Luis Sandoval Herrera Email & Phone Number

San Pablo, CA, US

Redwood City, California, United States

• Responsible for providing QA oversight and support for batch disposition, quality record ownership, and management of QA activities.
• Represent QA on cross-functional teams and serve as a resource for quality and compliance questions, issues, and planning across the development organization, including providing guidance based on current global.
• Collaborate with internal and external stakeholders on deviation investigations, CAPA plans, change controls, shelf-life extensions, and revisions to documentation.
• Lead efforts for QA oversight of the manufacture and disposition of pre-clinical, clinical, and commercial product materials, DS, DP, and FP at CMOs in partnership with CMC, Supply Chain, Analytical Development, and.
• Execution of Quality Systems as Quality SME for Deviations, CAPAs, Change Controls, and other Quality processes.
• Lead and actively participate in continuous improvement initiatives and projects, ensuring a focus on increasing both efficiency and quality output from all processes used by cross-functional partners.

San Carlos, California, United States

• The role is responsible for the primary, hands on, day-to-day, cGMP oversight role for all site related GMP ac-tivities. They interact directly with site staff, who are performing the daily operational functions in.
• Responsible for commercial product, raw materials and components release, disposition and material handling as part of the support supply chain planning (NOSSCE)
• Provides oversight to operations on the shop floor, supporting operators and support staff as needed to identify and address product quality and compliance issues as they arise.
• Responsible for driving product quality improvements by coordinating investigations and corrective actions with all operating units, QA, Site Services, and suppliers. Evaluation and decision of deviation reports in.
• Support Quality Assurance and Compliance with internal audit coordination, response, and follow-up activities.
• Participate in or lead internal/external audits, as needed.

San Carlos, California

 Hands-on day to day, GMP facilitator for all site-related GMP activities Release commercial product, raw materials and components, material handling and support of Supply Chain Planning Business Process Owner (BPO) of NOSSCE for Master Schedule Production Quality (MSPQ) and On-Time-Batch Approval (OTBA) Coordinate investigations and corrective actions.

San Carlos

Review batch documentation for accuracy and completeness according GMPs to ensure timely release and also help to final disposition.Support implementation of CAPAs, SOP revision, Approved Deviation using trackwise.