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Click here or scroll down to respond to this candidateCandidate's Name
Chemical Scientist/R&D Engineer
Auburn Hills, Michigan, United States
PHONE NUMBER AVAILABLE
EMAIL AVAILABLE
WORK EXPERIENCE
October 2021-January 2024
Chemical Scientist/R&D Engineer
Biological
Newark, Delaware, United States
*Created, prioritized, managed, and documented assigned projects using the Microsoft To Do and Projectmanager.com
web applications to standardize project tracking and documentation.
*Conducted and maintained coordination, alignment, and time management for assay development projects under Senior
technical lead and Biochemists.
*Recorded project details such as task progress, resource limitation, material availability, and instrument flexibility to
streamline project requirements, budget, and timelines through Electronic Notebook in Azure DevOps.
*Assisted Senior technical leads and Senior project managers with design change, assay development including
verification, validation, and routine testing following written protocols to ensure project commitments remain on tracks to
complete key project deliverables.
*Facilitated meetings for scheduled action items and documenting meeting minutes to share progress with Core team
leaders and key stakeholders including discussion about progress of completing the current action items from
contributing members to ensure timely decision-making and effective communication between project stakeholders at all
levels.
*Tracking and documenting continuous dialogs with managers and stakeholders within Product development (R&D),
Analytical Development (Quality Control and Technical Operations), Regularity Affairs, Quality/Regulatory Compliance,
Manufacturing operations, Marketing, and Labeling departments to receive feedback and meet project requirements.
*Conducted audits (FDA/internal audits) of laboratory procedures/testing flow processes to identify potential areas
needing improvements and ensuring all company environmental, health, and safety policies, procedures, and guidelines
are followed to maintain safe workplace.
*Conducted R&D Bench-top and Antibody/Conjugate pilot work to execute product development strategies.
*Experienced in calibrating and testing products on analyzers including ETS, 30-R, V-Twin, VIVA E and Pro-E, AU640,
ADVIA 1800/2400, Kryptor, Dimension EXL, and Atellica.
*Utilized SAP, LIMS, Azure DevOps, ELN systems for technical projects and verification testing as needed for research
and data analysis.
*Applied scientific and statistical principles inside and outside of laboratory to accomplish variety of technical applications
for in vitro diagnostic (IVD) assay development and working with potentially Biohazardous materials including serum,
plasma, urine, and blood.
*Proficient in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat and PdfEditor.
*Experience in testing with Verification and validation activities, ANOVA, Quality by design etc. *Review and approves risk
assessments and ensures all required information is accurately completed as a risk coach.
*Knowledgeable in compliance standards with Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and
other regulatory governing entities and Good Manufacturing and Laboratory practices (cGMP/cGLP/cGDP) including 21
CFR Part 11, 210, 211.
February 2018-October 2021
Quality Technician 4
Siemens Healthineers
Newark, Delaware, United States
*Documented and executed detailed test plans and test cases and summarized and logged audit findings for reporting
purposes.
*Assisted in non-conformance and corrective action programs (CAPA) and lead investigations for OOS results and
deviations.
*Monitored field-level performance and reported on status and potential improvements through research and root cause
analysis (RCA).
*Developed and audited practices, programs, and reporting system metrics for optimal efficiency.
*Determined root cause of deviations and non-conforming results and implemented appropriate corrective and
preventive actions throughout product development process.
*Drafted technical documents such as deviation reports, testing protocol and trend analyses.
*Performed routine maintenance and calibration on testing equipment prior to product testing and troubleshooting.
*Maintained routine inventory tracking to avoid testing interruption and product backorders.
*Assisted technical operation seniors to monitor testing timelines to avoid commercial delays and compromised product
quality.
*Responsible for scheduling and documenting product testing and material/instrument availability with collaboration of
Manufacturing, Quality Analysis, and planning team to ensure deadline commitments are met.
*Interpreted test results by comparing to established specifications and control limits, making recommendations on
appropriateness of data for release.
*Reviewed, updated, and maintained all specifications, work guides, and SOPs to ensure quality.
*Conducted research and gathered information to analyze and present reports, charts, graphs, and other supporting
documents for data analysis on various technical assignments to identify opportunities for improvement and development
of the assay.
