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Associate Document Control Specialist

Associate Document Control Specialist

inSync StaffingHillsboro, OR, United States
23 hours ago
Job type
  • Full-time
Job description

Associate Document Control Specialist

Pay Rate / Range : / hr

Hours : 8 : 00 a.m. to 5 : 00 p.m.

Location : Hillsboro, OR

Duration : 1 year

Responsibilities :

  • Administer and manage Facilities Engineering records for the Hillsboro, Oregon site, ensuring efficient and compliant documentation practices.
  • Prepare, organize, and maintain documentation according to
  • quality policies and regulatory standards.
  • Support departments by developing, coordinating, and implementing equipment and system documentation.
  • Identify opportunities for process improvements and recommend enhancements to existing workflows.
  • Collaborate closely with Facilities Engineering and various Quality teams to ensure documentation accuracy and compliance.
  • Maintain consistent and effective communication with management, co-workers, customers, and counterpart teams at other sites.
  • Perform all duties within an FDA-regulated, cGMP-compliant environment.
  • Take ownership of responsibilities and drive process improvements locally and across the
  • Roche network.
  • Manage Turn-Over Packages (TOPs) and Commissioning Packages for HTO site projects.

Qualifications / Requirements :

  • Proficient in Enterprise Content Management (ECM) systems for archiving, managing, and accessing corporate engineering documents, drawings, TOPs, and commissioning files.
  • Skilled in FileMaker Pro and experienced with EDMS platforms such as QualityDocs for document and change management.
  • Advanced knowledge of ECM and EDMS systems to support responsibilities as Business Process Manager for HTO.
  • Ability to develop, document, and improve workflow practices and routine task processes.
  • Provide documentation support for investigations, discrepancies, and corrective actions.
  • Capable of reading, interpreting, and producing Facilities Engineering documentation.
  • Strong understanding of cGMP compliance requirements.
  • Exceptional documentation skills to maintain superior-quality project and system files.
  • Effective technical writing ability, including preparation and revision of technical reports, procedures, and other engineering documentation.
  • Proficient in Microsoft Word and general office applications.
  • Able to work independently with minimal supervision; flexibility to work overtime or adjust shifts as needed.
  • Ability to lift up to 50 pounds.

    • Training Duties :

  • Complete all required cGMP and Safety training per department policy.
  • Perform on-the-job training following established procedures.

    • Education / Training :

  • High school diploma or GED required; 1-3 years of relevant experience or an equivalent combination of education and experience.
  • Proficient with relational databases (e.g., MS Access, Oracle) and project management tools (e.g., TouchPoint, Condor, Trackwise, MS Project).
  • Familiarity with reporting tools (e.g., MS Access, Excel) and basic knowledge of SAP or similar CMMS programs.
  • Strong analytical, organizational, and problem-solving skills with high attention to detail and accuracy.
  • Excellent customer service skills; friendly, outgoing, and supportive communication style.
  • Strong interpersonal, verbal, and written communication skills.
  • Advanced proficiency in Windows environments.

    • Benefits :

  • Health insurance
  • Health savings account
  • Dental insurance
  • Vision insurance
  • Flexible spending accounts
  • Life insurance
  • Retirement plan

    • All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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    Document Control Specialist • Hillsboro, OR, United States