Documentation Specialist

3 weeks ago


Santa Monica, United States TekWissen ® Full time

Position: Documentation Specialist

Location: Santa Monica, CA 90404

Duration: 6 Months

Job Type: Contract

Work Type: Hybrid

Pay Rate: $35-$35/hr


Overview

TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.


Description

  • Ensures the correct and timely implementation of Change Requests (CR), Document Change Orders (DCOs) and Documents.
  • Maintains documentation manuals to ensure accuracy and current information.
  • Ensures the correct and timely input of database entries, verifies own work.
  • Supports the distribution and maintenance of GXP documentation.
  • Scans, verifies and archives documentation as needed Recommends process improvements and proposes changes.
  • Provides support with internal and regulatory audits/inspections as required. Provides user training for electronic systems (as applicable).
  • Creates and maintains document templates.
  • Assists with the periodic review process.
  • Supports the maintenance of monthly document control metrics.
  • Performs general word processing tasks and support.
  • Checks format and conformance to document templates, verifies own work.
  • Provides additional support and assistance on tasks and projects as directed by management.
  • Participates as required in training on issues affecting own area of work.
  • Notifies manager of compliance questions and issues.


TekWissen® is an equal opportunity employer supporting workplace diversity.


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