• Document Control Specialist

    Actalent (Santa Clara, CA)


    Job Title: Document Control SpecialistJob Description

     

    As a Document Control Specialist, you will maintain the document change control process via the engineering change control system, ensuring accuracy and conformance with format standards. You will be responsible for reviewing, processing, and releasing documents using various software packages, while ensuring the highest level of accuracy in revised documents and completed change orders.

    Responsibilities

    + Log, track, and process Document Change Orders (DCOs), maintaining material and Bill of Materials (BOM) data.

    + Review, process, and release documents with accuracy and format conformance using a variety of software packages.

    + Check revised documents and completed change orders to assure the highest level of accuracy and conformance with approved format and standards.

    + Maintain electronic files of master active or archived documents, including native source application files and .pdf viewable files.

    + Maintain controlled access to master files and archived documents on the system and shared servers.

    + Assist in the data entry setup of training sets for new hires, including technical and Quality Management System procedures when needed.

    + Assist in the data entry of employee training records when needed.

    + Assist in maintenance of Direct Labor Competency Assessment Records when needed.

    + Support audits by regulatory agencies by participating in the audit backroom, reviewing documents, retrieving records, and other duties associated with the audit.

    + Assist in the development and implementation of solutions to a variety of problems, including participation in any Corrective and Preventive Actions (CAPA) activities for Document Control and Training.

    + Manage the review and approval of Quality Management System (QMS) changes.

    + Perform other duties as assigned.

    Essential Skills

    + Document control

    + Quality assurance

    + Document management

    Additional Skills & Qualifications

    + Bachelor’s Degree with a minimum of 2 years of experience, or a high school diploma and 6+ years of experience in document control in a manufacturing environment.

    + Experience working in the medical device industry is preferred.

    + Practical knowledge of current Good Manufacturing Practice (cGMP) requirements.

    + Working knowledge of MS Word, Excel, and other database systems. Knowledge of Solid Works or other drawing programs preferred.

    + Ability to work in a fast-paced environment while managing multiple priorities.

    + Strong written and verbal communication skills, with the ability to effectively communicate with all levels of the organization.

    + Ability to operate as a team and/or independently while demonstrating flexibility to changing requirements.

    + Physical ability to lift objects up to 25 lbs.

     

    Work Environment

     

    The position is based in a quality lab environment, providing a professional setting conducive to meticulous document management tasks.

    Pay and Benefits

    The pay range for this position is $35.00 - $37.00/hr.

     

    Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

     

    • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

     

    Workplace Type

     

    This is a fully onsite position in Santa Clara,CA.

     

    Application Deadline

     

    This position is anticipated to close on May 27, 2025.

    About Actalent

    Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

     

    The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

     

    If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.