Technical Documentation Specialist Job at Insight Global, Miami, FL

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  • Insight Global
  • Miami, FL

Job Description

Must-Haves

  • 2–5 years of experience in documentation management within the pharmaceutical or nutraceutical industry
  • Strong knowledge of GMP, GDP, FDA regulations, and ISO standards
  • Proficiency with documentation systems and software (e.g., Microsoft Office, document control platforms)
  • Bachelor’s degree in pharmaceutical sciences, engineering, or life sciences

Plusses

  • Familiarity with Softgel manufacturing processes
  • Experience with electronic documentation systems
  • Exposure to regulatory frameworks beyond FDA (e.g., EMA, global standards)
  • Prior involvement in audits or regulatory inspections
  • Experience supporting product development or technology transfer projects

Role Overview

This role is responsible for creating, revising, and managing technical documentation within a pharmaceutical or nutraceutical manufacturing setting, with a specific emphasis on Softgel production. The position supports cross-functional teams including production, quality assurance, customer service, purchasing, and R&D, ensuring compliance with regulatory standards and operational excellence.

Day-to-Day Responsibilities

  • Create, review, revise, and maintain SOPs, specifications, batch records, master formulas, protocols, and reports
  • Implement document control systems aligned with Good Documentation Practices (GDP)
  • Maintain accurate records of manufacturing processes in compliance with FDA, GMP, and other standards
  • Prepare technical documents for product development, validation, and technology transfer
  • Collaborate with production and quality teams to resolve documentation discrepancies
  • Document deviations, investigations, and CAPAs accurately
  • Provide documentation for internal and external audits
  • Ensure all documents meet regulatory compliance standards (FDA, EMA, etc.)
  • Update documents in response to regulatory changes or process improvements
  • Act as a liaison between manufacturing, R&D, quality, and regulatory teams
  • Train staff on documentation standards and GDP
  • Participate in change control processes and ensure timely updates
  • Identify and implement improvements to documentation processes
  • Manage electronic documentation systems when applicable
  • Monitor industry trends and ensure ongoing compliance

Job Tags

Work at office,

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