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Quality Control Analyst

Company: LanceSoft, Inc.
Location: Norton
Posted on: June 25, 2022

Job Description:

Title: Quality Control Analyst IIILocation: Norton, MADuration: 06+ Months (Possible Extension) Job Description:Duties:The Analyst III, Quality Control will help in the implementation of laboratory equipment and enterprise/local software systems at Company's GMP laboratories in Norton, MA supporting drug substance manufacturing. This position will be heavily focused on Laboratory Equipment Qualification, Implementation of a LabWare LIMS system, and validation of QC computerized systems. Demonstrated technical writing and validation knowledge is required.

  • Execute qualification activities, including analytical equipment qualification per USP . Experience and demonstrated knowledge of analytical systems and software to support lab system implementation.
  • Contribute to LabWare LIMS system implementation through performance of master data build, validation execution, and setup for QC within established project timelines.
  • Validate QC computerized software systems associated with laboratory instrumentation in accordance with 21 CFR Part 11 and EU Annex 11. Collaborate with IT Validation group to ensure all deliverables are met and comply with Company procedure.
  • Author technical documentation (e.g. SOPs, protocols, test scripts, reports, etc.) with guidance commensurate with experience.
  • Ensure adherence with applicable SOPs, compendia, and in accordance with company and regulatory agency policies and procedures. Skills:
    • 4 - 6 years of experience in a GMP laboratory or software validation setting
    • Experience with QC analytical instrumentation and software systems (UPLC / UPLC-MS, Karl Fischer, FTIR, TOC, spectroscopy, etc.)
    • Knowledge of analytical equipment qualification per USP , and software validation in compliance with 21 CFR Part 11 and EU Annex 11 are desired
    • Experience with LabWare LIMS and design/implementation is ideal Education:
      • B.S. in applicable science field

Keywords: LanceSoft, Inc., Brockton , Quality Control Analyst, Professions , Norton, Massachusetts

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