• Manage QMS system to ensure regulatory and ISO 17025 compliance.• Oversee all quality-related processes including internal audits, document control, training, nonconformities, deviations, CAPAs, complaints, risk management.• Implement 5S practices to improve process flow.• Initiate data trending practices. Use control charts to monitor performance of various processes.

• Implemented and maintained eQMS software QT9 for multiple sites. Ensure ISO/GMP compliance. • Managed training records, customer complaints, CAPAs, change controls, document control, equipment qualifications.• Identification of possible failures in testing and manufacturing processes. Investigate and resolve failures through root cause analysis. • Design, execute and write validation protocols and reports. • Lead role for internal, customer and regulatory audits. Hosted customer visits.• Oversee vendor qualification program, new supplier sources. • Created master equipment list and maintained calibration and PM schedule.• Manage and provide mentorship to quality staff. Communicate priorities and allocate work to meet production and customer timelines.• Reviewed batch records for material release.• Design and implemented data tracking system to evaluate data trending. Created statistical process control charts, batch correction efficiency and sample tracking..• Authored and updated SOPs, work instructions and test methods.

• Completed test method development and validations per USP <1225> and ICH Q2 using GC, HPLC and UV-Vis.• Managed interdepartmental project to obtain secondary supplier of key raw material. Evaluated performance and safety of final product per ISO 11979-2,3,5 and ISO 10993-1. • Authored and updated SOPs, work instructions and test methods.• Coordinated hazardous and universal waste accumulation and disposal for all departments. Responsible for handling waste shipments and ensured adherence to appropriate 49 CFR standards.• Lead the chemistry safety team. Implemented incident reporting structure and corrective actions to reduce future incidents.• Reviewed batch records for material release.• Trained new hires on laboratory test methods, safety procedures and GDPs. • Maintained lab results database and used statistics to support drafting material specifications.

• Instructed undergraduate-level chemistry students on general chemistry principles relevant to the laboratory experiments. • Held office hours to provide additional tutoring services.• Ensured all safety procedures were known and understood before work began.

• Performed on-site pickup of hazardous waste including the separation, labeling, and packaging of chemicals per DOT regulations.• Maintained positive customer relationships through strong communication and flexibility.

Developed techniques and protocols for studying how DNA interacts on surfaces using a combination of confocal microscopy and atomic force microscopy.

In Dr. Ye's lab I used nanografting to research self-assembled monolayers on gold substrates using atomic force microscopy.