Documentation Specialist II

Location: Los Gatos, CA, United States
Date Posted: 05-16-2018
Position Role/Tile:  Documentation Specialist II 
Location: Los Gatos, CA.


This position is responsible for performing daily activities related to the document and record managementprocess, document support for development,and training system.Provides superb customer support while ensuring compliance to regulatory requirements and internal policies and procedures.

Secures and controlslegacy development files and obsolete files to maintain traceability and prevent misuse. Ensuresobsolete revisions are removed from points of use.

Provides guidance to document initiators in document formatting according to approved procedures, templates and standards, such as routing, tracking of document status, approval notification, version control.Formats documents according to templates.Ensures complete Change Requests, monitor approval.

Collaborates with supervisors to assign training requirements for new employees.Enters group training records in training system.Runs proactive training gap reports.

Supports Development in creation, maintenance and design transfer of BOMs, part specifications, and manufacturing drawings and instructions to Production.

Ensures quality records and reports are reviewed, organized,scanned and filed. Retains and manages records according to company record retention requirements.

Supports internal and external audits.Provides documents and data records in a timely fashion.Participates in audit preparation, meetings, and responds to questions related to job function. Manages requests in audit ready room.

Maintains office supplies for Quality department.

Experience Required:
  • AA or Bachelor's Degree, or high school degree with equivalent experience.
  • 3-5 years related experience in quality records management in a cGMP environment.
  • Excellent organization and attention to detail.
  • Excellent verbal and written communication including spelling, grammar and editing skills.
  • Strong interpersonal skills, ability to work independently and in teams.
  • Microsoft Word expertise with a solid understanding of the review and formatting tools required.
  • Visio, Excel, and PowerPoint competencies.
  • EDMS electronic document management system and/or LIMS experience.

Experience Preferred:
  • AA or Bachelor's degree.
  • Experience with US FDA regulations for medical devices, plus international ISO 13485:2016.
  • Experience with IVD products, following applicable guidelines.
  • SAP, TrackWise experience.

Expectations to successfully complete within 30 days:
  • General training (new employee, safety and quality system)
  • Demonstrated proficiency with:
    • Documentation templates
    • Master document indexes, record logs
    • Training system application
  • Demonstration of the following skill sets:
    • Ability to follow direction and procedures
    • Work independently with little oversight
    • Self-starter
    • Ability to manage workload
    • Demonstrate a service-oriented mindset
    • Resourcefulness
    • Strong organizational skills and attention to detail
    • Strong written and verbal communication skills and interpersonal skills
  • Document control point of contact for the company:
    • Provide guidance to employees on completing Change Request package
    • Identify training requirements for changed documents
  • Maintain quality documents and records.
    • Retention and management of company quality documents and records according to company record retention requirements
    • Maintain filing in an organized and timely manner
  • Maintain training matrix:
    • Oversee and training requirements, update matrix with supervisors
  • Ability to support internal and external audits:
    • Provide documents and data records in a timely fashionParticipate in audit preparation, meetings, and respond to questions related to job function
  • Maintain office supplies for Quality group
  • Familiar with document change management and control process at RMS
  • Familiar with training process at RMS

Central Business Solutions, Inc,
37600 Central Ct.
Suite #214
Newark, CA 94560.
Central Business Solutions, Inc(A Certified Minority Owned Organization)
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Central Business Solutions, Inc
37600 Central Court Suite 214 Newark CA, 94560
Phone: (510)-713-9900, 510-573-5500 Fax: (510)-740-3677
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