Sonali Yee

**** ** ****** **, *** Diego, CA *****, 760-***-****, aduarj@r.postjobfree.com

Education

California State University Los Angeles May 2015

Bachelor of Science in Biomedical sciences and Biotechnology

Palomar College Sep 2013

Associate of Science in Biological Sciences, Minor Biochemistry

Experience

Becton Dickinson

February 2022-

Quality Engineer

developing manufacturing processes, production floor layouts and associated tools. Reviews new designs for manufacturability. Designs process improvements to reduce product cost, process cycle time and improved product quality. Demonstrates working knowledge of Manufacturing Engineering principles and technologies.On-site

Experience working with Quality Systems

Experience working with Validation Plans (IOPQ)

Thermofisher Oct 2021-February 2022

Quality Engineer

Develop/ Write/Oversee IQ/OQ/PQ and PVs for Manufacturing Equipment and Processes

• Perform investigations and complete action items for open CAPAs

• Complete accurate and timely manufacturing documentation including manufacturing procedures, inspection procedures, materials records, etc.

• Develop new test methods and perform test method validation in compliance with FDA and ISO requirements.

•Other duties as assigned; as emerging growth company, it may be required from time to time to assist in other areas other than the area of specialty

•Support internal and external audits for compliance to ISO 13485 and FDA standards

• Good working knowledge of manufacturing equipment

• Good written and verbal communication skills

• Ability to resolve issues quickly and recommend preventive solutions

• Strong knowledge of statistical analysis

• Strong GMP and GDP knowledge

• Knowledge of MS office suite

• Working knowledge of 13485:2016

5 years’ experience working in FDA and ISO 13485 regulated company

5 years’ experience in biotech / IVD / Medical Device

• Experience with medical device manufacturing processes qualification (IQ/OQ/PQ).

• Product manufacturing, inspection, and testing experience

• Ability to work long hours and execute under pressure with short turnaround times

• Ability to speak, write, and use all office equipment including scanner and printer, phone, computer, etc.

Becton Dickinson Oct 2019-Oct2021

Biochemist/Operations specialist

The Operations Specialist I is a multi-functional role, responsible for inventory control of materials and finished goods, formulation, packaging, and order fulfillment. The Operation Specialist I also supports Quality Control of finished goods by performing dye labeling reactions and sample preparation. In addition, this position supports laboratory supply receiving and restocking.

• Support security and accuracy of inventory of materials and finished goods through transaction documentation and by conducting physical cycle counts and reconciliation of any discrepancies.

• Assist in the management of physical inventory within a Glovebox for raw materials, intermediate products, finished goods, analytical samples, and QA Retains.

• Perform small scale chemical reactions (dye labeling) for Quality Control testing.

• Fulfill internal requests for samples from inventory and perform sample preparation for quality testing.

• Perform Aliquoting/Vialing of air and water sensitive finished goods using manual and automated processes and equipment.

• Perform lyophilization of finished good products.

• Perform Weight Checks and Packaging of air and water sensitive finished goods within a glovebox.

• Prepare packaged products for QA inspection and shipments, including all required documentation.

• Accurately complete required documentation (batch records, data entry, etc.) on time.

• Receives deliveries of chemicals, materials, and lab supplies. Verifies accuracy of shipment and specifications. Checks materials into inventory management system and restock in proper storage areas.

• Support document control and data archiving activities as assigned.

• Promotes a safe work environment. Provide recommendations on maintaining the safety of the work environment. Participates in Environmental Health and Safety programs. Addresses corrective actions whenever a hazard is identified. Notifies supervisor of all observed hazardous conditions or unsafe work practices. Participates in safety audits of safety equipment and laboratory processes.

• Other responsibilities or projects as assigned by Supervisor

Risk management, Corrective actions, and CAPAs

Ajinimoto Biopharma Services

Jun 2018- Oct2019

QC Microbiology Analyst I

Environmental Monitoring (EM) of the utilities, controlled classified areas, and personnel. Performed EM according to standard operating procedures (SOPs). Performs routine cGMP and GDP and process specific EM within the Microbiology laboratory, manufacturing suites, and clean rooms.