November 2015-February 2018
Manufacturing Technician 3
Pharma Tech
Newark, Delaware, United States
*Prepared standard operating procedures, manufacturing batch records and productivity reports.
*Tested products for functionality or quality and troubleshot problems with equipment, devices, or products.
*Built reagents/calibrators/controls and monitored and adjusted production processes or equipment for quality and
productivity.
*Inspected finished products for quality and adherence to customer specifications.
*Calibrated machines to maintain required productivity levels and adherence to quality standards.
*Prepared reports and technical documentation of day-to-day production processes.
*Examined incoming materials and compared to documentation for accuracy and quality.
*Experience in testing and troubleshooting for assay development and optimization on all SYVA/ADVIA analyzers.
*Supported other functional teams for procedure updates, process development, and technical investigations.
2015-04 2015-11
2016-08 2019-01
March 2014-January 2015
Manufacturing Technician 2
Pharma Tech
Newark, California, United States
*Prepared standard operating procedures, manufacturing batch records and productivity reports.
*Set up and verified functionality of safety equipment.
*Calibrated machines to maintain required productivity levels and adherence to quality standards.
*Made sure that products were released on time and are of good quality.
*Enhanced data gathering, extraction and analysis for diverse workflows and procedures.
*Supported functional teams such as Quality control, Planning, R&D, etc.
*Assisted in Analyzer conversion, control systems and value assignment projects.
*Experience in using SYVA/ADVIA Analyzers through testing and troubleshooting products.
April 2013-July 2013
Receptionist/Business Office Assistant
Genesis Healthcare
Keene, New Hampshire, United States
*Answered central telephone system and directed calls accordingly. Managed multiple tasks and met time-sensitive
deadlines.
*Confirmed appointments, communicated with clients, and updated client records.
*Answered phone promptly and directed incoming calls to correct offices. Greeted incoming visitors and customers
professionally and provided friendly, knowledgeable assistance.
*Answered large volume of incoming calls daily to resolve customer issues and schedule appointments.
*Kept reception area clean and neat to give visitors positive first impression.
Clerical Assistant
Kelly Service With TD Bank, Brattleboro, VT
*Reviewed time sheets, prepared attendance reports and processed payroll for office staff.
*Provided clerical support, addressing routine and special requirements. Produced high-quality communications for
internal and external use. Tracked and analyzed expenses for department's funds and budget and submitted updated
reports.
*Restocked supplies and submitted purchase orders to maintain stock levels.
*Interacted with customers via phone and email to provide information.
*Composed sensitive, confidential reports, and documentation.
EDUCATION
-2012
Bachelor of Science
Temple University
Philadelphia, Pennsylvania, United States
2012-02
Bachelor of Science: Biochemistry
Temple University - Philadelphia, PA
Biochemistry
SKILLS
Quality Control Black Belt PRO-E Siemens Analyzer Calibration Manufacturing Technician
Root Cause Analysis SIX Sigma Certification Test Plans Product Testing Calibrating Control Systems
Laboratory CGMP Documentation Documenting Technical Documentation SOPS
Manufacturing Operations Maintenance Scheduling GMP Assay Development Plasma Antibody
Batch Records Clinical Trials ADME Vitro Biochemistry Test Cases Quality Analysis
Product Development Marketing Analysis Data Analysis Marketing Market Trends Audit Audits
Internal Audits Budget Best Practices Contracts Metrics Shipping Staffing Time Management
Operations Azure Devops Analysis of Variance Anova SAP LIMS Inventory Purchase Orders
Corrective and Preventive Action CAPA Process Development Corrective Action Risk Assessments
Closing Escrow Loans Underwriting NON-Conforming Finance Business Analysis FDA
Customer Account Regulatory Compliance Healthcare Clerical Office Assistant Organization Skills
Receptionist Schedule Appointments Invoices Customer Service Oriented Customer Service
Incoming Calls Clerical Support Payroll Process Improvement Recruitment
Customer Service Representative Retail Sales Acrobat Adobe Acrobat Excel Microsoft Excel
Microsoft Powerpoint Powerpoint Microsoft Word
CERTIFICATIONS
Advanced Reporting and Analytics Certificate
Clinical Trials Management Certificate
Business Analysis Certificate
Advanced Concepts Certificate
Essentials Certificate
LANGUAGES
Gujarati - Intermediate Hindi - Intermediate English - Intermediate
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