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Quality Control Scientist III Resume Example

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QUALITY CONTROL SCIENTIST III
Professional Summary
Skills
Work History
Pfizer Inc- Quality Control Scientist III
Andover , Massachusetts 08/2019 - Current

• Analytical testing of in-process, intermediate bulk, and drug product (recombinant protein, monoclonal antibodies) • GMP cell culture of mouse bone marrow stromal cells (W20), human umbilical venous endothelial cells (HUVEC), HEK293, U937
• Analytical testing of in-process, intermediate bulk, and drug product (recombinant protein, monoclonal antibodies) for biological activity and stability
• Cell-based assays assessing cell proliferation, growth inhibition, apoptosis inhibition
• Recording all related data in compliance with cGMP and quality procedures
• Record keeping utilizing LabWare Laboratory Information Management System or biological activity and stability
• Cell-based assays assessing cell proliferation, growth inhibition, apoptosis inhibition
• Recording all related data in compliance with cGMP and quality procedures
• Record keeping utilizing LabWare Laboratory Information Management System

Vericel Corp.- Quality Control Analyst, Senior
Cambridge , MA07/2018 - 08/2019
  • Perform QC testing in a cGMP lab for raw material release, final product/in process testing and process qualifications using PCR based methodology and Cell Culture Methods.
  • Perform finished product review and lot release.
    Conduct data analysis of testing results, and review data obtained for compliance to SOP and specification.
  • Transfer methodology from other groups and maintain complex equipment.
    Author reports, SOPs and other documentation for quality testing.
  • Provide training and technical leadership to less experienced staff.Participate in and perform laboratory investigations and non-conformance deviations.
  • Participate in the execution of corrective and preventative action plans as well as the initiation and follow through for change controls.
  • Provide data review of test records and generate Certificate of Analysis (COA).
  • Generate and manage deviations, investigations, CAPA, and change controls.
Shire Pharmaceuticals - Quality Control Analyst II
Lextington, MA06/2014 - 07/2018
  • Perform immunoassay and biochemical assays (Fibronectin Binding Assay, western Blot, SDS-PAGE Coomassie, Proliferation Bioassay and Substrate Clearance Assay, etc.
  • Complete documentation in accordance with current Good Manufacturing Practices (cGMP).
  • Responsible for change controls related to QC operation such as decommissioned temperature chambers and new software updates for Instruments.
  • Maintain QC lab and related systems to ensure compliance with industry standards.
  • Management of laboratory equipment/instrument and systems to ensure compliance.Work within QC to maintain efficient compliant laboratory (equipment, documents, SOPs).
  • Practice safe work habits and adheres to company safety procedures and guidelines.
  • Establish, revise, review and maintain procedures (including protocol, Training Guides and technical report).
  • Monitoring of critical reagents, Assay Controls, Cell Banks and reference standards related to analytical, cell-based methods.
  • Experienced with QMS software such as Track wise, laboratory data management software LIMS, software for analyzing parallel line and parallel logistics assays PLA 2.1 and Enterprise software SAP.
  • Coordinate logistics in R&D environment, including ensure timely receiving and shipping of biological materials/samples from or to external collaborators, service providers and clients.
Shire Pharmaceuticals - Development Specialist
Lexington , MA06/2012 - 06/2014
  • Execute all cell-based assay platforms as a member of the Cell Biology group including cellular uptake assay and cell-based substrate clearance assays. These assays may be used to evaluate in-process samples for characterization purposes as well as for non-commercial stability testing and for method or process bridging studies.
  • Execute 96-well microtiter plate-based protein binding assays to support process development for early and late stage programs.
  • Responsible for qualifying all critical reagents required for assay execution in both Analytical and Quality Control Bioassay Groups, which include FBS, cell banks and antibodies.
  • Routinely author internal reports documenting critical reagent qualification and cell bank testing e.g. mycoplasma testing.
  • Support other analytical functional groups when needed in the Analytical Development Department to keep program progress moving forward; for example, executed the size exclusion HPLC test method to support program study over the course of 2 months.
  • Manage daily functioning of the laboratory including supply ordering and instrument maintenance, which enabled 100% work efficiency of fellow colleagues.
  • Perform in various qualification studies
Education
University of Massachusetts - LowellLowell, MAExpected in 05/2022Master of Science: Biomedical Engineering, Biotechnology
University of Massachusetts AmherstAmherst, MA06/2012Bachelor of Science: Biology
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Resume Overview

Companies Worked For:

  • Pfizer Inc
  • Vericel Corp.
  • Shire Pharmaceuticals

School Attended

  • University of Massachusetts - Lowell
  • University of Massachusetts Amherst

Job Titles Held:

  • Quality Control Scientist III
  • Quality Control Analyst, Senior
  • Quality Control Analyst II
  • Development Specialist

Degrees

  • Master of Science : Biomedical Engineering, Biotechnology
    Bachelor of Science : Biology

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