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Associate Technical Writing

4 months ago

Thousand Oaks, United States Ronin Staffing, LLC Full time
Job DescriptionJob Description

HERE’S THE JOB DESCRIPTION:
Title: Associate Technical Writing #12791
Pay Rate: up to $32/hr
Location: Remote-Based
Length: 2 year contract + possible extension

Top Must Have Skills:

  • GMP experience
  • Sound knowledge of Quality Assurance principles, Good
  • Manufacturing Practice and Good Distribution Practice.
  • Experience in Technical writing, regulated environment experience ( Food industry is acceptable); document version control experience.
  • Works autonomously, respecting deadlines
  • Works with a high degree of discipline and attention to detail


Job Details:

  • Owns and Manages Change Control Records.
  • Owns and Manages Deviations, and Lead Root Cause Analysis.
  • Develops, writes, edits, and formats materials such as Standard Operating Procedures, Business Practices, forms, checklists, technical manuals, installation guides, user manuals, and related technical and business process documentation.
  • When creating, updating and enhancing the documentation, adhere to format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality.
  • Maintain data accuracy and perform data analysis for Management reviews of the quality system on a periodic basis.
  • Additionally, this position will be required to administer the processing of documents via the established Document Processing Review process.
  • May require communication through a variety of media (e.g., CD, intranet, on-line training, etc.)
  • Incidental travel might be required.


Responsibilities:

  • Own and manage change control records
  • Own and manage minor and major deviation records and lead root cause analysis sessions
  • Own and manage CAPA and CAPA EV records, ensuring that they are implemented as intended.
  • Maintain data accuracy and perform data analysis for Management reviews of the quality system on a periodic basis.
  • Authority - Apply risk-based approach, making decisions and escalating issues appropriately
  • Outputs - Contribute continuously improving the level of GDP compliance in Global Distribution Supply Chain.

 

Qualifications:

  • Bachelor’s degree or equivalent in Life Sciences + 2 years’ experience in GMP / GDP compliance.  In the absence of a Life Sciences degree, 4+ years’ experience in GMP / GDP compliance
  • Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice.
  • Fluency in English , Dutch-preferable
  • Strong word processing, database and spreadsheet application skills and experience in Quality Management Software systems (e.g. TrackWise, EDMQ, etc)
  • MS Office expertise


Preferred Qualifications:

  • Experience in audit / inspection support
  • Previous technical writing experience
  • Document version control experience


Competencies:

  • Effective communication skills at multiple levels, areas and countries
  • Ability to apply risk-based approach, making decisions and escalating issues appropriately
  • Analytical and evidence-based approach to problems.
  • Ability to see the connection between issues, to identify common factors and bring the correct stakeholders together.
  • Pro-active in proposing solutions and driving tasks to completion
  • Works autonomously, respecting deadlines
  • Works with a high degree of discipline and attention to detail