Regulatory standard including ISO 13485 FDA CFR 21, part 11.

Sampling utilities including water, steam, and compressed gasses.

Process qualification of water, HVAC, and other systems.

Sterile Gown/cleanroom qualified.

Maintains lab area including routine cleaning of benches and incubators.

Performed: incubation, inoculation, and enumeration of gram stains and bacterial colonies.

Generating trend reports, incubator contents reports, and chemistry log book review.

Initiates environmental monitoring action level reports, deviation/non-conformance reports, and/or corrective action/preventative action (CAPAs).

Skills/techniques performed include Analytical High Performance Liquid Chromatography (HPLC), Mass Spectrometry, Capillary electrophoresis PCR, pipetting, experience with handling DNA, mRNA, and in vitro transcription, Experience with genome editing (CRISPR), strong cloning experience (standard cloning, PCR, mutagenesis, sequencing), cell culture experience. Streaking and sequencing of microbial recovery.

Collaborated with EHS and gave input in creating a safer work environment.

Lean Manufacturing: Implementing 6S schematics, and conducting 6S audits and reviews.

Perform analysis on complex, diverse data sets using statistical software.

Experience in Flow Cytometry:

Abbott Laboratories Jan 2018 - Jun 2018

QC Technician I

Testing in-process, stability/calibration, final release, reagent release and experimental devices

Operate laboratory equipment safely, as trained and directed, in accordance with established practices

Knowledge of federal and other regulations, eg. QSR’s, ISO 13485, CMDR, HIPPA

Responsible for inventory accuracy of all testing related materials

Demonstrates commitment to the development, implementation and effectiveness of Alere quality management system per ISO, FDA, and other regulatory agencies

Sprouts Farmers Market. Aug 2008 – Dec 2018

Grocery Manager

Responsible for addressing customer questions, concerns, and returns

Scheduling shifts, managing breaks, employee coaching, development, and performance review

Cash-handling and Safe management, loss prevention, and inventory management

Managed and advertised hiring fairs

Responsible for grand opening training of all new employees in the Southern California region.

Mission Animal & Bird Hospital Dec 2015 – Feb 2016

Analytical Chemist and Animal Science Technician

Prepared and analyzed water and soil samples according to SOPs within holding times

Reported results notified supervisors of any abnormalities and results above reporting limits in a timely manner, while ensuring the accuracy of tests and results with the use of quality controls.

Medical billing, filling out new and existing patient records, schedule writing, answering phone calls, cleaning exam rooms, pharmaceutical technician experience, filling and labeling prescriptions, cleaning kennels, animal husbandry.

CSU Los Angeles Jun 2013 – May 2016

Lab Assistant

Researched the binding of anionic molecules between triserine lactone derivatives

Performed experiments. Documented, organized, and summarized data as well as any irregularities to report to supervisor and team. Ensured integrity and preservation of samples with the use of proper storage and application techniques. Cleaned lab equipment and work area to ensure accurate results as well as a safe and efficiently functioning lab.

Palomar College Aug 2009 – Dec 2013

Lab Assistant

Documented, organized, and summarized data as well as any irregularities to supervisor

Filling out unit level record forms and site record forms. Archaeological survey and excavation.

Cataloging and dating artifacts (C14, Potassium/argon, and Thermo-luminescence dating).

Technical Skills

LIMS

SOPs

Pipetting

Microsoft Office (Word, Excel, PowerPoint, Outlook, Microsoft teams)

NVIVO WordCloud

Archaeological field technician

Master control

BMRAM

Experienced in C14 dating

Reagent/Buffer prep

Thermo-luminescence dating

Agar and broth inoculation

Column Chromatography

TLC (Thin Layer Chromatography)

•six sigma green belt

•Quality management systems

•Process FMEA

•writing and implementation of SOPs

•experience in investigations and CAPAs

•GDP and cGMP

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