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    Document Control Specialist - Ventura, United States - Quest Staffing Services, Inc.

    Quest Staffing Services, Inc.
    Quest Staffing Services, Inc. Ventura, United States

    3 weeks ago

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    Description

    Job Description

    Job Description

    Primary Function

    Coordinates, implements, and maintain Document Control and Training System (eQMS). Follows established procedures and policies to meet the demands of document control in a regulated medical device company

    Duties/Responsibilities


    • Responsible for coordinating engineering change notifications (ECNs), facilitating review, approval, and retention of documentation in accordance with established procedures.


    • Coordinates and supports change control activities for labeling, specifications, artwork, manufacturing procedures, etc.


    • Assigns unique identification numbers to documents, parts, and components in accordance with established procedures.


    • Maintains laboratory notebooks and associated log sheets.


    • Coordinates record retention processes, ensuring compliance with company policies and regulatory requirements.


    • Supports Quality System training and maintains training records and training effectiveness documentation and records.


    • Performs self-checks/self-audits on document control and training activities and documentation at scheduled intervals.


    • Serves as global administrator of electronic Quality Management System, QT9.


    • Supports user requests for documentation.
    • Identifies and implements opportunities for process enhancements and efficiency improvements within the document control/Training function.


    • Other duties as assigned.

    Special Knowledge


    • Experience in document control, ideally in regulated industries like manufacturing, pharmaceuticals, or medical devices.


    • Proficient in communication and working with teams that consist of diverse personnel and scattered locations.


    • Advanced English skills: writing, grammar, proofreading, redlining.


    • Technical proficiency and competence in document control software and other relevant technologies, such as electronic document management systems, Microsoft Office Suite, and data entry/typing

    Skills


    • Exceptional organizational skills and attention to detail, with the ability to manage multiple tasks concurrently.


    • Strong aptitude for learning, with a growth mindset and eagerness to acquire new skills.


    • Understanding of best practices for record retention, storage, and archiving, along with compliance requirements.

    Education/Training


    • Prefer Bachelor of Science or equivalent with at least 2 years' experience in documentation control systems, 5-7 years without a degree with preference in coordination and administration of systems within FDA QSR/ISO regulated industry.

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