Technical Writer

7 days ago


Edison, New Jersey, United States Paragon Staffing, LLC Full time
Job Description

Company Overview: Paragon Staffing, LLC specializes in matching skilled professionals with reputable companies. As a Documentation Specialist, you will play a crucial role in maintaining accurate records and ensuring compliance with regulatory requirements.

Responsibilities:

  • Create and revise documents used by production and quality departments.
  • Capture pictures of the production process to incorporate into documentation.
  • Enter data and information into the ER system, appropriate forms, and templates.
  • Initiate and carry out document change requests.
  • Interact with departments when questions arise.
  • Assist with document control activities.
  • Follow all DEA regulations per laboratory SOP.
  • Prepare, maintain, and revise analytical methods and specifications as required.
  • Track and assist with implementation of changes.
  • Process change control requests as required.
  • Validate and maintain calculations in controlled Excel spreadsheets and Empower.
  • Research and gather information in a timely manner.
  • Prepare, label, organize, and maintain files.
  • Comply with FDA guidelines/Company Policies of Data Integrity.
  • Other duties as assigned.

Requirements and Qualifications:

  • Must have 2+ years of experience in Documentation.
  • Computer experience a must. Excellent skills in Word, Excel, and Outlook.
  • Excellent attention to detail.
  • Dependable, positive attitude, and work ethic in a team environment.
  • Satisfactory written/verbal communication, English required.
  • Must have experience in packaging/manufacturing settings.
  • Experience in pharmaceutical/lab environments.
  • Quality control experience.

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