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 processesExperience with electronic documentation systemsExposure to regulatory frameworks beyond FDA (e.g., EMA, global standards)Prior involvement in audits or regulatory inspectionsExperience supporting product development or technology transfer projectsRole 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 reportsImplement document control systems aligned with Good Documentation Practices (GDP)Maintain accurate records of manufacturing processes in compliance with FDA, GMP, and other standardsPrepare technical documents for product development, validation, and technology transferCollaborate with production and quality teams to resolve documentation discrepanciesDocument deviations, investigations, and CAPAs accuratelyProvide documentation for internal and external auditsEnsure all documents meet regulatory compliance standards (FDA, EMA, etc.)Update documents in response to regulatory changes or process improvementsAct as a liaison between manufacturing, R&D, quality, and regulatory teamsTrain staff on documentation standards and GDPParticipate in change control processes and ensure timely updatesIdentify and implement improvements to documentation processesManage electronic documentation systems when applicableMonitor industry trends and ensure ongoing compliance