Jose Negron

Quality Control professional with extensive experience in regulated pharmaceutical manufacturing, specializing in semi-solids and biologics. Strong background in laboratory support projects, including analytical equipment qualification,decommissioning, and waste characterization, with full adherence to global and internal procedures. Experienced in biochemistry and Raw Materials testing, as well as documentation generation and review.

Proven success ensuring compliance with GMP, ISO 14001, EPA, RCRA, and DOT requirements. Skilled in conducting gap assessments, implementing risk-mitigation actions, and supporting regulatory readiness. Recognized for excellent communication, teamwork, and leadership in laboratory compliance and safety programs.

Leader for the quality control laboratories (biochemistry & microbiology), overseeing performance, compliance, monitoring, preventive and corrective actions, issues resolution, and best practice sharing providing technical knowledge of EHS compliance standards. Responsible laboratory EHS and regulatory audits (EPA, RCRA, iso 14001). Accountable for laboratory area and site inspection, preparing the team to manage EHS inspections and following up corrective actions, and collaborating with recommendation and process improvements.

In charge of all related EHS&S programs such as code of conduct, good savings, waste management, recycling and others. Conducted monthly inventory of reagents and provided support focused on the identification and implementation of areas improvements in the laboratory area. Responsible for all laboratory explosive reagents inventory accountable for the certificate of compliance for the storage, management and use of explosives material in the site facilities and addressing the regulatory authorities visits to our facilities.

Bachillerato en Ciencias Generales con concentracion en Biologia