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Quality Control Analyst III

Location: Cambridge
Posted on: May 13, 2022

Job Description:

  • Minimum of 4 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
  • Demonstrated technical writing and validation knowledge is required The person who secures this role will:
    • Implement laboratory equipment and enterprise/local software systems
    • 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

Keywords: WHITRIDGE ASSOCIATES INC, Cambridge , Quality Control Analyst III, Professions , Cambridge, Massachusetts

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