Jonathan Silo Email & Phone Number

Concord, California

• Manage maintenance and calibration duties as it applies to laboratory equipment compliance.Laboratory equipment compliance management:
• Manage all quality aspects associated with Cerus laboratory equipment.
• Organize and update all Cerus HQ laboratory PMs and calibrations information in the asset management system.
• Coordinate and ensure all calibration and equipment preventative maintenance and repairs are scheduled, completed, and documented in a timely manner.
• Provide training to laboratory users on equipment compliance processes and equipment management related software.
• Maintain calibration and equipment files and ensure records are properly documented and filed.

Concord, California, United States

As the Equipment Compliance Specialist for Cerus, I manage the equipment program including maintenance scheduling, record keeping, and I work with laboratory personnel to determine equipment requirements needed for GLP laboratory operations. I also work in the shipping and receiving department to maintain warehouse operations.

Concord California USA

• As the Technical Editor for Cerus, I review and format study protocols and reports for development and chemistry, manufacturing and controls departments. In addition to my role of coordinating document revisions in the.
• System administration of the Electronic Document Management System (EDMS); manage and monitor the change request process in a Good Manufacturing Practice (GMP), ISO 13485-regulated environment; training new users in.
• Conducting validation activities related to EDMS software upgrade including: gathering user feedback on current and proposed changes to the system, troubleshooting software functionality, reviewing user requirements to.
• Reviewing and formatting study protocols and reports to comply with standard templates and styles.
• Reviewing stability reports and data for completeness prior to entry into the EDMS.
• Coordinating with Project Managers to ensure that Regulatory submission documents are completed and approved, according to company timelines.

Concord California USA

• As a document coordinator for Cerus, my primary function focuses on coordinating the control of documents (initiation, approval, issue, archival, retrieval, and deactivation) through an electronic document management.
• Serve as a system administrator for the EDMS; manage and monitor the change request process in a Good Manufacturing Practice (GMP), ISO 13485-regulated environment
• Conduct and monitor mandatory (periodic) review of standard operating procedure documents
• Update and edit standard operating procedure documents as required
• Ensure that documents conform to company templates, internal formats, and styles
• Maintain document logs, spreadsheets, and databases

Pleasanton California USA

• As a senior quality assurance technician for the Thermo Fisher Scientific oligo manufacturing operations, my role primarily focused as the calibration administrator to ensure that equipment maintenance and calibration.
• Managed the calibration administration program, such as organizing equipment service deadlines, coordinating with laboratories in completing and investigating instrument specification issues, storing and organizing of.
• Change control analyst; worked with document/product owners to revise documents/parts and coordinate with the necessary approvers.
• Supporting the audit program through preparation of documents for external auditors and audit internally for compliance to ISO 13485.
• Trained in Practical Process Improvement 8-Step Process Improvement. This program improves processes through analysis of the relationship between process and people, while using data to generate solutions.

Benicia California USA

As the manufacturing technician in AcroMetrix, my function primarily served to build both catalog products and custom products in a cGMP manufacturing environment. My duties included formulation of bloodborne standards and controls (such as HIV, HBV, and HCV) for commercial research use or in-vitro diagnostics and formulation of Formalin-Fixed.