STEVEN NGUYEN

*** *********** ***.

Wake Forest, NC 27587

919-***-****

acwdmj@r.postjobfree.com

Highlights:

Experienced in Laboratory QA/QC analysis and testing and Quality System support.

Have a working knowledge of ISO 9001, FDA Regulations, OSHA Standards, Sterile Clean Room Procedures, and cGMP.

Released Product using TrackWise, Livelink, LIMS, SOP, PeopleSoft, ETQ, QMS, and SAP, using the structures and knowledge of policies and practices of manufacturing/medical device processes.

Work Experience:

Quality Specialist- Batch release, Biomerieux, Durham, NC, April 2016 – present

Review Batch Records on multiple production lines and QC ( Biochemistry) technical data for accuracy and compliance with cGMP prior release in SAP and LIMS

Verify open NCMRs and current document revision for finished batch in Doc-link and TrackWise system

Support quality investigation activities, customer complaints, and CAPAs

Report and Track DHRs errors for continue improvement per target yearly goal

Quality Technician, Corning Incorporated Life Science division, Durham, NC, Nov. 2007 to April 2016

Corning Incorporated completed the acquisition of the majority of BD’s (Becton, Dickinson and Company) Discovery Labware (medical devices division) business November 1, 2012.

Review Batch Records (DHRs) using cGDP (Good Documentation Practice) guidelines and disposition pre and post finished batches in SAP, PeopleSoft, and EtQ to Sterilizer and shipping Department

Shift coordinator for product releases, quality issues, and notification advisor (quality noncompliance issues)

Investigate, review, and approve all pending notifications and issues for resolution and batch release in a timely manner.

Conduct random Stat Sampling inspections using ANSI Z1.4 sample plans and trend defects per million (DPM). Report DPM findings to quality, production and continuous improvement ( CI ) departments.

Conduct quality test on incoming raw materials for production use.

Monitor, trend and analyze non-conforming data from MES using Statistic Process Control (SPC) and chart data utilizing Minitab and Excel statistical analysis tools to reduce waste per department

Create, review, edit, and approve Quality Standards( medical devices product level I, II ), and SOPs in the Document Management System (QDMS)for production associates.

Train production associates on current versions of Quality Standards, Everest SAP, EtQ reliance for NCMs

Support Quality Engineer in resolving noncompliance issues and customer’s complaints through investigation of root cause analysis.

Support Quality Engineers (QE) in the testing and data collection during PQ of validation projects

Conduct quarterly internal audits on production.

Conduct Quality/Safety/5S meetings to discuss and implement corrective and preventative actions( CAPA) to enhance customer satisfaction and control and minimize defects.

Support QE on conduct quality methods to improve production associates skills using Six Sigma techniques such as MSA (Measure System Analysis) to test capability and repeatability.

Quality Control/ R & D Technician, IPS Corporation, Durham, NC, Jan. 2002 to Oct. 2007

Performed QC final stage for all structural series adhesives and activator products using lab equipment such as: Brookfield DV-II Viscometer, Yokogawa DX106 graph station, Haa-1 hot and cold water bath; make batch adjustment to insert product to meet QC specifications using SPC charts.

Reviewed all production batch records for documentation compliance and disposition finished batch in SAP

Tested and Analyzed selected incoming raw materials using UV, ISO 9001 guidelines and adjusted product batches to meet R&D specifications.

Assisted in experimental projects for scale up, involved mixing and weighing chemical components in 2- and 15- gallons tanks, make experimental adhesive bonds for physical testing, monitor all stages of testing adhesives in a controlled environment and record all raw data.

Coordinated all updated Certified Analysis and MSDS for incoming raw materials, performed production batch records for accuracy, performed biweekly PM on experimental machine for testing

Generated production graphics and reports from data analysis of raw data monthly using MS Excel and Word

Research & Development Technician, Lab Support at OMG AMERICAS, RTP, NC, Oct. 2000 to Dec. 2001

Performed metallurgraphic evaluation of a variety of samples, monitored products in temperature chambers for reaction, conducted corrosion testing of samples, powder evaluation for client companies using high tech machines including Satec System, Lindberg Furnace, high-beam microscope, Rotap, Rockwell Hardness Tester, and transverse tester, polishing and chemical edging machine.

Developed new and improved existing products via testing such as: milling, characterization, compacting and sintering.

Wrote and evaluated reports of test results, read blueprint diagrams for troubleshooting equipment.

Worked in Specialty Technology for auto industry- performed a variety of lab experiments using tube furnaces, viscometer, dispermate, overhead mixer, temperature control water bath, and microscope.

Created different types of chemical vehicles and pastes by following SOP’s and used MS Excel to record raw experiment data into computer logbooks.

Reliability Technician, Adecco Technical at Alaris Medical Systems, Inc. Creedmoor, NC, Aug.2000 - Oct.2000

Operated a variety of laboratory and electronic test equipment for stability testing

Performed dimensional, visual, and functional testing of raw products following specific diagrams

Conducted testing, gathered information, calculated test data, and reported test results

Utilized spreadsheets and word processing applications to document work

Cell Culture Technician, Biogen, RTP, NC, Sept.1999 – March 2000

Monitored different stages of cell growth in 100L to 2000L bioreactors using T1000 automated system

Performed cell transfer to different spinner flash vials and monitored incubation stages

Ran automated cell counts for viability and density

Performed validation test runs on protocols using blueprint diagrams and SOP’s

Performed daily testing of standard buffer and acid levels, cleaned sterilized hood, reviewed batch records and logbooks

Quality Assurance Technician, Staffing Alliance at GlaxoWellcome, Zebulon, NC, Summer Co-op 1998

Sampled, inspected, and tested all finishing packing products on production line.

Performed auditing of batch records and work stations according to SOP’s.

Education:

Associate in Science (AS), Industrial Pharmaceutical Technology, Wake Technical Community College, Raleigh, NC

Related courses: chemistry, analytical chemistry, pharmaceutical chemistry, microbiology, cGMP regulation, process validation, process quality control, pharmaceutical processes control, online ASQ training and certification.

References available upon request

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