alfredo roesadi
Quality Engineer at Thermo Fisher Scientific
quality engineer thermo fisher scientific
motivated quality driven professional quality operation , control , validation molecular biology background . specialty : cleaning validation , equipment validation , cleaning system validation , controlled environmental system validation , computerized system validation deviation investigation , capa , lims , cgmp/cglp , document audit , regulatory compliance , quality , research development , inventory management , property management fluent indonesian
Thermo Fisher Scientific
https://www.linkedin.com/company/thermo-fisher-scientific
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Quality Engineer
Siegfried Holding AG
https://www.linkedin.com/company/siegfried-holding-ag
Irvine, California, United States
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Project Manager
B. Braun Medical
https://www.linkedin.com/company/b--braun-medical-inc.-us
Irvine, California
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Quality Engineer
Grifols
https://www.linkedin.com/company/grifols
•	Design, generate and execute approved validation protocol (IOPQ) by following established Validation Master Plan, cGMP and other regulatory requirements (USP and EP).
•	Compile, analyze validation data using statistical analysis and generate report as well as recommend changes for improvements or efficiency.
•	Investigate and resolve validation deviations and troubleshoot problems that occur during commissioning.
•	Perform scheduled requalification and/or qualification on controlled environmental systems (warehouse, walk-in freezer, walk-in cold box, walk-in incubator, laboratory freezer, laboratory refrigerator, laboratory incubator, transportation/shipping container), utilities (HWFI, CWFI, AWFI, PW, C/CA), Cleaning/Sterilization Equipment (CIP, COP, Manual Cleaning, SIP), Lyophilizer, Autoclave, Pasteurizer, Computerized System (Datatron Alarm System, TempTale, Ellab), steam quality test, vial washer
•	Proficient in thermal mapping equipment such as Kaye Validator, Ellab and TempTale.
•	Work cross functionally with various departments to complete the validation effort.
•	Participated in the validation effort for the approval process of two new major plant production operation facilities which doubles manufacturing output.
Los Angeles
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Validation Engineer
Grifols
https://www.linkedin.com/company/grifols
•	Performs Microbiological testing on Water, Raw Material, In Process Products, Finished Products and Stability samples - such as Bacterial Endotoxin testing, Particulate Matter testing, Bioburden test, Microbial Limits test.
•	Participate in validation and compatibility study of a change in method in LAL lab.
•	Produce media used for testing.
•	Tracking and trending of personnel and environmental monitoring results.
•	Supports the microbiology department by identifying or troubleshooting issues that may affect laboratory or facility monitoring systems or processes and other support to daily QC operations.
•	Participate in 3 CAPA investigations.
•	Support validation functions. Performs enumeration of Biological Indicators. Maintains user logs and BI history data.
•	Help create and revise standard procedures.
•	Maintain laboratory notebook in relation to validation studies.
•	Certified trainer for QC Microbiology
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Quality Control Microbiologist
Grifols
https://www.linkedin.com/company/grifols
•	Provide technical and administrative support for all activities to environmental monitoring, documentation, and quality auditing.
•	Collect and process environmental monitoring samples such as viable, non-viable, surface, personnel, water and gases as scheduled
•	Issue and/or investigate observation reports, environmental observation reports, corrective actions, and facilities work requests.
•	Proficiency and expertise with various QSP, LSP, MSP, FSP and CSOP relating to EM department.
•	Participate in various change control procedures.
•	Participate in CAPA investigations.
•	Perform daily audit of documents used in the department.
•	Participate in various internal or FDA audit of the department.
•	Perform equipment maintenance and calibrations (Climet CI 500, PMS, RCS+, SMA, MAS-100).
•	Manage inventory and supplies needed for the department
•	Train new hire with day to day operations and keep the department up to date on trainings and revisions.
•	Participated in validation of two new clean rooms in Los Angeles Grifols manufacturing plant.
