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Sr. Technical Writing Specialist
Ref No.: 18-04167
Location: Santa Ana, California
Position Type:Contract
Start Date / End Date: 09/25/2018 to 12/29/2018
 
Title:  Sr Specialist, Technical Writing
 
 
 
Role Purpose:
Develop and create accurate CMS/DITA specialized technical documents.
 
Job Functions:  
Essential Job Functions % of time
  1. Provide technical writing expertise to create complex design control documentation packages including process validation documents (e.g, Installation Qualification, Operations Qualification, Process Qualification)  CMS/DITA specialized protocols and reports, technical summaries, and test procedures
55
  1. Maintain documentation in a standard format following established guidelines
5
  1. Review documents for style, clarity, grammar, and punctuation
5
  1. Identify and correct inconsistencies of thought, development, or organization and confer with authors to recommend an appropriate adjustment in documents and procedures
5
  1. Collaborate with stakeholders (e.g, production employees, technicians, engineers, project teams, regulatory teams and management) to develop an understanding of the product, component, or device changes
15
  1. Recommend improvements to current documentation practices and propose recommended changes
5
  1. May lead special projects (e.g implementation of new style of documentation procedures)
5
Marginal Job Functions  
  1. Other duties assigned by Leadership; Provide guidance and training to lower level employees
5
  100%
Required Education/Skills/Experience: 
  • Bachelor's degree in related field required
  • 5 years of technical writing experience required
  • Experience with CMS/DITA documentation processes HIGHLY preferred.
  • Experience in the biotechnology industry (e.g., Quality Assurance, Regulatory) preferred
  • Proven expertise in Microsoft Office Suite including Word, Excel, PowerPoint, and Publisher; Adobe and Photoshop preferred
  • Excellent editing and proofreading skills
  • Excellent written and verbal communication skills in English including negotiating and relationship management skills
  • Excellent problem-solving and critical thinking skills
  • Full knowledge and understanding of policies, procedures and guidelines relevant in the development of technical documentation
  • Full knowledge of documentation (e.g, procedures, routers, process sheets, technical summaries, protocols, and test reports)
  • Excellent technical writing skills
  • Full knowledge of product assembly procedures
  • Ability to manage competing priorities in a fast paced environment
  • Strict attention to detail
  • Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on projects
  • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations