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Rahway

    CSV/QA Engineer - Rahway, United States - Catalyx

    Catalyx
    Catalyx Rahway, United States

    4 days ago

    Default job background
    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 (e.g. 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 (e.g., 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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