Quality Assurance Control

LINH N.K. NGUYEN

**** ********* *****, ***. * ● Charlottesville, VA 22901 ● 434-***-**** ● *****@********.***

PROFESSIONAL EXPERIENCE

Phthisis Diagnostics, Inc. Charlottesville, VA

Research & Development Manager 2013 – Present

Managed three product lines simultaneously for 18 molecular diagnostic products in compliance with

the company’s ISO 13845:2003 Quality Management System (QMS).

Compiled, maintained, and updated Design History Files for all projects. Assisted the Regulatory

Director in obtaining CE mark clearance.

Supervised the R&D team through product development cycle from prototype development to

manufacturing integration and commercialization.

Developed, implemented and troubleshot quality control (QC) and quality assurance (QA), and

manufacturing procedures. Evaluated test results pertaining to all projects.

Coordinated activities between R&D, QC, and manufacturing to fulfill orders within tight deadline

and budget requirements.

Minimized customer complaints by identifying the causes or process inadequacies and by proposing

and implementing corrective and preventive actions (CAPA), including revision of product

specifications, production workflow, and QC procedures.

Senior Project Lead 2011 – 2013

Designed, developed, and optimized an in vitro diagnostic PCR-based assay detecting three human

infective parasites simultaneously within a 6 month deadline. Worked actively with the clinical team

to design clinical study protocols and CRFs in preparation for FDA 510(k) submission.

Developed effective standard operating procedures (SOPs) for laboratory and manufacturing to

ensure the highest quality products in adherence with the cGMP standards.

Transferred three prototypes to large-scale manufacturing. Established validation requirements for

pilot production lots and proposed modifications to make scale-up production more feasible.

Organized periodic reviews of QMS documents, internal quality audits, and vendor audits.

Prepared Design Control documents for each project in accordance with FDA 21 CRF 820.

Project Lead 2009 – 2011

Gained proficiency in Perl programming and bioinformatics tools to verify and validate a prototype

genomic analysis algorithm.

Fulfilled all proposed objectives of the awarded NSF grant in 6 months with minimal supervision.

Maintained accurate and precise technical records in both physical and electronic lab notebooks.

EDUCATION

B.S., Biomedical Engineering, University of Virginia May 2009

Team Finalist Runner-Up in the Undergraduate Research and Design Symposium.

M.E., Engineering Management, Old Dominion University Expected 2014

SKILL SETS

Clinical Studies, FDA, QMS, Quality Control, Quality Assurance, cGMP, Technical & Customer

Support, Product Design and Development, Problem Solving and Analysis, Project Management

Laboratory: PCR, nucleic acid extraction, microscopy, cell culture, assay development.

Computer: Java, Perl, MathCAD, Matlab, Minitab, MS Office, Adobe Photoshop.

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LINH N.K. NGUYEN

1902 Inglewood Drive, Apt. D ● Charlottesville, VA 22901 ● 434-***-**** ● *****@********.***

PATENTS

“Nucleic Acid Extraction from Complex Matrices”, US Patent. No. 13/028,712. Crystal R. Icenhour, Brian

V. Loyal, and Linh N.K. Nguyen.

“Molecular Standards for Microbial Pathogens”, US Patent. No. 13/930,486. Crystal R. Icenhour, Tyler

Hartley, Brian V. Loyal, and Linh N.K. Nguyen.

“Quantitative Diagnostic Test for Detection of Infective Parasites”, US Provisional Patent. Crystal R.

Icenhour, Linh N.K. Nguyen, and Laura Sahnow.

“Nanofibrous Scaffolds with Microencapsulated Cells for Tissue Regeneration”, US Provisional Patent. Linh

Nguyen, Margaret L. Rush, Yihwa Yang, Edward A. Botchwey, Adam J. Katz, and Roy C. Olge.

POSTER PRESENTATIONS

Nguyen, L.N.K., Loyal, B.V., & Icenhour, C.R. (2010). Comparison of Genomic DNA and Synthetic DNA

as Molecular Controls for Cryptosporidium and Giardia. Poster session presented at the General Meeting of

American Society for Microbiology. San Diego, CA.

Cochran, J.F., Nguyen, L.N.K., & Icenhour, C.R. (2011). Development of a Novel, Multiplex Real-time, PCR

Assay for Detecting Microsporidia. Poster session presented at the General Meeting of American Society of

Microbiology, General Meeting. New Orleans, LA.

Nguyen, L.N.K., Sahnow, L.A., & Icenhour, C.R. (2012). Comparison of E-Sphere® Simple NA Kit and

CDC Method for Intestinal Parasites. Poster session presented at the Annual Meeting of Association of

Public Health Laboratories. Seattle, WA.

Nguyen, L.N.K., Sahnow, L.A., & Icenhour, C.R. (2012). Use of Molecular Standards as High Quality PCR

Controls for Parasites. Poster session presented at the International Workshops on Opportunistic Protists.

Tarrytown, NY.

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