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    QA Document Control Specialist - Bothell, United States - Primary Talent Partners, Inc.

    Primary Talent Partners, Inc.
    Primary Talent Partners, Inc. Bothell, United States

    3 weeks ago

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    Description
    6 days ago

    Be among the first 25 applicants

    Primary Talent Partners has a 6-month contract opening for a QA Document Control Specialist to join a global biopharmaceutical client of ours in Bothell, WA.


    Shift:
    Sunday - Thursday 10:00pm - 6:30am

    Note:
    No C2C or sponsorship is provided

    Pay:
    $52 - $56.50 per hour depending on experience

    Job Description

    Job Title:
    Quality Assurance Document Control (QADC) Associate Specialist


    Location:
    Bothell, WA*Onsite


    Shift:
    Sunday - Thursday 10:00pm - 6:30am

    Top Skills

    Strong communication and customer service skills.
    Innovation
    Able to prioritize, manage time well, multi-task, and troubleshoot effectively
    Smartsheet and Excel experience
    Ability to provide examples on how they have honed in on attention to detail
    Review of SOPs, procedures, edits and annotations within EDMS experience

    Knowledge, Skills, And Abilities


    Education:
    Bachelor's degree or equivalent

    Minimum of 1 year of relevant document control management experience in a cGMP/FDA regulated environment
    Strong communication and customer service skills.
    Some technical writing skill set and be able 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
    Possess project management skills.
    Experience interacting with FDA or other regulatory agencies 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 the ability to build an internal network
    Some labeling experience strongly preferred


    The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client Jump site, including the document change control process, issuance and reconciliation of batch records, batch related forms, product labels, and management of archival and retention of GMP records.

    Primary Responsibilities Include

    Issuing production batch records, labels, and other controlled documents to support manufacturing operations

    Responsible for the organization of cGXP controlled document files within the Document Center and ensure that records are readily retrievable and sent off to final archive facility as needed.

    Assist with managing the Document Center Archive room
    Managing an electronic document system for the JuMP site which includes reviewing and approving document change requests, troubleshooting and 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 with procedures
    Execute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the site
    Support internal and external audits and regulatory inspections. This may require data gathering, interviewing or escorting auditors during the audit. Assist with document retrieval /organization support during regulatory inspections
    Perform Document Control metric reporting and analysis for the local site data. This may require the use of relational databases and reporting tools to collate and analyze quality data
    Provide communication as to the status of Quality Systems deliverables to customers, management and stakeholders


    Working Conditions:


    Employees holding this position will be required to perform job-related duties supporting the Manufacturing Operations, related to batch documentation to support the various Manufacturing shifts.

    Weekend and off-shift support may be required.

    Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace.

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

    If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at

    #PTPJobs

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