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Click here or scroll down to respond to this candidateCandidate's Name
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Ph: # (C): PHONE NUMBER AVAILABLEEmail: EMAIL AVAILABLEOBJECTIVE:Looking for to leverage my education, knowledge and experience in to a role for an Analytical Science and compliance area.SKILLS:QC Compliance, CAPA Management, Cost Reduction, Investigation, Root Cause Analysis, Laboratory Analysis, Analytical Reports, Clinical and Instrumentation expertise, Independently Method development and validation to get an approval of CAP, CLIA, NJ DOH under LDT. Analytical, QC and QA experience in CAR-T. Method development and validation for Metals, UDT, Pharmacology, Botanical, and other raw materials in GMP, USP, EPA, ASTM methods. Beckman coulter DXC 700, DXI 800, DXH, AU 480, AU680. Siemens ACL Tops, Sysmax, Vista, CentaurPROFESSIONAL EXPERIENCE:Feb 2024 Current Rober Wood Johnson (RWJ-BH)Night shift - Clinic Lab Technologist/ Lead TechConduct hands on sample processing in area of Chemistry, Hematology, Coagulation, Manual Diff., Urine analysis, Microbiology.Releasing results on timely and accurately while maintaining TAT 93% or more. Interpret test results (more than 200 + tests) and generate reports for healthcare providers (EPIC).Work closely with healthcare professionals to interpret findings, troubleshoot issues, and provide timely and accurate laboratory information.Ensure compliance with quality control measures and regulatory standards in all laboratory procedures.Perform various laboratory tests and analyses on patient specimens, including blood, urine, and other bodily fluids.Call for critical results and ensure no sample contamination.Conduct daily Cal, QC and maintenance for day and 2nd shift to have a smooth work flow.Ensure to meet TAT, schedule personal to makes sure 365 days fully staffed to run effective. Work very closely with lab personal and provide them proper training.Inventory control, Lot to Lot validation, maintenance, to keep up to date and maintain compliance documents to ensure CAP, CLIA, NJ DOH inspection ready. Upgrade SOP and other compliance documents, if necessary.Achievements: Implemented cost reduction and reduction of TAT by 18minReported any abnormal findings promptly to the concern staff.April., 2022 - Current Bristol Myers Squibb, BMS, SummitSr QC ComplianceDaily work on QC compliance deviations of CAR-T tests. Fastest learner and received lots of appreciations as Bravo points from QA, Lab managers and other associates departments.16% more deviation completed compared to other teammates and 100% deviation closed on time, Thanks to QA and Lab staff helping me to achieve the success in short time.Gain knowledge and experience with cGMP manufacturing, Quality, and Compliance. Capable of providing input and Builds relationships internally within and with cross functional teams.Improved deviation TAT by 38% providing proper feedback to initiators.Excellent knowledge of competence in quality processes, including but not limited to material disposition, deviations, investigations, and CAPA management etc.Actively participate in project like CAR_Ts related SOP and Training materials for new hires.Implemented cost reduction about $300K and reduce TAT by 2.5 daysReview and complete lab deviations document steps followed during analysis execution, calculate and report results. Actively participate in investigation of laboratory results.Support, documents and collaborate with multiple departments to ensure timely closer of all types of Deviations including OOO, OOT, RCA (root cause analysis). Assist QA for closure of all investigations.Review laboratory analysis data for completeness, specification compliance, and compliance with companys written policies.Report any abnormal findings to the Supervisor. As assigned, perform in-depth review of analytical records/reports to assure that calculations and other data are technically correct and compliant to relevant specifications.Feb 2017 April 2022 Sunrise Clinical Reference Lab, IrvingtonLab ManagerPerforming daily analysis of various samples of Blood, Serum, Plasma, and Urine using complex method and procedures using instrumentation like AA, ICP for metals and ABSciexs MS, Shimadzu LC, Perikn Elmers GC etc for Drug confirmation under LDT (Lab develop test)Daily QC, maintenance and troubleshooting of instruments like AA, ICP, LC-MS, HPLC, GC and other wet analysis instruments like Dissolution, KF, pH, etc.Independent work on method development using strong technical, analytical and instrumentation skills and able to perform routine and non-routine maintenance independently.Oversee staff, their daily day to day work, determine the priorities, scheduling, etc. Oversee technical performance assuring accurate results and optimal turnaround