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Enthusiastic Analytical Chemist eager to pursue a lasting career in the pharmaceutical industry.
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Olivet Nazarene University - Bourbonnais, IL
GPA:3.0
Quickly developed and validated three pharmaceutical detergent-cleaning validation method for FDA response during annual FDA inspection in march 2012.
Asahi Kasei America – Charlotte, NC,
- Performing qualitative and quantitative analysis of raw material, finished product, stability, process validation,and cleaning validation sample-using analytical instrumentation such as GC, UPLC, HPLC, TLC, UV/VIS Spectroscopy, pH metry analysis, particle size analysis, Karl Fischer, FTIR, wet chemistry, etc.
- Performing the analytical method evaluation, method development, method validation(Linearity, Recovery, Specificity, LOD, LOQ, Forced degradation, Precision, etc.) and method transfer of excipient, raw material, finished product, cleaning agent and cleaning validation of carryover from previously run product on pharmaceutical equipment.
- Experienced in method validation protocol writing, method validation report writing, method transfer protocol writing, method transfer report writing, and analytical method writing.
- Writer, publisher and reviewer of pharma ready system.
- Have in depth knowledge of chromatographic analysis such as tailing factor, resolution, peak purity, purity angle, purity threshold, capacity factor, theoretical plate count etc. of chromatographic peak. As a professional chromatographer, troubleshoots the instrumentation, method development challenges and routine LIR investigations.
- Auditing/Reviewing the routine analytical work such as QC release, stability testing, method validation, cleaning validation performed by other analyst.(peer review)
- Maintaining all training and trainer record using compliance wire learning management system.
- Having fundamental understanding of GxP, ICH guideline, cGMP’s/GLP’s and USP/NF compendial monograph.
- Serving on a laboratory committee such as safety, suggestion, cGMP, SOP and news latter.
- Maintaining laboratory notebook as per the FDA regulation and cGMP requirement.
- Performing other duties as assigned such as product technical package and specification evaluation.
Johnson Matthey – Downingtown, PA,
- Performed finished product and stability sample testing using HPLC, UV/VIS spectrophotometric analysis.
- Performed blend uniformity, assay, content uniformity, residual solvents, dissolution, TLC, IR, and water determination of finished product and stability samples.
- Performed all job responsibilities in safe and efficient manner.
- Released product before dead line.
- Trained other personnel in analytical instrumentation, test methodology and auditing the analytical work.
- Performed LIR investigation as needed. Followed corrective action and preventing action to eliminate the cause of non-conformities.
Ani Pharmaceuticals – Boston, MA,
● Drove success by analyzing in-process and raw materials, lot release, complaint samples, and wet chemistry materials, reporting production metrics to laboratory supervisor.
● Improved documentation by composing and reviewing deviations for laboratory suspect analytical results and events in Trackwise (CAPA).
● Optimized communications through conducting a monthly multi-laboratory safety compliance audit and composing related paperwork and correspondence.
● Enhanced data management by constructing deviations, nonconformances, CAPAs, complaints, and out-of-specification analyses in Trackwise.
● Streamlined lab activities by maintaining a general lab environment, including pipette verification, equipment logbook inspections and HPLC troubleshooting.
● Increased efficiency via serving as a bench analyst, second person reviewer/verifier, and analytical investigator..
Academic Project:
Processing and refining crude oil- at Gas Authority of India:
- Evaluated the performance of the fully automated plant consisting of distillation, cracking, treatment, and reforming-processes.
- Optimized the Liquefied natural gas process at minus 160 degree centigrade.
Database Design- at SIOM college:
- Designed library database management software using oracle.
Computer:
- Software: Microsoft word, Excel, PowerPoint, Empower, Chemstation.
- Programming Languages: Visual Basis, UNIX, C, C++, Data structure using C.
- Operating Systems: Windows 98/NT, UNIX, Macintosh, Windows XP, Vista.
Training:
- Phenomenex- HPLC Method Development Certification, ChromSource-Gas Chromatography Certification, Waters: Apex Track Integration Certification.
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School Attended
- Olivet Nazarene University
Job Titles Held:
- Analytical Chemist
- QC-Chemist
- QC Chemist
Degrees
- Bachelor of Science
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