Quality Control and Quality Assurance, Data Review, Computer skills

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Wei (Vickie) Cui

Clarksville, MD *****

Tel: 443-***-**** (mobile phone)

Email: **********@*****.***

CAREER OBJECTIVE:

A motivated and dedicated professional with more than twenty-five years of experience in research development, method validation and transfer, quality control testing, data review and quality assurance seeks a Research Scientist / QC Data Reviewer / QC Scientist / QA Specialist role where I can develop and excel while giving my best to the employer. SUMMARY OF QUALIFICATIONS:

• 18 years’ experience in the pharmaceutical and BioTech industry working in Quality Control department, conducting HPLC, UPLC, GC, UV-Vis, FTIR, Dissolution, cIEF, BioA, qPCR, ELISA, SDS-PAGE, Western Blot, Cell Culture, ICP, Particle Size, Karl Fischer, Appearance, TOC, pH, Conductivity, Osmolality, Viscosity, Turbidity, and other Raw Material testing per USP methods, and QC data review.

• Multiple years’ experience with reviewing QC data for numerous types of assays. Authored, reviewed and approved invalid events, deviation, CAPA, change control, SOPs, work instructions and test methods. Have strong collaboration and communication skills with all teams in Quality Control, Quality Assurance, Document Control, MS &T, manufacture and facility department.

• Multiple years’ experience with method validation and transfer, writing SOPs, validation protocols, validation reports and test methods, executing the protocols, performing assays at validation, registration and development stages and facilitating document training.

• 2 and years’ experience as a research chemist with FDA/CVM with conducting method development and validation.

• Strong laboratory skills, working experience with state-of-the-art laboratory instruments such as LC/MS/MS, GC/MS, HPLC, UPLC, UV-Vis, FTIR, Dissolution, GC, BioA, qPCR, ELISA, SDS- PAGE, Western Blot, Cell Culture, Vi-Cell, CE, iCE3, AA, ICP, X-Ray Fluorescence, Karl Fischer, TOC, and Conductivity. Extensive experience with Chemstore / Chemstation, OpenLab, Empower, AccuSeq, SoftMax Pro, LIMS, Trackwise, Veeva for EQMS and SAP and other software.

• Great deal of experiences with the Smartsheet for collaboration, work management, assigning tasks, tracking project progress and sharing documents.

• Performed instrument IQ/PQ/OQ tasks.

• Extensive experience with FDA and EU regulations, ISO and ICH guidelines, and CGXP including CGMP, CGCP, CGLP and CGDP principles.

• 2 years’ experience as an assistant professor in a university in China.

• About 40 credit hour graduate level courses in inorganic chemistry/organic chemistry/advanced analytical chemistry.

• Well-organized, goal-oriented, diligent, attention to detail. PROFESSIONAL EXPERIENCE:

Lockheed Martin, Andover, MA, MTL team, 03/2024 –11/2024 Quality Control technician

• Performed basic specification testing such as conductivity, pH, density, turbidity, viscosity, and water activity testing on GridStar flow battery products.

• Performed UV-Vis concentration analysis using both automatic and manual set up instrumentation.

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• Performed HPLC and ICP analysis.

• Conducted result reporting in LIMS using both automatic data transfer from instrument software and manual input.

• Demonstrated strong trouble - shooting skills for both test methods and equipment.

• Revised SOPs and test methods. Contributed to improvement of test methods, procedures and result report in LIMS.

• Participated in method validation activities and periodic monitoring of chemical products to ensure that they meet customer specifications.

• Performed inventory of laboratory chemicals and supplies.

• Worked diligently and very productively. Generated high quality and accurate results. Emergent BioSolutions, Baltimore, MD, QC Department, 10/2020 –10/2023 Specialist I, QC Data Review

• Utilized a wide variety of analytical / biological / Compendia methodologies and techniques to perform detailed technical and data integrity review of complex QC data. Performed LIMS review using Sample Manager and Lab Vantage LIMS software. Reviewed all documentation and logbooks in accordance with governing procedures.

