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Associate Technical Writing

Thousand Oaks, CA

“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to this company, its operations, or its staff.”

Top 3 Must Have Skill Sets:        
  • 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
Day to Day Responsibilities:        
Managing Change control records, deviations and CAA records. Creating and maintaining metrics and management reviews of quality system on a periodic bases. Providing support in creating and maintaining Standard Operating Procedures (SOP), Business Practices etc. Contribute continuously improving the level of GDP compliance in Global Distribution Supply Chain

Summary
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.); Skills: ; MS Office expertise; previous technical writing experience; regulated environment experience; document version control experience; excellent communication/writing skills
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.
Incidental travel might be required.

Authority
Ability to apply risk-based approach, making decisions and escalating issues appropriately

Outputs
Contribute continuously improving the level of GDP compliance in Global Distribution Supply Chain.

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

Qualifications
Minimum Requirements
  • 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)
  • Preferred Requirements
  • Experience in audit / inspection support
  • Technical writing skills

"This posting is for Contingent Worker, not an FTE"
 

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