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Quality Control Analyst - LCMS Expert

Company: Agilent
Location: Boulder
Posted on: August 4, 2022

Job Description:

To protect the health and safety of our employees, contractors, customers and communities, employees in the U.S. and Puerto Rico are required to be fully vaccinated against COVID-19, unless an approved exemption has been granted for a medical reason, sincerely held religious belief, or an employee is otherwise exempt under applicable law.

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at .

Job Description:

  • Conducts routine, non-routine analyses and review to support LCMS testing for oligonucleotide sequence confirmation, quantitative impurities and related impurities according to Standard Operating Procedures (SOP) and Analytical Methods in accordance with current Good Manufacturing Practices (cGMPs) and regulatory requirements.
  • This position will be primarily focused on support for LCMS testing using quantitative impurity, sequence confirmation and related impurities procedures.
  • When not working on LCMS analyses/projects, this position may also help with technical issues in the QC laboratory.
  • Performs equipment and lab maintenance tasks including:
    • Routine calibrations and System Suitability Testing
    • Maintenance of lcms reagent stocks
    • Actively engages in continuous improvement of processes and procedures.
    • Proven ability to exercise judgment and appropriately escalates issues to QC management.
    • Executes quality control procedures using Agilent LC/MS and HPLC systems. LCMS procedures include: MS/MS oligonucleotide sequence confirmation, quantitative impurity analyses & assays, impurity characterizations.
    • Calibrate and maintain Agilent 6500 series Q-TOF and Agilent 6100 series single quad. LCMS systems
    • Primary responsibility will include preparing & running samples on an lcms system along with processing and reviewing Quantitative LCMS & MS/MS sequence confirmation data.
    • Conduct minor repairs to LC/MS and HPLC equipment
    • Ensures equipment is performing well and communicates and takes appropriate action as necessary.
    • Outstanding communication skills, both written and oral, and will be expected to communicate directly with project managers and management.
    • Conducts analysis associated with clinical and commercial under current Good Manufacturing Practices (GMP) regulations and guidance per Food and Drug Administration (FDA) and Organization for Economic Co-Operations and Development (OECD) as well as International regulations.
    • Performs analysis on raw materials, in-process materials, APIs (developmental and commercial), final product and other requested testing as per written procedures.
    • Reviews data for compliance to specifications and reports and troubleshoots abnormalities.
    • Required to follow good documentation practices.
    • Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. The salary range for this position is currently $89,680.00 - $140,125.00

      Benefits in Brief

Keywords: Agilent, Boulder , Quality Control Analyst - LCMS Expert, Professions , Boulder, Colorado

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