Clara Ca Operations Technician
Resume:
Ankit Patel
*******************@*****.***
EDUCATION:
Bachelor of Science in Biology May 2012
San Jose State University, San Jose, CA
●Major: Molecular Biology
●Minor: Chemistry
Summary: Have multiple years of experience with product development process and leading project areas. Lead and Manage quality programs under ISO13485 and 21 CFR Part 820 guidelines and documentation. Collaborate and coordinate across functional areas such as R&D, Marketing, Product Management, QA/QC, Regulatory, Operations and Manufacturing. I also have experience with documenting process change & validation/verification, process implementation, improvement and root cause analysis, V&V, PPQ, IQOQ, CAPA, FMEA, PFMEA, SPC, GMP and FDA regulation for 510K, EUA submission for IVD products. Knowledge of FDA's GMP regulations (QSR 820 and 210/211), IEC 62304, ISO 13485 and risk management (ISO 14971).
EXPERIENCE:
Manager, Clinical Services Quality
Vitalant, San Francisco CA Feb 2021 to Present
Host external inspections. Assist in facilitating responses to observations. Ensure corrective actions were implemented and effective. Perform review of documents to ensure processes are within control. Participate on review team to evaluate nonconforming products, materials, or test results and assesses the impact on external customers. Ensures required actions are implemented. Assist in the oversight of Clinical Trial Studies. Conduct data and process analysis activities including in-depth analysis of deviation and operational performance data. Evaluate data for trend and opportunities for improvement. Lead and participate in process design activities for new and changed processes in identified operational subject matter areas. Participate in the development, evaluation, and launch of workflow standards documents. Participate in change implementation and evaluates process changes to include where applicable, planning, pre-implementation, and post-implementation audits.
Support the internal audit program. Assist operations in evaluating observations, performing investigations, and root cause analysis. Aid in the development of corrective action. Perform follow-up on audit observations. Track responses, monitor implementation, and ensure effectiveness of corrective action. Perform failure mode analysis, risk analysis, risk assessments, and flow analysis of process changes. Conduct analysis on pilot and validation study data. Analyze process changes. Track and trend deviations. Identifies areas for improvement and communicates these issues to operations. Ensure all required deviation management reports are accurate and timely. Ensures data entry is performed and events are accurately coded in data management system. Reviews and approves corrective action. Performs effectiveness checks for corrective actions.
Sr R&D Engineer (Contractor)
Lucira Health, Emeryville CA May 2020 to September 2020
Used Solidworks to design parts and fixtures.
Plan and perform experiments to optimize device performance, including developing experimental protocols, executing tests, and analyzing data.
Compile test data statistically analyze results and develop test reports, and presentations to summarize findings.
Develop fixtures and experimental tools to aid in testing and product development.
Assist with the procurement of supplies and general laboratory maintenance.
Maintain clear and concise documentation of developed processes in a lab notebook.
Collaborate cross-functionally with other team members and external development partners.
Train and operate within established quality system.
Validation Engineer
Fluidigm Corporation, South San Francisco CA July 2018 to May 2020
Performing facility verification and validation such as cold storage room and dry room.
Manage PM/Calibration program for manufacturing equipment.
Lead equipment acceptance and validation programs related to ISO13485 and 21 CFR Part 820 guidelines and documentation.
Point person for equipment management and validation program during audits.
Ensure all reagent manufacturing equipment and processes are properly validated and conform to regulatory requirements.
Be responsible for preparing IQ/OQ/PQ/PPQ validation protocols and reports.
Develop and execute FAT, SAT, IQ, OQ and PQ protocols for manufacturing processes, systems, and equipment.
Used Solidworks to design parts and fixtures.
Knowledge of FDA's GMP regulations (QSR 820 and 210/211), ISO 13485 and risk management (ISO 14971).
Work with external vendors to schedule and document PM/calibration visits per the equipment master plan.
Interface with a variety of cross functional work teams to ensure new products and processes are efficiently transferred into manufacturing
Evaluate new equipment requirements and prepare RFQ documentation
System Test Engineer II (Contractor)
Beckman Coulter, West Sacramento CA September 2017 to February 2018
Preparation of appropriate documentation as required by internal quality system and regulatory agencies (e.g. FDA, ISO, IEC).
Development of software tools to enhance and automate software verification.
Design and development of test plans and test cases.
Application of concepts/ principles in software and medical instrument verification & validation.
Investigation of software, hardware, and system problems using a variety of testing techniques.
Participation in technical decisions affecting product modules and subsystems, including functional specifications, technical reviews, and source code inspections.
Support and troubleshooting of test framework and environments.
Support of project activities such as planning, scheduling, and risk management.
Recommendation of process improvements.
Execution of test plans and test cases.
Research Associate II, R&D (Contractor)
Bio-Rad laboratories, Pleasanton CA March 2017 to July 2017
Validating Gene Expression assays (GEX), Copy Number Variation assays (CNV) and Rare Mutation Detection assays (RMD).
Working with Digital Droplet PCR (ddPCR) technology to study cancer markers.