time.Excellent skill in performing and analyzing any tests and making sure results are accurate.Prep, calibrate, validate QC, Control, and other std to ensure it met DOHs requirement. Maintain Quality Control, Quality improvement and Proficiency Testing.Reviewing Drug confirmation daily results, verify, approve and send report to LIS/LabGen.Validating instruments, new methods and tests to get an approval from CDC, DOH. Developing new test and method for THC, Testosterone, Vitamins, Alcohol (EtG, EtS), Oral Fluid, Pain panel drugs, Bath Salts, Metals like Hg, As, Pb.Ensuring compliance of all logistic parts and record keeping with NY/NJ - DOH/EPA certification, CLIA and CAP inspections. Establish and implement policies and procedures in collaboration with associated departments throughout the organization.Responsible performing analytical drug testing data. Review and analysis of all LCMS confirmation results to ensure the accuracy and integrity of the drug testing process, and subsequently releasing these test reports to LIS/LIMSPerforming analysis of various samples and raw materials using complex work methods, practices and procedures by using SOP, EPA, GMP, RCRA, OSHA and ASTM.Set goals and metrics for performance, monitor employee productivity and provideconstructive feedback and coachingApril 2011 Feb 2017 Accureference Medical Lab. LindenToxicologist /AnalystPerforming daily analysis of various samples of Blood, Serum, Plasma, and Urine using complex method and procedures using instrumentation like AA, ICP for metals and ABSciexs MS, Shimadzu LC, Perikn Elmers GC etc for Drug confirmation.Prep, calibrate, validate QC, Control, and other std to ensure it met DOHs requirement. Maintain Quality Control, Quality improvement and Proficiency Testing.Reviewing Drug confirmation daily results, verify, approve and send report to LIS/LabGen.Setting up LIS systems as and when necessary if new test added or any change in QCEnsuring compliance of all logistic parts and record keeping with NY/NJ - DOH/EPA certification, CLIA and CAP inspections. Establish and implement policies and procedures in collaboration with associated departments throughout the organization.Responsible performing analytical drug testing data. Review and analysis of all LCMS confirmation results to ensure the accuracy and integrity of the drug testing process, and subsequently releasing these test reports to LIS/LIMSAssist and interact with other departments such as Sales, Customer service, Purchase contract, proper billing and IT/LIS to ensure correct interface.Handling multiple tasks with an accuracy in a fast-paced technical environment. I strived for maximum utilization of available time, equipment, and laboratory resources through multi-tasking.Performing analysis of various samples and raw materials using complex work methods, practices and procedures by using SOP, EPA, GMP, RCRA, OSHA and ASTM.Maintain and ensure all procedures are performed per SOP and in compliance with regulatory agencies.Oct., 2008 July, 2011 EPA Certified Lab for Metals, VOCs, Oil, PCBs, Wet Chemistry.Lab. Analyst/Quality- ChemistDaily QC, maintenance and troubleshooting of instruments like AA, ICP, GC, Mass Spectro, Titrator, FP, pH, KF, BTU, Distillations, Wet Chemistry etc.Performing analysis of Metals by ICP, Volatile Organics by GC, semi-volatile organics by GC/MS. I analyzed oil, grease, water, waste water, soil and other complex chemical samples and wastes.Analyzing PE, EPA, OSHA samples for lab certification. My team exceeded accreditation requirements.Chemical, physical and wet chemistry analytical skill.Inputting data from analysis into lab information database like LIMS. I completed all logs and records related to analysis for traceability. I compiled and reported analytical results to supervisor.Labeling samples throughout the preparation steps and documentation of results. I worked independently and followed all SOPs, GMPs and safety policies.Preparing EPA and Lab samples for physical and wet chemistry. I performed different catalyst and analytical procedures as per Standard method or any other written or verbal method.Calibrating instruments and preparing stock solutions as required.Working safely under laboratory rules, procedures, and good practices. I worked well in a team environment - and willing to assist in other areas. I maintained laboratory notebook.EDUCATION:MS in Science (Evaluation WES, and TES College, Trenton, NJ) April - 1994AFFILIATION:America Chemical Society (ACS), AATCC, SOFT, CAPEligible for CLIA/CAP/AMT/ASCP/NY states certification.EXPERT:Beckman coulter DXC 700, DXI 800, DXH, AU 480, AU680Siemens ACL Tops, Sysmax, Vista, CentaurTrinity HgbA1c * Iris and Autionmax for UrinalysisLCMS - ABSciex and Shimadzu platformHand on expert using and maintaining instruments like HPLC, GCMS, ELISA, ICP-MS, LC-MS, TOC etc |