•	Improved EM quality by implementing the MAS-100 and PMS viable and non-viable monitoring system.
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Quality Operation Specialist (Environmental Monitoring)
The Master's College
https://www.linkedin.com/company/the-master%27s-college
•	Participated in a research project locating TLR receptors on earthworms presented at the 32nd West Coast Biological Sciences Undergraduate Research Conference at Loyola Marymount University; maintained a notebook recording research experiments.
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Research Assistant
BS
Molecular Biology
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The Master's University
https://www.linkedin.com/school/the-master's-college/
Institute of Industrial and Systems Engineers
Six Sigma Green Belt (SSGB)
ASQ - World Headquarters
Certified Quality Auditor
https://www.linkedin.com/in/carolin-banoub-3b9197146
Irvine, CA
Carolin Banoub
Quality Associate II
https://www.linkedin.com/in/jedrimae
Orange County, CA
Jedri Emralino
QA Specialist at LGM Pharma
https://www.linkedin.com/in/colearoberts
Orange County, CA
Cole Roberts
Manager, Facilities & Metrology  at Thermo Fisher Scientific
https://www.linkedin.com/in/iamjoeyt
San Gabriel, CA
Joey Tang, PMP
Manager at CompassX
https://www.linkedin.com/in/caroline-yorke-9246892a
Valley Village, CA
Caroline Yorke
Quality Specialist II - Quality Systems at Thermo Fisher Scientific
https://www.linkedin.com/in/jasminxz
Irvine, CA
Jasmine Zhang
Engineer II, Process at Masimo
https://www.linkedin.com/in/salvador-jimenez-a3b35892
Azusa, CA
Salvador Jimenez
Quality Assurance Inspector at Gilead Sciences
https://www.linkedin.com/in/marcel-chavez
Los Angeles, CA
Marcel Chavez
Quality Assurance at Drinkpak
https://www.linkedin.com/in/leila-tehrani-793807b9
San Diego County, CA
Leila Tehrani
Scientist III IVD at Thermo Fisher Scientific
https://www.linkedin.com/in/mohsenkarbaschi
Mountain View, CA
Mohsen Karbaschi, PhD
IVD Product Development Scientist
https://www.linkedin.com/in/thao-nguyen-8ba542122
Garden Grove, CA
Thao Nguyen
Quality Assurance Specialist at Avid Bioservices
https://www.linkedin.com/in/ethan-peng-a49a5064
Covina, CA
Ethan Peng
Manufacturing Specialist at Grifols
https://www.linkedin.com/in/djmfranklin
Anaheim, CA
David Franklin
Maintenance Supervisor at Baxter International
https://www.linkedin.com/in/jacob-lu-scientist
Diamond Bar, CA
Jacob Lu
QC Chemist
https://www.linkedin.com/in/sara-cuviello-0bb70a85
Orange County, CA
Sara Cuviello
QA Associate II at Siegfried Holding AG
https://www.linkedin.com/in/tigran-galstian-29a32531
Los Angeles County, CA
Tigran Galstian
Manufacturing Operations Leader
https://www.linkedin.com/in/brody-mullen-50388385
Greater Indianapolis
Brody Mullen
Clinical Trials Project Manager at Eli Lilly and Company
https://www.linkedin.com/in/kradwan
San Diego, CA
Khalid Radwan
Project Manager at Zenith Technologies
Richard Kalman
      
          



            
              
        
              
  

    
        Alfredo was a great member of our project management team. He reported directly to me as a project manager. During that time, he did an exceptional job managing his projects. He is able to juggle multiple projects within and across multiple customers. Alfredo has good technical abilities and is able to understand all aspects of his projects. Alfredo has shown this with his management of projects across varying platforms and degrees of complexity. During the time I worked with Alfredo I always appreciated his support and collaboration. His technical abilities and good organization skills made him a successful project manager. He was always willing to take on new and challenging tasks. I could always count on him. His desire to continue to learn and grow as well as an eye on continuous improvement is something I admired.  In addition to being one of those individuals I wanted on my team, due to his technical expertise, he was always someone I looked forward to working with.
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Have you ever seen a root cause reported to be HUMAN ERROR?  Have you ever listed HUMAN ERROR as a root cause?When you have human error as a cause…
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Have you ever seen a root cause reported to be HUMAN ERROR?  Have you ever listed HUMAN ERROR as a root cause?When you have human error as a cause…
The Master's University Alumni
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ASQ - Excellence Through Quality
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IQ OQ PQ Validation
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