• Performed assay data review for HPLC with Empower 3 software, qPCR, ELISA, SDS-PAGE, Western Blot, Cell Culture, TOC, Conductivity, pH, Osmolality, Appearance, and other testing for in-process, product release, and stability samples daily in accordance with all protocols and procedures. Generated stability reports for external customers.

• Performed ELN review for environmental monitoring testing data, such as Endotoxin and Bioburden.

• Reviewed testing data in the manufacture suite for manufacture validation activities. Provided feedback on documentation on assay data forms and logbooks according to the CGMP and CGDP principles. Collaborated with Manufacture, AS & T and QA departments for successful validation of the projects.

• Contributed to troubleshooting / laboratory investigation efforts with QC and QA management. Investigated any concerns and discrepancies for the assay results and ensured appropriate actions were taken.

• Participated in revising SOPs, test methods, work instructions, assay data form. Worked as an author, process owner, reviewer, and approver for deviation, CAPA and change control documents using Veeva EDMS.

• Supported the QA Document Control team by improving workflow for the submission, review and archival of assay documents and logbooks to ensure GMP document safety and traceability.

• Provided training on QC data review and QA tasks to peers.

• Great deal of experiences with the Smartsheet for collaboration, work management, assigning tasks, tracking project progress and sharing documents.

• Wrote a comprehensive document for providing instructor lead training on Qualified QC Data Reviewer.

• Demonstrated very strong organizational and interpersonal skills and the ability to work collaboratively with all teams in QC department, QA and QA Batch Reviewers, AS&T, Manufacture, and facility departments.

• Reviewed large amount of SOP, work instructions, test methods, and assay data forms for writing comprehensive QC data flow diagrams for manufacture sampling procedures, QC analytical / bioassay, QC Sample Management, QC Stability Program, QC Micro, QC Raw Material, and Lab Vantage LIMS teams.

• Demonstrated strong abilities to work in a fast paced and highly regulated environment and adapt to multi-task and change of priorities.

• Received rewards from QC management and peers for high productivity, excellent performance and teamwork.

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AstraZeneca PLP, Frederick, MD, QC Department, 11/2011 –08/2018 Senior QC Analyst

• Conducted Reversed Phase-HPLC, HPSEC, HIC, IEX, UV-Vis A280, ELISA, CE, cIEF, BioA, QPCR, Vi-Cell, and GC testing for in-process drug substance, finished drug products and stability samples.

• Have extensive experience with Empower software.

• Strictly followed GMP, GLP, GDP, GCP and FDA regulations throughout my work. Conducted analytical testing in a very organized and timely manner and provided high quality and accurate results.

• Performed peer review for assay data.

• Led and performed method validation and transfer tasks for some projects. Authored, reviewed, and approved validation protocols, SOPs and validation reports.

• Coordinated complex projects with other departments such as Quality Assurance, MS&T and statistical team to accomplish objectives.

• Worked as a SME for iCE3 and GC instruments. Have multiple years of experience with instrument troubleshooting techniques for HPLC, iCE3, GC and other instrumentation.

• Participated in iCE3 and GC instrument IOQ tasks.

• Served as QC interface with MS&T on validation projects and with vendors for instrument service.

• Coordinated with manager to ensure successful investigation of exceptional conditions or atypical data.

• Utilized Trackwise system for non-conformance and OOS investigation activities. Wrote CAPA documents.

• Provided technical guidance and training to peers.

• Participated in lab ownership, monthly logbook review and lab safety inspection.

• Conducted reagent, instrument tools and parts inventory.

• Conducted 6S implementation for cIEF and GC benches in lab Q100, which saved labor, time, and resources. Obtained a yellow belt project certificate in 2017. Shire Pharmaceuticals, Inc., Owings Mills, MD, QA / QC Department, 10/2004- 11/2011 Chemist

• Conducted HPLC and UPLC analysis with Empower software, residual solvents testing using GC, Dissolution, Particle Size, Karl Fischer, Appearance, TOC, Percent Solid, and other Raw Material testing per USP methods. Performed data review, notebook/raw data archive, etc.

