Sonali Devi Yee Email & Phone Number

San Diego, Ca, Us

Plymouth Meeting, Pa, Us

• Write appropriate QC Inspection procedures such as SOPs, Work Instructions, validation protocols andreports with ability to focus on technical and detailed level of information.• Drive and/or support investigations of non-conformances.• Participate in Batch Record review (DHR), release of manufacturing product and components at variousstages.• Report discrepancies to management for process improvements.• Perform dimensional inspection using standard quality measuring equipment i.e. Keyence or applicableprogrammable automated inspection equipment.• Provide feedback for problems occurring in the processing, fabricating, assembling and testing of productsand develop changes and corrections to prevent reoccurrence.• Be able to if needed conduct inspections and testing methods and participate in the preparation of qualityassurance specifications and procedures to implement such methods.• Participate and or be the QE lead in the review of engineering specifications to assure that adequate qualityassurance requirements are met.• Review drawings for adherence to design inputs; material callouts and standards and procedures; andregulatory and QS requirements; verify that required reports are attached so that the project can proceed tothe next phase.• Perform other duties as required.

Abbott Park, Illinois, Us

CAPA Administration – Responsible for ensuring CAPA system is being managed effectively. · Provide site administration of the CAPA program and support process owners in completing CAPAs and related business items. · Support and guide the Corrective Action Review Board and Users regarding the CAPA process, CAPA record content, and CAPA software. · Support the development, implementation and continuous improvement of Quality System CAPA procedures, CAPA software, and CAPA training. · Ensure implementation, and effectiveness verification of CAPA and participate in remediation of legacy CAPA files. · Ensure that CAPA records are complete and they contain accurate links and references to other Quality processes such as Change Management, Non-Conformance, and Complaint Handling. · Manage the archival and handling of scanned CAPA records. · Critical Review of documents. Experience in assessing the weight of evidence associated with a claim/hypothesis/assertion is preferred. · Demonstrates commitment to the development, implementation and effectiveness of ARDx Quality Management System per ISO, FDA, and other regulatory agencies. · Provide ongoing support to Quality management during external audits. · has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities · Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships · Carries out duties in compliance with established business policies

Waltham, Ma, Us

Research and generate packaging ideas for innovative projects that deliver value to the business.- Identify and implement packaging productivity projects that can reduce material & freight cost.- Develop and execute on project plans that deliver continuous Improvement to cost, quality, and service.- Identify and implement packaging productivity projects that reduce Packaging material and Freight cost.- Perform financial validations and justifications for productivity projects.- Proficient in the use of ERP systems, MS Word, Excel, PowerPoint and Access

San Diego, California, Us

Supports quality activities and projects to successfully meet department and corporate goals. Key contributor in support and collaboration for the following: State, Federal, and international distribution and manufacturing licensing, FDA establishment licensing and device listings, Audits, Quality Management System Regulation and Standards, Additional quality responsibilities as assigned. Works closely with Quality, Commercial, Legal, Planning, and Operations to ensure compliance with numerous agencies and requirements. Assists and supports the organization in complying with, as well as the ongoing preparation, testing and monitoring of conformance to, the requirements of government regulations and/or regulatory agencies. Performs evaluation of internal operations, controls, communications, risk assessments and maintenance of documentation as related to regulatory compliance and recommends appropriate changes. Conducts and facilitates internal and external audits to identify, evaluate, disclose, and appropriately remedy risks and deficiencies. Coordinates the preparation of and may prepare document packages for regulatory submissions from all areas of company as well as for internal and external audits and inspections. May serve as point of contact for interactions with regulatory agencies for defined matters. Researching and completion of state, Federal and international manufacturing and distribution licensing laws, rules, and statutes for applicability Project management Support internal and external audit activities as assigned (fulfill audit requests, review records for accuracy, scribe, etc.)

Franklin Lakes, New Jersey, Us

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.OnsiteExperience working with Quality SystemsExperience working with Validation Plans (IOPQ)

Waltham, Ma, Us

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.

Franklin Lakes, New Jersey, Us

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. •. 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

• 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 Park, Illinois, Us

• 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

Los Angeles, Ca, Us