Insight Global
Must-Haves
25 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)
Bachelors 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
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