participated in Oracle EBS Expiration Date Function Meetings to ensure all MFG internal intermediate expiration dates were being captured in Oracle correctly.• Initiated Deviations and Change Requests and drafted investigational documentation.• Partnered with others to ensure batch disposition items were complete sent status updates to management.

Novato, California, United States