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Quality Control Project

Location:
United States
Posted:
July 08, 2010

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Resume:

Summary of Skills

High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Liquid Chromatography in tandem with Mass Spectrometry (LC/MS) and Gas Chromatography in tandem with Mass Spectrometry (GC/MS) analysis of pharmaceutical compounds via extraction from biological matrices

HPLC and GC analysis of pharmaceutical products during production and stability studies

Data acquisition, processing and finalization using Millennium, Analyst, Oracle Assist and LabWare

Manage project day to day progress: sample analysis, reagent preparation, data finalization, data generation, troubleshooting

QC review of HPLC, GC, micromass, LC/MS and GC/MS data, project notebooks, reports and tables

Train associate personnel in extraction techniques, instrumentation, troubleshooting and data review

Comprehension and enforcement of SOPs in a GLP and GMP laboratory setting

Final report generation for submission to clients

Experience with Lean Labs, Red Belt in Six Sigma

Experience

09/07-present Wyeth Pharmaceuticals, Richmond, VA (Became Pfizer in 10/09)

QC Scientist II, Analgesic/Respiratory Primary Packaging Unit (ARPPU) Laboratory

Responsible for analyzing samples for release and stability studies using HPLC and GC. Prepared samples via dilution prior to analysis. Responsible for all instrumentation set up and troubleshooting during analysis. Responsible for learning GMP and the department SOPs. All daily work was documented in laboratory software along with all data generated. Programs used included LabWare and Millennium LIMS. Conducted investigations on Out of Specification (OOS) and atypical results. Conducted peer review on data for other analysts. Obtained Red Belt in Six Sigma

11/98-09/07 PPD, Richmond, VA

8/05- 09/07 ASSOCIATE GROUP LEADER (CHROMATOGRAPHIC SCIENCES DEPT.)

Responsible for the day-to-day activities of direct reports. Conduct numerous studies simultaneously, meet deadlines, ensure quality, review all chromatography and data generated by junior staff, communicate with clients, and ensure overall productivity for all studies. Serve as a resource for my team in troubleshooting instrumentation, extraction procedures and overall understanding of day-to-day activities. Responsible for presenting junior staff with new assignments, training junior staff and evaluating progress with new techniques. Participate in weekly scheduling meetings to evaluate current workload and bimonthly meetings with management to evaluate department progress and needs. Responsible for data generation and submittal to QA and subsequently, the client.

2/03-8/05 SR. SCIENTIST – QUALITY CONTROL (BIOANALYSIS)

Reviewed project data, notebooks and designed the department quality control process. Assisted in final bioanalytical report preparation. Responsible for communication with department managers or group leaders concerning assigned projects and provide updates on progression or problems. Reviewed and approved notebook entries made by junior staff.

6/01-2/03 SCIENTIST (CHROMATOGRAPHY and MASS SPEC)

The following duties are in addition to the Associate Scientist duties: plan and organize work with minimal supervision; provide assistance and training to Associate Scientists; set up and maintain analytical data in regards to acceptability and consistency; problem solve, either independently or with assistance, extraction and/or instrumentation problems. Analyze samples via HPLC and LC/MS.

8/00- 6/01 ASSOCIATE SCIENTIFIC WRITER (MASS SPEC)

Designed tables and figures for presentation of data prior to writing analytical report, interpreted computerized data output to develop text for analytical reports, and compiled raw data and statistical summaries from laboratory database into a client specified format. Ensured that hard copy and electronic reports are consistent and complied with required formats.

11/98-8/00 ASSISTANT AND ASSOCIATE SCIENTIST (MASS SPEC)

Responsibilities in this role were as follows: extract biological matrix samples to determine the levels of analytes of interest; read, comprehend and carry out laboratory activities according to Standard Operating Procedures; perform daily work assignments accurately, timely and in a safe manner; conduct extraction procedures following written method or instructions; learn routine operation, maintenance and theory of analytical instrumentation; communicate project status to project leader; maintain laboratory/project notebook as required by the Standard Operating Procedures.

1997-1998 Wyeth Ayerst Pharmaceuticals, Richmond, VA

ANALYST, Packaged Products Stability

Responsible for analyzing samples for process validation, cleaning validation, stability studies using High Performance Liquid Chromatography, Gas Chromatography, Conductivity, Atomic Absorption, Spectrophotometry and Moisture Determination. Prepared samples via dilution or extraction prior to analysis. Responsible for learning GMP and the department SOPs. All daily work was documented in laboratory notebooks along with all data generated. Programs used included Microsoft Excel and Word.

Education

Virginia Commonwealth University, Bachelor of Science, Chemistry, 1997

Alpha Phi Omega, National Co-Educational Service Fraternity, Charter President, Alpha Delta Iota Chapter, Virginia Commonwealth University

Other Qualifications

Team Leader, PPD Safety Team, 2002-2007

Team Participant, PPD Training Improvement Team, 2004-2005



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