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    Quality Assurance Specialist - Seattle, United States - Aequor

    Aequor
    Aequor Seattle, United States

    4 weeks ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    QA Associate Specialist – Document Control –

    Seattle, WA 98109

    Duration: 12 months with possible extension

    Pay rate: $37.36/hr. on W2

    Job Description: Top Skills:

    2+ years of Document Control & Reporting Experience,

    Veeva experience preferred

    Technical troubleshooting

    Self-motivated, independent, great communication

    Experience working cross-functionally

    Position Summary:

    The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client Cell Therapy Above-site organization, including document approvals, document change control process, periodic review, and system reporting.

    Duties/Responsibilities:

    Primary responsibilities include:

    Managing an electronic document system for the Cell Therapy Above-Site which includes reviewing and approving document change requests, troubleshooting, and releasing documents to an effective state.

    May write and revise document control procedures including participating in the development and roll-out of document control tools.

    Follow Policies, SOPs, and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.

    Assist with cross-training of Document Control personnel and customers to ensure adherence to procedures.

    Execute the process and procedures for identifying, collecting, distributing, and filing the controlled documents for the site.

    Generate document management system reports for Quality Council metric reporting.

    Support internal and external audits and regulatory inspections if required. Assist with document retrieval /organization support during regulatory inspections.

    Provide communication as to the status of Quality Systems deliverables to customers, management, and stakeholders.

    Some technical writing skill set and being able to critically review documents while effectively inputting and expressing Quality principles

    Position Reports to – Associate Director, QA Training & Document Control

    Education: Bachelor's degree or equivalent

    Experience Basic Qualifications:

    Minimum of 1 year of relevant document control experience in a cGMP/FDA-regulated environment.

    Strong communication and customer service skills.

    Some technical writing skill sets include the ability to critically review documents while effectively inputting and expressing Quality principles.

    Strong computer skills with MS Office (e.g. Word, Adobe, Visio, and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)

    Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement.

    Able to prioritize, manage time well, multi-task, and troubleshoot effectively.

    Ability to work effectively and collaboratively at a fast pace with cross-functional departments to finalize time-sensitive deliverables.

    Possesses project management skills.

    Experience interacting with the FDA or other regulatory agencies is strongly preferred.

    Strong knowledge of cGMPs and domestic regulatory requirements.

    Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.).

    Must complete tasks independently, notify manager of decisions outside of established processes, and have the ability to build an internal network.

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