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    Validation Engineer - Jersey City, United States - Cynet Systems

    Cynet Systems
    Cynet Systems Jersey City, United States

    1 week ago

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    Description
    Job Description:

    Pay Range $50hr - $55hr
    • Support cross functional teams in processing documents (assist in document editing, review, approvals).
    • ssist in process improvements for Document Control Management/Training processes.
    • Revise SOPs related to Document Control/Training on an as needed basis.
    • Help to support the management and maintenance the electronic document management system ensuring Controlled Documents are processed in accordance with SOPs including creation, revision, approval, and obsoletion of Controlled Documents.
    • Help to support the management and maintenance of the training system ensuring new users are trained, accounts are set up appropriately, and the system remains in a state of compliance.
    • Maintain internal formatting standards and ensure all documentation are formatted accordingly.
    • Formatting may include creating templates, fonts and style, pagination and numbering and any other activities required to achieve document requirements. Contributes to continuous improvement of document templates.
    • Ensure Document Change Requests are created for document revisions and provide appropriate and applicable information on document revisions; creates Document Change Controls for applicable documents.
    • Management of the Document Control/Management and Training Program will require administrative duties such as Scanning, organizing, and maintaining documents; Assisting file migrations; Providing support during audits and inspections.
    • 3-5 years experience of Quality Assurance experience in the Pharmaceutical/Biotech Industry.
    • Experience in the use of validated computer systems for the management of regulated documents and training, including electronic records and electronic signatures.
    • Experience with Veeva Vault is required.
    • Experience with ComplianceWire is required.
    • Experience in maintaining cGMP compliance is preferred.
    • Excellent organizational skills and the ability to handle multiple priorities and projects.
    • Excellent communication skills with the ability to interact with all levels throughout the organization.
    • Strong written and verbal communication skills as well as attention to detail.
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