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    • Associate Scientist, Quality - Rockville - MESO SCALE DIAGNOSTICS, LLC

    MESO SCALE DIAGNOSTICS, LLC
    MESO SCALE DIAGNOSTICS, LLC Rockville

    6 days ago

    Default job background
    Full time
    Description

    Position Summary: An Associate Quality Scientist is responsible for independently managing the testing, technical transfer, and troubleshooting of protein-based immunoassays. This position plays a critical role in addressing failing product, documenting failures appropriately and determining an appropriate path forward.

    Duties and Responsibilities:

    • Review testing data and perform analyses including investigations of failures, as well as process and product performance trending and monitoring.
    • Provide descriptive statistical analysis using clear and concise methodologies and ensure accuracy and validity of data.
    • Conduct experiments, summarize results, and present recommendations to cross-functional teams including senior management.
    • Lead Material Review Board (MRB) meetings and facilitate discussions.
    • Initiate, coordinate, and/or be the Technical Lead of CAPA documents (Deviations, Non-Conforming Material Report (NCMR), etc.).
    • Establishes and monitors direct report performance and development goals, assigns accountabilities, sets objectives, establishes priorities, and provides continuous feedback and recognition on performance.
    • Identify process and product improvements using product data and metrics as a guide.
    • Ensure testing and process documentation complies with MSD processes. Develop, revise and implement Standard Operating Procedures (SOPs), Test Records, and product specification documents, as required.
    • Participate in general lab organization including inventory and equipment management and support 5S compliance.
    • Ensure application of laboratory safety precautions and proper use of personal protective equipment.
    • Specific duties may vary based on departmental requirements.

    Experience and Qualifications:

    • Bachelor's degree and 2 years of experience in relevant field is required.
    • Additional education may be substituted for experience.
    • Additional experience may be substituted for degree.

    Knowledge, Skills and Abilities:

    • Strong understanding of protein-based immunoassays and technique.
    • Knowledge of protein-based immunoassays execution, development, and optimization is preferred.
    • Knowledge of laboratory safety precautions and proper use of personal protective equipment.
    • Ability to troubleshoot immunoassays and reagents using logical problem solving and root cause analysis.
    • Knowledge of Design of Experiments (DOE) is preferred.
    • Demonstrated aptitude for learning and applying new techniques and methodologies.
    • Understanding of basic molecular biology techniques and their application.
    • Leadership skills with demonstrated knowledge and understanding of staff management practices and processes. Ability to establish accountabilities and expectations and manage performance to achieve results
    • Ability to prioritize and manage multiple, complex tasks in a fast-paced environment under tight deadlines.
    • Excellent oral, written communication and interpersonal skills are required.
    • Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of laboratory data.
    • Proficiency in MS Office suite.
    • Basic knowledge of standard data analysis tools and databases.
    • Familiar with Matlab, MiniTab or other statistical software analysis tools is preferred

    Physical Demands:

    • This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job and move about the office.

    Work Environment:

    Standard office environment.

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