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Job Description

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

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

• 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 · 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