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    Senior Quality Assurance Analyst - Fort Worth, United States - eTeam

    eTeam
    eTeam Fort Worth, United States

    3 weeks ago

    eTeam background
    Description

    Top 2 Must Haves:

    Method Validation Experience

    HPLC Experience

    Preferred:

    Compendia Experience

    Job Description:


    • Ensure that lab cleanliness and safety standards are maintained.


    • Develop and qualify new testing methods.


    • Train other analysts to perform laboratory procedures and assays.


    • Perform visual inspections of finished products.


    • Participate in internal assessments and audits as required.


    • Identify and troubleshoot equipment problems.


    • Evaluate new technologies and methods to make recommendations regarding their use.


    • Serve as a technical liaison between quality control and other departments, vendors, or contractors.


    • Coordinate testing with contract laboratories and vendors.


    • Write technical reports or documentation such as deviation reports, testing protocols, and trend analyses.


    • Write or revise standard quality control operating procedures.


    • Supply quality control data necessary for regulatory submissions.


    • Receive and inspect raw materials.


    • Review data from contract laboratories to ensure accuracy and regulatory compliance.


    • Prepare or review required method transfer documentation including technical transfer protocols or reports.


    • Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines.


    • Participate in out-of-specification and failure investigations and recommend corrective actions.


    • Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols.


    • Investigate or report questionable test results.


    • Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.


    • Identify quality problems and recommend solutions.


    • Evaluate analytical methods and procedures to determine how they might be improved.


    • Complete documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms.


    • Calibrate, validate, or maintain laboratory equipment.


    • Compile laboratory test data and perform appropriate analyses.


    • Conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.

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