THUY NGUYEN

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

Lawrenceville, GA. 30043

678-***-****

ac0cah@r.postjobfree.com

Accomplished Quality professional with 10+ years of experience in medical and research laboratories. Detail-oriented and accurate professional with solid accomplishments and experience supporting manufacturing and quality assurance policies and procedures as well as process validation for medical device company. Strong track record of maintaining highest quality standards, controls, and regulations to enable efficient and timely releases of medical products and providing best-in-class customer support to various cross-functional, internal and external customers. Knowledge of tooling, test equipment and good laboratory practices.

AREAS OF EXPERTISE

Specialized skills in the collection, processing, and management of quality and inspection-related documentation, records, and data.

In-depth, practical knowledge of quality system regulations, industry regulations and standards such as FDA, USP, ISO and USDA.

Advanced research, analysis, troubleshooting, problem solving, and testing abilities.

Excellent customer service, team collaboration, and communication talents.

Advanced technical aptitude with computer proficiency utilizing: MS Word, Excel and Access.

KEY PERFORMANCE INDICATORS

Attention to Detail

Collaboration

Problem Solving

Critical Thinking

Consistency

Poised under Pressure

Quality Driven

Reliability

Time Management

Training

Managing Multiple Priorities

Hands-On

Planning

Prioritizing

PROFESSIONAL EXPERIENCE

GLOBUS MEDICAL, INC. 07/16-5//17

Quality Control Technician

Daily review and approval of Steam and EtO sterilization runs to ensure each runs meets requirements and subsequent of sterilized materials to be used in manufacturing.

Daily check and review of all Logs( including, but not limited to, cleaning logs, temperature, Magnehelic monitoring and tissue destruction) to ensure compliance with all procedures

Maintain Medical charts for donor batch records.

Perform in-house testing(including but not limited to DBM and Cortical Fibers batch testing).

Perform all Quarterly Monitoring Program (including, but not limited to Tissue Dose Audits, Environmental Monitoring and Personnel touch plates for the processing facilities and processing personnel).

Observe processing cases in real time to ensure product meet specifications; perform technical review of processing paperwork. ID any deficiencies and follow up with appropriate processors to ensure accuracy and completeness.

Interface with QA to ensure compliance with all procedures.

Trend and review the Environmental data results.

Daily review of production donor case packets and file in the folders.

QUALITY BIORESOURCES, INC-Seguin, TX 12/14-07/16

Quality Assurance Technician

Assist in formal training for employees.

Monitor all departments in quality matters. Report any discrepant, out-of- specification results to the Manager immediately. Assist the Manager with internal audits.

Perform first article, in-process and final inspection of product.

Receive the raw materials and verify the COC/COA from the suppliers and release raw materials to production.

Daily monitoring of temperatures for freezers, coolers and incubators.

Daily review of batch records to ensure timely release of finished product for shipping.

Perform line clearance for filling and packaging. Release product to the next stage of processing including ensuring that the previous stage has been completed.

Ensure follow-through of corrective actions.

Perform the DI water and non-viable particle counts testing in ISO 6, ISO 7 and ISO 8.

ORGANOGENESIS, INC.- Canton, MA 07/06-09/14

Quality Control Analyst II- Microbiology Laboratory

Conduct Environmental Monitoring for Class 100 Dynamic, 100K, 10K and FortaFlex; including reading plates and excursion reporting, water testing and Bioburden testing.

Perform the Endotoxin testing for finished product using the Gel-clot and Pyros Kinetix method.

Perform the in-process Sterility testing using 3D/Alert BacT system and raw material testing using the USP method. Perform the Growth Promotion for media fill.

Coordinate the Gowning Qualification for new-hire employee and requalification. Facilitate gowning qualification program.

Coordinate activities with outside labs for Mycoplasma testing.

Perform Gram-stain for the environmental monitoring plates.

Proficient in Aseptic technique.

Maintain the laboratory and ensure the laboratory is cleaned. Understand and follow the manual SOPs and Quality Manual.

Key Contributions:

Ensure incoming documentation and data complies with Document Control Policies and Procedures.

STD Med, Inc. - Boston, MA 01/05-07/06

Quality Control Inspector I

Support quality assurance functions for medical tech company.

Conduct analysis of Limulus Amebocyte Lysate test for medical devices.

Conduct Environmental Monitoring working in CleanRoom. Verify and ensure completeness of certifications, tests, and quality inspection data; confirm material/goods meet specifications required by purchase order, work order.

Conduct dimensional checks using micrometer, vision center, verinier and comparator.

Examine products before and following return from outside service operation.

Key Contributions:

Consistently ensure complex and detailed documentation is complete and accurate.

Excel in role requiring strong attention to detail, multi-tasking, and organizational skills.

EDUCATION

Mass. College of Pharmacy - Longwood, MA

Bachelor of Sciences in Pharmaceutical Sciences.

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