• Performed deviation, Out- of- Specification and Out-of-Trend investigations using Trackwise.

• Very proficient with writing and revising SOPs.

• Provided guidance and training to team members.

• Led method transfer for Vyvanse in the Pharm Analysis team for two years. Method transfer tasks included reviewing CMC documents; drafting SOPs, validation protocols, and test methods; executing protocols; conducting assays at validation, registration, and development stages; facilitating document training and conducting sample inventory.

• Conducted monthly lab safety audit to ensure a safe work environment. Was an active committee member - Plant Chemical Hygiene Committee. Pharmaceutics International, Inc., Hunt Valley, MD, Dissolution Group, 2/2004-10/2004 Chemist

• Conducted Dissolution and HPLC analysis for in-process and finished pharmaceutical products. Generated results in a timely manner with high accuracy and productivity. Ensured high clarity notebook records.

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Center for Veterinary Medicine, FDA, Laurel, MD 8/2000- 3/2003 Chemist

• Collaborated with a principal investigator in the validation of a method for determination of pentobarbital in dry dog foods by gas chromatography/mass spectrometry (GC/MS).

• Conducted a local survey of pentobarbital concentration in dry dog foods containing animal fat or meat and bone meal using GC/MS.

• Conducted the study for screening and confirmation of multiple drug residues in eggs by liquid chromatography/ion trap tandem mass spectrometry (LC/MS/MS).

• Developed multiple residue/multiple species methods to screen for drug residues in aquaculture products: shrimp using LC/MS/MS.

• Independently conducted analysis of Ceftiofur and Cephapirin in Bovine Milk using HPLC. Provided important information for division decision making regarding those two chemicals in milk products.

• In collaboration with colleagues, designed and developed a Microsoft Access based database for division chemical standards. The system allowed users to conduct queries about chemical standards and other specific purposes

Anshan Iron and Steel Institute, China. Dept. of Basic Sciences, 9/1989–5/1991 Assistant Professor

• Taught two undergraduate courses: (1) Analytical Chemistry, and (2) Technical English Reading.

• Supervised undergraduates in their thesis research. COMPUTER SKILLS:

• 25 years’ experience with MS Windows 2000/NT.

• 25 years’ experience with Microsoft Office (Word, Excel and PowerPoint).

• 2+year experience with database design, development, and management via Microsoft Access. EDUCATION:

• Graduate work in Analytical Environmental Chemistry George Mason University, Fairfax, VA

• Graduate work in Analytical Chemistry

Virginia Commonwealth University, Richmond, VA

• MS, Analytical Chemistry

Liaoning Normal Univ, Dalian, China

• BS, Chemistry

Liaoning Normal Univ, Dalian, China

PUBLICATIONS:

• Foster, G. D., Cui, V., PAHs and PCBs Deposited in Surficial Sediments along a Rural to Urban Transect in a Mid-Atlantic Coastal River Basin (USA). J. Environ Science and Health. Chem. 43:1333 (2008).

• Heller, D.N., Cui, V., Strategy for Confirming Multiple Classes of Animal Drug Residues in Eggs: Generic Solid Phase Extractions and Gradient Liquid Chromatography with Data- Dependent Electrospray-MS/MS on an Ion Trap Mass Spectrometer, 49th ASMS Conference on Mass Spectrometry and Allied Topics, Chicago, IL, June 2001.

• Heller, D.N., K. M. Lewis, V. Cui. Method for Determination of Pentobarbital in Dry Dog Food by Gas Chromatography/Mass Spectrometry. J. Agric. Food Chem. 49: 4597-4602 (2001).

• Nigam, S., A. de Juan, V. Cui, and S. C. Rutan, Characterization of Reversed Phase Chromatographic Stationary Phases Using Solvatochromism and Multivariate Curve Resolution, Anal. Chem. 71:5225 (1999).

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