Ori Reches Email & Phone Number

Redwood City, California, United States

Oversee and participate in the execution of viral vector manufacturing according to defined SOPs and manufacturing batch records within a cleanroom environment.Operate and troubleshoot process equipment such as TFF skids, incubators, functionally closed system bioreactors, and controlled rate freezers.Buffer preparation.With Quality Assurance, supervisor, and Facilities, ensure preparedness for runs in terms of equipment readiness and operator training.Troubleshoot OOE and OOT issues during routine manufacturing.Manage, provide guidance, and support a team of manufacturing associates.Collaborate with MS&T to refine MBRs and with SCM to generate supply orders to support BOM.Must possess high degree of learning agility.Support Quality Management system including but not limited to deviation investigations and risk assessments.Understand and implement safety procedures.

Mountain View, California, United States

In addition to the responsibilities listed as Quality Control Associate I: Primary contact for QC related inquiries Participate in project-specific client meetings. Coordinate with external labs to execute 3rd party testing to ensure final reports are received prior to target deadlines. Review project-specific QC Data and ensure reports are reported to the QA Department in a timely manner for lots to be released in a timely manner. Schedule and provide in-process manufacturing support and schedule, manage, and execute Stability Studies for client projects. Participate in tech transfer processes by assisting in the development of tech transferred assays and reviewing new documents associated with the tech transfer process

Mountain View, California, United States

Perform the accurate execution of test methods and proceduresMaintain inventory of QC materials and lab supplies, including monitoring and orderingPerform maintenance, monitoring, and troubleshooting of pertinent equipmentPerform reagent and media preparationCompliant with all applicable SOPs and good documentation practices(GDP) as well as cGMP/GCTP requirementsConduct test, review and release test results for products or materialsPerform and assist in equipment qualification and method validations as neededPerform state proficiency testing and/or client proficiency testing under direct supervision as applicableInvestigate Out of Specification (OOS), Out of Trend (OOT) and/or non-conforming test resultsAssist in investigations, and preparation of deviation reports, with input from the manager or lead, in a timely manner and implements corrective actions and preventive actionsPackaging and shipping samples to contracted Laboratories for testing and/or to ClientsDetermine causes and develops preventative actions of Deviations, Non-Conformances, OOS, OOT, field complaints and environmental excursion investigations.Conduct investigations to true root cause using appropriate investigation tools.Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets.Implement effective preventive actions to prevent recurrence.Handle multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates.Track and create appropriate trending rules that trigger corrective actions.Provide communication plan for on-going deviations & CAPA’s.Effectively create and execute communication plan for CAPA’s and on-going deviations to responsible parties.Conducts timely completion of deviations, CAPAs, and Change Controls as necessary.Ability to comply with quality standards.

Mountain View, California, United States

Performs any and all required processing and manipulation required to produce and assess safe and efficacious products Proficiently functions within an ISO Class 7 and 6 cleanroom environment, ensuring personal and product safety Consistently produce documentation with accuracy and clarity in accordance to Good Documentation Practices and Good Manufacturing Practices Proficiently performs testing and assess product content and safety according to company’s established procedures Stem cell preparation, cell/tissue culture and manipulation using aseptic techniques Performs cryopreservation of products using DMSO based solutions and controlled-rate freezers Proficiently operate equipment according to designed procedures Manipulate products according to established standard operating procedures and batch records such as enrichments, depletions, cell expansions, or volume reductions to achieve predetermined endpoints Performs the monitoring and maintenance of critical equipment such as ultra-cold freezers, storage tanks, refrigerators, freezers, and incubators. Participating in clinical trial support and studies, may include but not limited to sample preparation, sample shipping, media and reagent preparation. Notifying management of any deviation that may occur during processing or during equipment maintenance. Performing investigations for deviations and completing deviations in a timely manner Participate in the on-call program

Alameda, Ca

Perform and document routine preventative maintenance, and non-standard equipment repairs. Support manufacturing by solving equipment-related manufacturing problems. Install new equipment and complete IQ/OQInterpret and communicate test results. Provide design enhancements to equipment and fixtures for improvement of throughput, yield, and/or ergonomics. Train production staff on proper use of equipment.

Alameda, Ca

Perform a wide variety of tasks and processes that are required to build, assemble, inspect, and package products in a controlled manufacturing environment using microscopes and small-handled tools. Maintain compliance with GMPs, Quality Manual, Standard Operating Procedures, Work Instructions, and company standards.

Uc Davis

Ran computer simulations to determine errors in a dependent variable called A-P tibiofermoral contact locations Analyzed collective data on Geomagic and Paraviews

Israel

Internship program through Career Israel on Track.Prepared and performed lab experiments using a pocketed sensor to record the nutrient value of alcohol, cheeses, and fruits.Recorded and collected data on Softwares, such as Hugos and MyWorks.Used and cleaned lab instruments, such as beakers, burners, test tubes, and thermometers

Davis, Ca

Planned Shabbat and Jewish Holidays by organizing the theme, booking service leaders and performing a day of coordination for the events. Planned and prepared meals including food preparation, cooking, and kitchen sanitization.

Davis, Ca

Assisted the kitchen manager in food preparation and kitchen sanitization.