• LFB USA - QC Scientist I

    Job Locations US-MA-Framingham
    Job ID
    2018-1328
    # of Openings
    1
    Category
    Quality Assurance/Quality Control
    Type
    Full Time
    Company
    LFB USA
  • Overview

    Responsible for supporting the QC function in terms of method validation, transfer of analytical processes to CMOs, writing and reviewing protocols, change controls and SOPs, and assisting with testing for stability, in process and release of samples.

    Responsibilities

    • Execute QC analytical protocols, document results and investigate deviations.
    • Write standard operating procedures (SOPs), protocols, reports, deviations and memos.  
    • Play key roles in all QC validations and CMO transfers.  
    • Work with outside vendors to coordinate testing, purchase of new equipment, troubleshoot existing assays.
    • Support all quality systems
    • Be involved in life cycle management for methods, validations, and equipment.
    • Assist in bringing new technology and equipment into the QC lab.
    • Perform routine process, release and stability testing to support the manufacturing process.

    Qualifications

    • BS in Chemistry or Biochemistry with a minimum of 3-5 years pharmaceutical experience.
    • Understanding of the QC environment and GxP procedures is required.
    • Familiarity with chemical analysis methodologies, including chromatography, spectrometry, gel electrophoresis and ELISA.
    • Experience with ICH method validation practices.
    • Excellent writing capabilities.
    • Ability to work independently with good judgement and strong organizational skills.
    • Must communicate well and exhibit a high level of professionalism.
    • Excellent problem solving skills.
    • Results oriented.

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