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quality control chemist i resume example with 7+ years of experience

Jessica Claire
  • Montgomery Street, San Francisco, CA 94105 609 Johnson Ave., 49204, Tulsa, OK
  • Home: (555) 432-1000
  • Cell:
  • resumesample@example.com
  • :
Professional Summary
  • Excellent experience in the Pharmaceutical and medical device field with a strong analytical background along with broad-base knowledge of instrumental analysis.
  • Efficiently managed testing of generic drugs in tablets, capsules,soft gels,injections,suspensions using analytical instruments.
  • Experience performing analysis of Finished product, in-process,Stability,Raw Materials,Packaging materials as per in-house,USP,ACS and JP methods.
  • Analyzed and troubleshoot wide range of technical problems that caused delays significantly increasing daily outputs.
  • Excellent knowledge of Pharmaceutical analysis and Good Laboratory Practices.
  • Special skills in instrumental analysis like HPLC,Dissolution apparatus (Distek), UV(Shimadzu), FTIR(Shimadzu), KF(Mettler), PSD (Sonic Sifter), TLC.
  • Willing to relocate: Anywhere and Authorized to work in the US for any employer
Skills
  • Biology and Chemistry
  • Laboratory Equipment maintenance
  • Genetics and Molecular Biology
  • Packaging processes
  • Pharmacology
  • Safety policies
  • HPLC,FTIR,TOC,UV,Dissolution Apparatus
  • Process Validation,Cleaning validation
  • Instrument Calibration
  • Inventory auditing and Purchasing coordination
  • Practiced in LIMS Software
Work History
Quality Control Chemist I, 05/2019 to Current
Bio-Rad LaboratoriesWoodinville, WA,
  • Ensure compliance with all company policies and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, CMDR and the Medical Device Directive
  • Performed instrumental (i.e., UV-Vis, HPLC) and wet chemistry techniques/analyses
  • Perform laboratory testing, as well as general laboratory maintenance, including in process and final product release testing and stability testing.
  • Ensure timely testing and result reporting.
  • Submit samples for shipment to third party labs when necessary.
  • Maintain GMP/GLP laboratory notebooks and Good documentation Practice relevant to the duties and responsibilities assigned.
  • Maintain laboratory instrumentation required for testing
    Assist as needed in test method validation, implementation, and execution
  • Calibrated Balances,pH type of equipment on daily basis and documented readings and adjustments to improve equipment accuracy.
  • Monitored consumable laboratory supplies and replenished inventory to enable timely completion of testing activities.
  • Performed standard and proprietary physical testing and chemical analysis of raw chemical materials and finished products.Reported any equipment and testing deviations to the Supervisor.
  • Assist with proper execution of laboratory Out-of-Specification (OOS) investigations
  • Complete data entry for trending reports for In-process and Finished Goods Quality Control Testing,
    as well as Stability Testing
  • Train team members in Analytical department as assigned.
  • Handle and dispose of biohazard material in compliance with OSHA and Standard Operating procedures
  • Demonstrate organizational and time management skills.Perform other related duties required
Quality Control Chemist, 01/2017 to 04/2019
Danimer ScientificGates, NY,
  • Analysis of Finished product, in process, Stability Samples of Tablets, Capsules, Powder by following SOP, USP Method and In-house Test Methods.
  • Analysis of Process Validation and Method Validation Samples.
  • Performed Analysis of stability samples Assay, Content Uniformity, Dissolution, Dissolution Profile, Water content, Identification Test, And Also Generated Process Validation Reports.
  • Dealing with Uses and Destruction of Control Substance as per DEA requirement.
  • Performed Water Content by KF Titrator and ID Test by FTIR,UV.
  • Performed Disintegration Test by Disintegration Test Machine.
  • Performed Bulk Dencity, Tapped Dencity, Particle Size Distribution by sonic sifter-Retsch Seiving Machine.
  • Cleaning Verification and Cleaning Validation Samples Analyzed by HPLC and UV.
  • Analyzed Rinse Samples by TOC analyser.
  • Performed TLC Test Using TLC Plate.
  • Determined Analysis Priorities, Organized Work Load, Complated Analysis in Timely Manner.
  • Trained on Empower-3 Software for Operation and Data Evaluation.
  • Maintained Column Records and Inventory.
  • Used LIMS to Submit Analyzed Result.
  • Analyzed and trouble shoot Wide range of Technical problems that caused delays significantly increasing daily outputs.
  • Performed Calibration of Laboratory Equipment's including Balance, pH meter, Conductivity meter, Karl-ficher Titrator, UV, FTIR, Coulorimeter.
Quality Control Chemist, 02/2015 to 12/2016
Danimer ScientificBel Air, KY,
  • Perform physical and chemical analysis of raw materials, packaging material, in-process, and finished pharmaceutical products, including products on stability, according to written methods, material specification, and company policies as identified in standard operating procedures (SOPs).
  • Perform process validation and cleaning validation/verification testing on various drugs.
  • Assist other scientists with analytical instruments and Use sonic sifter, Karl Fischer, UV-Vis spectrophotometer, Infra-red spectrophotometer, HPLC with UV detection as well as with conductivity detection, TLC, pH meter, and dissolution.
  • Comply with cGMPs, SOPs, and STPs to avoid out-of- specification situation.
  • Assure compliance with state and federal regulations.
  • Document steps followed during analysis execution, calculate and report results.
  • Actively participate in investigation of laboratory results.
  • Review laboratory analysis data for completeness, specification compliance and for SOPs.
  • Report any abnormal findings to the Supervisor.
  • As assigned, perform in-depth review of analytical records/reports to assure that calculations & other data are technically correct and compliant to relevant specifications.
Internship Student, 01/2013 to 01/2014
Zydus CadilaCity, STATE,
  • Hands on Training for Testing a in-process samples and formulation processes of tablet for Hardness, friability, disintegration.
  • Managed quality assurance program, including on-site evaluations, internal audits and customer surveys.
  • Resolved manufacturing problems, improved operations and provided exceptional consumer support.
Education
Certificate of Pharmacovigilance in Advanced Drug Safety: , Expected in 07/2016 to Sollers Collage of Advanced Drug Safety - Edison, NJ,
GPA:
: Biotechnology, Expected in 2011 to Sardar Patel University - Gujarat,India,
GPA:

Molecular Biology, Microbiology, Cell Biology and Genetics, Microbial biotech, Microbial Genetics, Animal biotech, Microtechniqes.

Master's: Pharmaceutical Chemistry, Expected in 2009 to Sardar Patel University - Gujarat,India,
GPA:

Green chemistry, Pharmacology, Drug design And Development, Medicinal chemistry, Advanced physical chemistry, Modern Analytical techniques.

Certifications
  • Certified Associate in Project Management (CAPM)
  • First Aid/CPR Certified
  • Certified Pharmacy Technician (CPhT)
  • Certificate of Advanced Drug Safety and Pharmacovigilance
,

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Resume Overview

School Attended

  • Sollers Collage of Advanced Drug Safety
  • Sardar Patel University
  • Sardar Patel University

Job Titles Held:

  • Quality Control Chemist I
  • Quality Control Chemist
  • Quality Control Chemist
  • Internship Student

Degrees

  • Certificate of Pharmacovigilance in Advanced Drug Safety
  • Master's

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