• QC Analyst II

    Job Locations US-MA-Bedford
    Posted Date 3 weeks ago(6/26/2018 10:10 AM)
    Job ID
    2018-1086
    # of Openings
    1
    Category
    Quality
  • Overview

    Execute quality control activities as assigned by management, including analysis of drug samples by liquid chromatography. Work with project team members to support release of drug delivery platform products. Initiate stability studies for drug products and coordinate sample storage with vendor. Manage product retain storage with vendor. Participate in method transfer activities, the maintenance and troubleshooting of laboratory equipment, and coordinate outsourcing of testing with vendors.

    Responsibilities

    • Manage and coordinate drug product stability studies
    • Coordinate storage and retrieval of stability samples with outside vendor
    • Write protocols and reports for stability studies that comply with USP and ICH guidelines
    • Manage retain program for released product batches and coordinate storage with outside vendor
    • Prepare and analyze samples according to established QC test methods
    • Perform chemistry testing using laboratory equipment and instruments (pH meter, analytical balance, pipettes, HPLC/UPLC, Karl Fischer coulometer, etc.)
    • Maintain laboratory notebook with contemporaneous laboratory work and results
    • Analyze testing results and write analysis reports
    • Schedule calibration of instrumentation on a routine basis
    • Troubleshoot equipment and coordinate repair with vendors as necessary
    • Troubleshoot test method issues and work with Quality Assurance (deviations, investigations, out of specifications, etc.) as required
    • Perform method transfer activities with analytical development to establish methods with QC
    • Coordinate with supervisor on scheduling of testing reagents and products
    • Coordinate external outsourcing and testing with vendors

     

    Qualifications

    • Bachelor’s degree in Chemistry or related field
    • 3-7+ years’ work experience
    • HPLC / UPLC experience
    • Product stability program experience
    • Knowledge of CFR 210,211, USP and FDA/ICH guidance
    • Operation in a GMP, GDP, GLP industry experience
    • Knowledge of safe laboratory practices
    • Strong oral and written communication skills

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