Contributing to research and design of content for ddPCR instruments for RUO
Participating in instrument validation and verification activities limited to content and reagent testing.
Participating in assay and reagent design testing.
Executing Research & Design studies, generating data and drawing conclusions.
Creating presentation to document and update project teams on content research findings.
Scientist II, R&D (Contractor)
Siemens, Berkeley CA October 2015 to September 2016
Work with stakeholders from cross-functional teams to complete projects.
Participate in instrument & software testing and development activities.
Create experiment reports with research data points.
Writing Feasibility, Validation and Verification planning documents.
Writing SOPs for design transfer to manufacturing.
Work with Biostatical group to analyze complex data for large projects.
Work with Clinical Affairs group to generate line data and tabulate data for regulatory submission.
Train Clinical Affairs group to analyze data and on SOP’s for new assays testing
Working under FDA 21 Clinical Federal Regulation (CFR) part 50, 54, 56 and 11
Performing clinical studies data analysis and collection.
Analyze of clinical test data for development and research studies
Create and follow data collection format based on regulatory and quality assurance guidelines for project studies.
Use statistical software such as JMP or Excel to analyze data generated from clinical studies.
Apply scientific and statistical principles to design and conduct semi-complex multivariable experiments.
Analyze data to accomplish a variety of technical tasks for PCR-based molecular diagnostics assay development.
Operate liquid-handling robots and thermocyclers.
Write Protocol for studies for new product development
Design and conduct experiments, summarize data, interpret results and draw conclusions.
Troubleshoot and resolve project issues.
Research Associate (Contractor) July 2015 to October 2015
Abbott, Santa Clara CA.
Writing protocols for studies for new product development.
Instrument development studies.
Working with Blood Cell counters.
Use MS Excel to analyze data generated from studies.
Working with cross-functional team to complete project.
Designs and conducts experiments, summarize data, interpret results and draw conclusions.
Preparing summary reports based on test results and conclusions.
Presenting scientific observations to others.
Supporting all on-going patient sample (normal and abnormal whole blood) and fixed control material testing in laboratory, investigational research and/or process improvement projects.
Maintaining and troubleshooting testing instruments and documenting all maintenance/testing records.
Maintain laboratory by following GMP/GLP guidance.
Scientist, Assay Development (Contractor) April 2015 to June 2015
Roche, Pleasanton CA.
Helping in Feasibility studies for HPV
Helping in Development of HPV Assay for FDA approval
Working with HPV samples clinical and contrived
Performing Assay reagent stability studies
Performing plasmid level of detection studies for different genotype
Performing experiment to test clinical samples for HPV
Analyzing data using JMP and other PCR analyzing software
Scientist I, Production June 2013 to April 2015
Life Technologies/Thermo-Fisher Scientific, Pleasanton CA.
Leading the SPC data collection team.
Designing SOP's and creating SOP's from R&D research.
Working with PCR based platform.
Implementing new process changes in manufacturing.
Writing Validation Plans and Validation reports.
Approving Validation Plans and Validation reports.
Validating new equipment in manufacturing as per GMP.
Perform Corrective and Preventive Actions (CAPA).
Collecting and presenting SPC data, for multiple processes.
Preform process improvement projects.
Designing process improvement projects.
Root cause analysis for manufacturing process.
Resolving root cause issues for manufacturing process.
Creating new SOP’s for new equipment that are going to be implemented in manufacturing.
Helping in design of Experiment that best produce product yield from instruments.
Preforming surface chemistry experiment for R&D research.
Following GMP and FDA regulations for research purposes.
Implementing new equipment in manufacturing process.
Process optimization audits and experiments.
Ordering supplies and equipment for the R&D Lab, as well as manufacturing Lab.
Operations Technician (Contractor) January 2013 to June 2013
Life Technologies, Pleasanton CA.
Performing various chemical procedures and using various equipment to create final product.
Following SOP for coating metal steels for micro array production.
Troubleshooting and resolving production issues.
Aiding in Validation process for equipment and materials.
Aiding in the setup and organization of raw materials in the area
Preparation of solutions required during processing
Hands-on processing of material required to support customer orders
Handling material transfers from building to building
Prepping material prior to use in Manufacturing
Cleaning lab-ware
Documentation
Use of MS Office tools and other computer software
Archiving documentation
Final packaging work
Inventorying materials currently in stock
Performing 6-S activities
Updating paperwork/SOPs.
Reporting out metrics
Contributing to the overall productivity and efficiency of Manufacturing
Operator II (Contractor) May 2011 to Jan 2012
Seagate (Research and Development Facility), Fremont CA.
Running experiment parts on the Wash machine assigned by the development Group.
Running experiments with different recipes and wash machines.
Qualifying the machine before running the experiment parts.
Always work in a Clean room with Class #1000 (only 1000 particles/cubic meter) and followed ISO: 1000 protocols.
Making sure the equipment is setup to the recipe indicated for the experiment.
Do equipment checking inside and outside the machines.
Verify the correct experiment parts are selected and washed correctly.
Perform any Experiment deviation specified by the development team.
Keep complete record of the experiment and related information.
References: available on request
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