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Document Controller I
Ref No.: 20-04189
Category: Experienced Professional
Location: Palo Alto, California
Position Type:Contract
Start Date / End Date: 07/27/2020 to 01/26/2021
Genesis10 is currently seeking a Document Controller I with our company client in their Palo Alto, CA location. This is a 6 month + contract position.


Description:
  • Seeking a Document Controller
  • As a Document Administrator you will be a part of the QRS (Quality, Regulatory and Safety) organization and specifically report into the QRS Operations team
  • Your role provides support to all groups to ensure that documentation is reviewed, approved, released and managed appropriately including compliance with a variety of regulatory requirements
  • The Document Administrator performs tasks such as reviewing documents and change requests to be routed for review and approval, ensuring the appropriate approvers, managing the effectiveness and efficiency of the process, and providing metrics to Management Review for process monitoring


Responsibilities:
  • Serve as a primary point of contact for control of health documentation including Manuals, Policies, Procedures, Work Instructions, Training Materials, Records, Forms and Templates
  • Ensure compliance of document control processes with SOPs and Work Instructions
  • Provide administrative oversight to the document control processes so document owners can appropriately and efficiently use document management tools including; review of change orders prior to routing, sending notifications to approvers to ensure timely document review, prepare and release final versions of documents, and review and upload records
  • Provide training to new employees on the Document Control processes and associated tools
  • Provide technical process / tool support where requests to employees regarding document control and management
  • Support regulatory, 3rd party and internal audits by gathering documents, records and change orders including electronic audit trails
  • Help establish and maintain metrics regarding the compliance and effectiveness of the Document Control process
  • Maintain SOPs, Work Instructions and Forms associated with the Document Control process to ensure they represent current practices
  • Participate in validation of electronic Document Control tools
Requirements:
  • 3+ years of experience in electronic Document Administration in a Medical Device, Pharmaceutical or Biotech company
  • Experience with common document creation / editing tools such as Word, Excel, Acrobat, Powerpoint, Google Docs, Sheets, and Slides
  • 2+ years of experience with using and managing electronic document management tools that incorporate automated workflows. Examples include: AODocs, EtQ, Pilgrim, Windchill, Trackwise
  • Excellent interpersonal skills working across multiple divisions and sites and external resources
  • Strong customer service orientation and corresponding skills
  • Excellent written and verbal communication skills
  • Able to work as a W2 employee of Genesis10 (no Corp-to-Corp)
  • Desired:
    • Bachelor's Degree
    • 5+ years of experience in electronic Document Administration in a Medical Device, Pharmaceutical or Biotech company
    • 2+ years of additional general Quality Assurance experience in Medical Devices

If you have the described qualifications and are interested in this exciting opportunity, please apply!
About Genesis10:-
Genesis10 is a leading U.S. business and technology consulting firm with hundreds of clients needing proven talent and solutions to power their strategic initiatives. If you are a high performing business or IT professional with solid, referenced experience, we want to meet you. Genesis10 recruiters and delivery professionals are highly accomplished career advocates, who get to know you beyond your resume to position you with the opportunities that fit your skills, experience and aspirations. We have benefit options to fit your needs and a support staff that works with you from placement throughout your engagement project after project. To learn more about Genesis10 and to view all our available career opportunities, please visit us at www.genesis10.com. "Genesis10 is an Equal Opportunity Employer, M/F/D/V