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.• Support IOQ, OQ, and validations as needed.• Administer the equipment continuous monitoring system (CMS), Vaisala viewLinc.• Perform technical review of validation documentation for select laboratory equipment.• Report and coordinate non-conformities for failed and malfunctioning equipment.• Assist with the review and revision of facilities delegated procedures for compliance and workflow.

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 electronic document management system (EDMS), I collaborate with authors in the review of standard operating procedures and instructions on a regular review cycle through formatting documentation to Cerus style and standards.My duties include:• 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 using the EDMS, including revision processes and good documentation practices.• 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 proposed process updates, User Acceptance Testing (UAT) script building and execution, and updating/creating training procedures. • 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. • Communicating with document owners the requirements and progress of document submissions into the EDMS.• Conducting and monitoring the two-year review of procedural and quality documents.• Performing corrective/preventive action (CAPA) process investigation of delinquent two year old documents, using root cause analysis.

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 system EDMS.Duties include:• 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• Work closely with authors and document owners to ensure correct processing of documents including technical review and editing of documents as needed• Perform other related duties as required

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 is up to date and records are completed.My duties included:• 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 service records, and collaborating with engineering and manufacturing to develop service plans and records.• 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, Paraffin-Embedded KRAS products in a in a cGMP ISO 13485 environment; inventory management and laboratory upkeep; batch record quality review; and collaborated in site projects including:o Written software validation protocols for new commercial software in laboratory validation and the usage of qPCR instruments for feasibility studies in research and developmento Produced work instructions and a design plan in manufacturing to support custom manufacturing