Lien Ly Email & Phone Number

Santa Monica, Ca

Led and managed a quality team to conduct the product release process to support new product launches, reorder production and supply chain. Managed the testing laboratory operation where heavy metals and trace contaminants were analyzed to support company mission for clean products. Maintained and improved quality system to ensure that products were produced following GMP/GLP/GDP guidelines and meeting regional regulatory. Oversaw the company quality management system from SOP training, Change Control, Non-conformance/Deviation, CAPAs, quality agreements, CM audit, and Annual Product Review. Managed stability program and testing requirement for product launches, shelf life establishing, and claims. Collaborated with cross-functional departments of R&D, Product Development, Packaging Designer, Regulatory and Operations to support product specification setting, Fill & Assembly Specification publishing, and SOP/guidelines issuance.

Torrance, Ca

Led and managed a plant quality team to support the production process to ensure that all products meet consistent standards from incoming inspection, product testing, in-line production inspection, and final release disposition. Trained and managing production line staffs in Good Manufacturing Practices and quality assessments of goods. Developed, revised, and managed Standard Operating Procedures from issuance to training. Monitored and facilitated investigations for non-conformances and customer complaints. Participated in external and internal audits including facilitating, supporting, addressing CAPAs and closing out.

Torrance, California, United States

Led and supported analytical chemists for conducting physical and chemical tests, while monitoring production rate, improving stability program, and overseeing R&D projects. Developed and implemented analytical test methods for analyzing active ingredients, vitamins, and nutritional ingredients. Reviewed and updated R&D and QA/QC standard operating procedures and test methods. Handled all aspects of stability program from new product development to new product launches and marketed products. Spearheaded the management of R&D analytical / stability laboratory to support product releases, out of specification investigation, preventative maintenance and annual calibration for instruments.

Chatsworth, California

Supervised analytical chemists to perform chemical testing to support production, stability programs, and R&D (product development). Implemented the new Chromatography Data Software (CDS) – CHROMELEON. Issued several Quality Assurance (QA) Laboratory standard operating procedures (SOPs) and test methods to improve lab efficiency and compliance. Provided technical support to raw material testing. Authored technical reports/justification to support non-conformance (NC) investigations and other quality related. Trained analytical chemists and technicians in analytical methodology, laboratory safety and compliance. Implemented cGMP, GLP and GDP guidelines on laboratory activities. Performed troubleshooting for instrumental issues / failures, laboratory investigations. Performed chemical testing for product release. Coordinated laboratory activities to ensure product released in timely manner.

Greater Los Angeles Area

R&D Analytical Lead for new product launches and site transfers to both internal and external cGMP manufacturing sites:o Develop, validate, and transfer of stability-indicating HPLC test methods o Experience with APIs, impurities and degradants; cleaning test methods; and preservativeso Manage CRO for test method development, test method validation, and test method transfers o Author and approve Analytical documentation to meet regulations for product launches o Stability: stability study strategy development, protocols, testing, reports, and expiration dating o People management of laboratory technicians and contractorso Cross-functional collaboration with Business QA, Plant QA & QC, Project Management, Product Development, Technical Transfer, Regulatory, Packaging to resolve Analytical product launch issuesInternal Plant Support:o Provide Analytical guidance on Laboratory Investigations (LIRs), Investigations (INVs), and CAPAso Execute cycle time reduction projects to increase QC Lab efficiencyo Support FDA plant audits and internal audits with no R&D Analytical related 483 observationsExperience with USP General Chapters: o <3> (Product Quality Tests for Topical and Transdermal Drug Products)o <232> (Elemental Impurities)o <467> (Residual Solvents)o <476> (Organic Impurities in Drug Substances and Drug Products)