Alfredo Roesadi
Quality Engineer at Thermo Fisher Scientific
Quality Engineer at Thermo Fisher Scientific
Motivated and quality driven professional with quality operation, control, validation and molecular biology background.

Specialties: Cleaning Validation, Equipment Validation, Cleaning System Validation, Controlled Environmental System Validation, Computerized System Validation Deviation Investigation, CAPA, LIMS, cGMP/cGLP, Document audits, Regulatory and Compliance, Quality, Research and Development, Inventory Management, Property Management Fluent in Indonesian
Thermo Fisher Scientific
https://www.linkedin.com/company/thermo-fisher-scientific
Quality Engineer
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Siegfried Holding AG
https://www.linkedin.com/company/siegfried-holding-ag
Project Manager
Irvine, California, United States
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B. Braun Medical
https://www.linkedin.com/company/b--braun-medical-inc.-us
Quality Engineer
Irvine, California
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Grifols
https://www.linkedin.com/company/grifols
Validation Engineer
•	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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Grifols
https://www.linkedin.com/company/grifols
Quality Control Microbiologist
•	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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Grifols
https://www.linkedin.com/company/grifols
Quality Operation Specialist (Environmental Monitoring)
•	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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The Master's College
https://www.linkedin.com/company/the-master%27s-college
Research Assistant
•	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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Molecular Biology
BS
The Master's University
https://www.linkedin.com/school/the-master's-college/
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Six Sigma Green Belt (SSGB)
Institute of Industrial and Systems Engineers
Certified Quality Auditor
ASQ - World Headquarters
https://www.linkedin.com/in/carolin-banoub-3b9197146
Carolin Banoub
Quality Associate II
Irvine, CA
https://www.linkedin.com/in/jedrimae
Jedri Emralino
QA Specialist at LGM Pharma
Orange County, CA
https://www.linkedin.com/in/colearoberts
Cole Roberts
Manager, Facilities & Metrology  at Thermo Fisher Scientific
Orange County, CA
https://www.linkedin.com/in/iamjoeyt
Joey Tang, PMP
Manager at CompassX
San Gabriel, CA
https://www.linkedin.com/in/caroline-yorke-9246892a
Caroline Yorke
Quality Specialist II - Quality Systems at Thermo Fisher Scientific
Valley Village, CA
https://www.linkedin.com/in/jasminxz
Jasmine Zhang
Engineer II, Process at Masimo
Irvine, CA
https://www.linkedin.com/in/salvador-jimenez-a3b35892
Salvador Jimenez
Quality Assurance Inspector at Gilead Sciences
Azusa, CA
https://www.linkedin.com/in/marcel-chavez
Marcel Chavez
Quality Assurance at Drinkpak
Los Angeles, CA
https://www.linkedin.com/in/leila-tehrani-793807b9
Leila Tehrani
Scientist III IVD at Thermo Fisher Scientific
San Diego County, CA
https://www.linkedin.com/in/mohsenkarbaschi
Mohsen Karbaschi, PhD
IVD Product Development Scientist
Mountain View, CA
https://www.linkedin.com/in/thao-nguyen-8ba542122
Thao Nguyen
Quality Assurance Specialist at Avid Bioservices
Garden Grove, CA
https://www.linkedin.com/in/ethan-peng-a49a5064
Ethan Peng
Manufacturing Specialist at Grifols
Covina, CA
https://www.linkedin.com/in/djmfranklin
David Franklin
Maintenance Supervisor at Baxter International
Anaheim, CA
https://www.linkedin.com/in/jacob-lu-scientist
Jacob Lu
QC Chemist
Diamond Bar, CA
https://www.linkedin.com/in/sara-cuviello-0bb70a85
Sara Cuviello
QA Associate II at Siegfried Holding AG
Orange County, CA
https://www.linkedin.com/in/tigran-galstian-29a32531
Tigran Galstian
Manufacturing Operations Leader
Los Angeles County, CA
https://www.linkedin.com/in/brody-mullen-50388385
Brody Mullen
Clinical Trials Project Manager at Eli Lilly and Company
Greater Indianapolis
https://www.linkedin.com/in/kradwan
Khalid Radwan
Project Manager at Zenith Technologies
San Diego, CA
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.
Many people have viewed my profile trying to figure out why I left 13-year worth of effort.  People are waiting for me to post my secret new job.  I…
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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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Shared by Alfredo Roesadi
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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Liked by Alfredo Roesadi
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The Master's University Alumni
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ASQ - Excellence Through Quality
https://www.linkedin.com/groups/3633
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IQ OQ PQ Validation
https://www.linkedin.com/groups/2343097