Harold Sanchez
About Harold Sanchez
Harold Sanchez is a Senior Manufacturing Associate at Alkermes in Wilmington, OH, with extensive experience in cGMP operations and a background in Religious Education and Electrical and Electronics Engineering.
Title and Current Role
Harold Sanchez is a Senior Manufacturing Associate at Alkermes, located in Wilmington, OH. In his current role, he oversees day-to-day cGMP operations, which include safety, production, troubleshooting, and coordination with various departments such as QA, Training, Microbiology, and Maintenance. He also handles material handling of equipment and components used in GMP manufacturing, including their decontamination and preparation.
Past Roles at Alkermes
Before becoming a Senior Manufacturing Associate, Harold Sanchez served as a Training Associate at Alkermes from 2007 to 2010. Prior to that, he worked as a Bulk and Polymer Manufacturing Associate at the same company from 2005 to 2007. His career at Alkermes, all based in Wilmington, OH, has spanned different roles where he gained experience in various aspects of manufacturing and operations.
Educational Background
Harold Sanchez studied at the Heritage Baptist Institute, where he earned a Bachelor's degree in Theology, focusing on Religious Education, from 1999 to 2003. Prior to that, he attended ITT Technical Institute in Cleveland, Ohio, where he studied Electrical and Electronics Engineering from 1998 to 1999.
Responsibilities and Expertise
In his role as a Senior Manufacturing Associate, Harold Sanchez is responsible for managing shift responsibilities in the absence of a Supervisor. He operates critical equipment like steam sterilizers and dry heat ovens and performs employee gown sampling with rodac plates. Certified in Vial Inspection activities, he is also a qualified trainer of cGMP processes and documents in LMS. As one of six Core Captains and Subject Matter Experts (SMEs) for filling operations, he ensures operator safety and workflow during fill events. He reads biological sterilization indicator strips, trends, and approves sterilization loads in SCADA.
Operational Duties and Documentation
Harold Sanchez manages a variety of essential operational duties. He writes routine work orders for fill support and equipment repairs in Maximo, a comprehensive maintenance management software. He assists team leaders with SOP revisions, executes change controls, and writes deviation reports. His role demands hands-on involvement with both the operational and administrative aspects of GMP manufacturing processes.