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.
• 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.

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