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Rahway

    CSV/QA Engineer - Rahway, United States - Xyntek, Inc

    Xyntek, Inc
    Xyntek, Inc Rahway, United States

    3 weeks ago

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    Contract
    Description

    About us

    Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processes—globally—with a sophisticated blend of products, technologies, and lifecycle services. The company was formed in 2022 after CXV Global (Crest Solutions, Xyntek, and VistaLink) and Panacea Technologies joined forces. For over three decades, Catalyx's partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety. To learn more about the company's experience and comprehensive suite of capabilities and solutions, visit .

    Job Description

    This is a true QA oversight role within R&D

    Required Experience and Skills:

    ·Experience working in a Pharmaceutical/Biotechnology industry; experience working in a health authority regulated ( GxP) environment.

    · 5 - 8 years of industry experience including computer system validation, System Life Cycle (SLC), software validation, and/or Quality Assurance functions.

    ·High level of expertise and exposure with agency regulations, such as 21 CFR Part 11, Part 58, Part 210, Part 211 from the US Food and Drug Administration.

    ·High level of expertise in SLC methodology (, V-model, waterfall, agile, spiral) including change management.

    · Extensive experience providing oversight for adherence to enterprise SLC and procedures.

    ·Proficient skills dealing with and understanding typical laboratory facilities and equipment.

    ·Ability to prioritize and manage multiple initiatives, projects concurrently.

    ·Excellent interpersonal skills including ability to work as a team member in a collaborative environment.

    ·Excellent written and communication skills including thorough knowledge of Good Documentation Practices.

    ·Possess excellent time management skills.

    ·High attention to detail.

    Preferred Experience and Skills:

    ·Experience with calibration and qualification.

    ·Expertise with configuration management.

    ·Knowledge of published regulatory agency data integrity guidance.

    ·Moderate level of experience with electronic tools such as software providing document management and testing capabilities.

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