Insight Global
This range is provided by Insight Global. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $50,000.00/yr - $52,000.00/yr
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
Seniority Level Associate
Employment Type Full-time
Job Function Writing/Editing
Industries Pharmaceutical Manufacturing
Benefits
Medical insurance
Vision insurance
401(k)
Location Miami, FL
#J-18808-Ljbffr
Base pay range $50,000.00/yr - $52,000.00/yr
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
Seniority Level Associate
Employment Type Full-time
Job Function Writing/Editing
Industries Pharmaceutical Manufacturing
Benefits
Medical insurance
Vision insurance
401(k)
Location Miami, FL
#J-18808-Ljbffr