Rosemary Soto Email & Phone Number

United States

Responsible for reviewing Change Controls, overseeing Quality Agreements, and conducting Internal Audits. Present Investigations & CAPA, Escalations, and External and Internal audits system performance in monthly Quality Council meetings. Manage KPI metrics and contribute to the Site Inspection Readiness Program. Serve as the EtQ Local system administrator and have performed EtQ UAT testing.

External Manufacturing, Fort Washington Pa

Responsible for reviewing Change Controls and conducting Internal Audits. Present Investigations & CAPA, Escalations, and External and Internal audits system performance in monthly Quality Council meetings. Manage KPI metrics and contribute to the Site Inspection Readiness Program. Serve as the EtQ Local system administrator and have performed EtQ UAT testing.

Fort Washington, Pennsylvania, Estados Unidos

Led Site Quality Metrics program, ensuring standardized practices across sites. Supported Internal Audit and Inspection Readiness Program. Supported back room during third-party inspections and participated in internal audits. Conducted product complaint investigations and managed the Retain Samples program.

Fort Washington, Pennsylvania

Oversaw APR program, ensuring on-time completion. Core member & SME for External Manufacturing APRs. Reviewed batch records, represented in FDA Quality Metrics & E2E APR project. Reviewed/approved SAP Master Data.

Las Piedras

Led APR compilation, issuance, and completion. Conducted Batch Record Review, product disposition, and managed product holds and recalls. Oversaw Batch Record Review Team, ensuring compliance with GMPs, Corporate Policies, and Internal Procedures. Coordinated personnel tasks and training.

Guayama

-Contributed as a Team Member to the Annual Product Review (APR) team, playing a key role in designing and implementing a Global Product APR.-Investigated product complaints, evaluated field samples, and coordinated testing as necessary.-Served as Subject Matter Expert (SME) in the front room for corporate audits and BOH audits, including Cofepris, FDA, and ANVISA.-Conducted chemical and physical testing of raw materials, finished products, cleaning samples, and stability samples using advanced analytical methods.

Jayuya

Operated packaging machinery and equipment to ensure efficient and accurate packaging of products. Followed standard operating procedures (SOPs) and current Good Manufacturing Practices (cGMPs) to set up production lines, perform line cleaning, and execute clearance procedures. Maintained strict adherence to quality and safety standards throughout the packaging process. Additionally, collaborated with team members to troubleshoot any equipment issues and optimize production efficiency.

Bachelor, Chemistry

Master Of Business Administration - Mba

Certification, Biotechnology