6 days old
2017-11-142017-12-12

Technical Writer

Andover, MA 01810
  • Job Code
    585411
  • Payrate
    $25 To $30

Technical Writer


Key Areas of Responsibility



  • Plan, develop, organize, write and edit documentation
  • Establish Document Control support to authors and process owners in defining and producing lean Quality System documents and records; ensure proper quality of the content of documentation and records
  • Establish and manage proper document review processes
  • Ensures availability/publishing of controlled documents
  • Establish, monitor and respond to metrics on the efficacy and efficiency of the document management system and its ability to support the business


Key Performance Indicators



  • Productivity
  • On time delivery of results
  • Non-conformities and nonconformity resolution rates


Job Overview



  • Ensures that all controlled Quality documents are maintained to the latest issue, and that these documents are made available at all locations where operations essential to the effective functioning of the Quality Management System are performed.
  • Ensures that all obsolete documents shall be withdrawn if retained for record purposes.
  • Controls & maintains the document management system for issuance recording / filing, tracking, retrieval of documents like procedures, plans, QA/QC records, Specifications and related documents.
  • Leads and supports authors of controlled documents to be lean, accessible, easy to maintain and according to the agreed look and feel.


Qualification



  • A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.



  • Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends.
  • Follows processes and operational policies in selecting methods and techniques for obtaining solutions.
  • Ability to interact and communicate in English, including demonstrable writing, speaking, and comprehension skills; ability to communicate across levels of the organization.
  • BA/BS degree and a minimum of 3 years of similar work experience.



  • Familiarity with Document Management System tools
  • Experience running effective process improvement projects
  • Knowledge of FDA regulations and regulatory requirements
  • Procedural or Technical writing experience.



  • Awareness of Project Management Institute standards


Transcription


Key Areas of Responsibility



  • Listen and document live discussion between inspector and interviewees including:


    • Personnel entering and leaving the room with time stamp
    • Conversations [questions and answers] with identified speaker
    • Requested documentation
    • Logistical updates [start/end of day, breaks, production floor tour, etc.] with time stamp



Key Performance Indicators



  • Accuracy
  • On time delivery of results


Qualification



  • A seasoned, experienced professional with a full understanding of area of specialization



  • Minimum of 3 years of similar work experience.



  • Knowledge of FDA regulations and regulatory requirements

Categories

  • Information Technology

Randstad utilizes a technology-driven focus with a human touch to provide better staffing and business solutions to organizations around the world. Our team of experts match professionals with available career opportunities in a variety of fields.

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Technical Writer

Randstad Technologies
Andover, MA 01810

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Technical Writer

Randstad Technologies
Andover, MA
US

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