Lora Irene Email & Phone Number

South Holland, Netherlands

Remote, Usa

Played key role in moving multiple clients from paper to electronic validation using ValGenesis validation life cycle management solution. - Analyzed clients’ processes and systems and configured settings and master data to customize software. - Conducted conference room pilot sessions to give clients hands-on experience with product.- Presented demonstrations and trained groups with as many as 40 users on ValGenesis functionality.- Refined product and assisted with upgrades by providing demos, training, and validation documentation of delta features.- Served as first point of escalation, performing troubleshooting, creating tickets, and working with technical teams to resolve bugs quickly.- Performed dry run testing of validation test scripts.

Novato, California, United States

Promoted to manage projects to improve production planning and materials tracking at manufacturing sites. Served as the technical interface representing business units for implementation of IFS software. Analyzed systems, identified gaps, and developed business process flows to adapt IFS tools to meet business requirements.- Represented GMP Oligo Planning and Manufacturing departments in the implementation of Material Requirements Planning (MRP) software for the first time.- Created standard operating procedures (SOPs), Visio flowcharts, and PowerPoint presentations and led end-user training.- Created the Production Planning Department for 4 oligonucleotide manufacturing labs. Analyzed end-to-end processes to improve functions and results. Partnered with scientists to understand equipment and equipment capacity.- Decreased manual data entry 90% by developing a GMP automated production schedule.- Increased tracking visibility 100% for all batches in production for the sites.- Cut oligonucleotide production turnaround time (TAT) by 30% - 50% by analyzing variables that affect manufacturing to determine times for discrete tasks and establishing reasonable durations for those times.- Improved client satisfaction by being able to provide reliable estimates of TAT and faster delivery for orders.- Enabled raw materials to be available on site when needed and increased communication among colleagues by restructuring and implementing daily use of a Raw Materials Calculator.- Ensured accurate and timely responses by implementing monthly reporting on first pass yield (FPY), TAT, and on-time delivery (OTD).

Novato, California, United States

Spearheaded multiple projects to increase the efficiency and effectiveness of production planning. Proactively worked to create, document, and train users on improved processes for tracking materials, gathering information, and creating production requests. - Led cross-departmental project to create a process flow for handling customer-supplied materials, -partnering with Customer Service, Purchasing, QA, Planning, and Synthesis departments to identify pain points, gather requirements, and determine project scope. - Established processes for controlling movement of customer-supplied materials.- Eliminated loss of materials provided by customers. - Decreased TAT by as much as 300% for obtaining materials from customers.- Trained end users in Production Planning, Customer Service, QA, and Purchasing departments.- Spearheaded effort to gather DMT and Synthesis Instrument data for approximately 3,000 manufactured oligo parts.- Eliminated ambiguity and DNRs (Deviation Investigation and Non-Conforming Product Control Reports) relating to incorrectly generated robot files.- Proactively originated projects to streamline process for initiating production requests. Collaborated with AppDev to spec and implement a feature to process multiple batches simultaneously.- Eliminated human error and prevented DNRs caused by incorrect documentation.- Reduced time for initiation of production requests by up to 30%.- Increased control and oversight of documentation for GMP Oligo Productions.

San Francisco Bay Area

Citrus Heights, Ca