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Pfizer Sr. QC Scientist
- 1. MALEEKAKAZMI (702)-625-3352 Maleeka.kazmi@pfizer.com http://www.linkedin.com/in/maleekakazmi QUALITY CONTROL SCIENTIST Withextensive experience and knowledge of Pharmaceutical and Biopharmaceutical Analysis and a passion to learn new Analytical Technologies and apply them to achieve the Departmental Quality Objectives. Resourceful, analytical and detail-driven Individual with capabilities in completing multiple projects in a Quality Control laboratory with competing deadlines. Strong team member, able to deliver on time results, while maintaining high safety methods, practices and GMP compliance. Knowledge and understanding of Biopharmaceutical Manufacturing, Industry Regulation (ICH) and GMP compliance including analytical method qualifications/validation/verification and method improvements and troubleshooting. Knowledge and understanding of regulatory filing process and experience in Laboratory Investigations. Clear communicator, both oral and written. Self-motivating and ability to adapt to rapidly changing project priorities. Strengths include: ● Regulatory and cGMP Documentation and Compliance (FDA, CFR guidelines) ● Quality Control (Raw materials, in-process, final, stability testing and method qualification, validation and improvements ) ● Instrumentation Troubleshooting/Diagnosis (including FTIR, UV/Vis, HPLC, GC and MS). Understanding and knowledge of NMR and MALLS. ● Investigations, Project Progress, Stability, OOT and OOS Reports ● Process Improvement including FMEA, 5S, KPI and DOE Project Management includingmethod transfer,method improvement and development projects. Ten years of experience with Analytical Technologies includingHPLC and UV. Trained in Pfizer procedures including: LIMS, QST, Empower Change Control, CAPA, CI Board Updates
- 2. ● Project Management(Including Microsoft PM and Visio Software) ● Active Pharmaceutical Ingredients (APIs) and Biomolecules Analysis ● Collaborate and consult effectively with cross-functional teams KEY ACCOMPLISHMENTS ● At Pfizer assisted with 96% on time disposition and completion of CI board project in raw materials lab. ● At Life Technologies assisted in method transfer and improvement for HPLC, ELISA and UV/Vis. ● At Regis Technologies reduced the report turnaround time from 14 days to 3 days in a GMP laboratory, as a result, the manager won the President’s award of that year. Prepared Stability reports for the previous two years. ● At Deibel Laboratories helped in expanding the Chemistry Business by developing in- house analytical testing methods (including HPLC and GC). One of the major results was that the report turnaround time was reduced from 21 days to 5 days which lead to attracting more customers. PROFESSIONAL EXPERIENCE Pfizer, Andover MA - Quality Control (Contract position) September 2016 –January 2017 ● Perform Compendia USP/JP/EP testing on raw materials and enter results in LIMS. ● Execute compliance audits for the raw materials lab. ● Assist in Continuous Improvement projects by completing action items and updating metrics for the CI board. Project Manager/ Continuous Education November 2010- September 2016 ● Managed budget, online portfolio and performed estate planning. ● Attended Seminars, took online courses to better understand the Pharmaceutical Industry business. Life Technologies, Bedford MA- Quality Assurance/Control October 2008 -November 2010 ● Collaborated with R&D for method transfer, validation, qualification and published weekly status reports/meeting minutes for ongoing quality projects. ● Utilized Lean manufacturing tools to achieve organization goals and objectives. 0 10 20 30 Jan-05 Jan-06 In-house method development to reduce report turnaround time. Days 0 2 4 6 8 10 12 14 16 Testingcomplitiontime(days) Dates … Reduction in Report Turnaround Time Series1 Series2
- 3. ● Consulted R&D,Facilities & Engineering, and Manufacturing for troubleshooting and investigations. Regis Technologies, Morton Grove IL - QC Chemist May 2007 - August 2008 ● Initiated deviation reports for Out of Specification (OOS) results. Assisted the manager in assessing and analyzing deviations, identifying root cause and implementing CAPA. ● Assisted in initiating, planning, executing and reporting results for Stability and Reference Qualification projects in a GMP facility. Prepared Stability Reports. ● Performed Operation, Maintenance and Calibration for HPLC, GC, KF, UV/VIS, Particle Size Analyzer and FTIR. Performed testing using Mass Spectrometry. ● Performed testing for Analytical Methods validation projects. Deibel Laboratories, Lincolnwood IL - Chemist / Microbiologist May 2005 - August 2008 ● Performed cross-functional duties, including Microbiology and Chemistry Testing, Quality Control and Assurance, R&D and others, as required by business needs. ● Developed methods for GC, HPLC and AA using USP and AOAC. Avlon Industries, Melrose Park IL - Chemist May 2003- August 2004 ● Oversaw batch chemical processing via scale-up & batch adjustments (pH, viscosity, color fragrance, active ingredients etc.) for personal care products. ● Performed formulation and stability testing for final products. Authored reports for marketing department. Accugen Laboratories, Clarendon Hills IL - Microbiologist May 2003- August 2004 ● Performed media preparation, plating and other testing and reporting results. EDUCATION Universityof Illinois at Chicago - BS January 2000 - May 2003 Analytical Chemistry, Cell Biology, Biochemistry, Microbiology. Northern Illinois University - Graduate Courses August 2004 - May 2005 Advanced Biochemistry, Advanced Analytical Chemistry, Water Microbiology, Mycology. Continuous Education 2011-September 2016 Project Management, Bioprocessing, Biomanufacturing and Pharmaceutical Technology. TECHNOLOGY Word, PowerPoint, Excel, Access, Outlook, MS Visio and MS Project, Agilent Chemstation, UNICORN, Minitab, Empower, SAP, LIMS.