Job Description
Job Description
POSITION SUMMARY:
Reporting to the Executive Director of Manufacturing & Supply Chain, the Technical Writer is responsible for creating, editing, and maintaining high-quality technical documents that adhere to GMP regulations. This includes Standard Operating Procedures (SOPs), batch records, validation protocols, deviations, change controls and training materials.
PRINCIPAL DUTIES:
- Author, format, and update various technical documents, including Standard Operating Procedures (SOPs), Batch Records, Work Instructions, and assist with Engineering Protocols (e.g., Installation Qualifications, Operational Qualifications).
- Perform thorough investigations of manufacturing, supply chain, visual inspection and packaging non-conforming events that could include review of cGMP documents and historical review of the quality management system.
- Perform investigations using structured root cause analysis tools (fishbone, 5 Why’s, etc.) and partner with team members across operations (manufacturing, supply chain, quality, engineering) to determine “true” root cause.
- Conduct personnel interviews of those individuals involved with events.
- Ensure all written materials align with company, quality, and FDA guidelines across all manufacturing components.
- Collaborate with Subject Matter Experts (SMEs) and cross functional teams to gather and verify technical information, ensuring the accuracy and completeness of documentation.
- Review and edit existing documentation for clarity, accuracy, and compliance with industry regulations.
- Assist in the development of training materials and conduct training sessions for staff on documentation practices.
- Ensure all documentation is properly version-controlled and archived according to regulatory requirements.
- Participate in audits and inspections, providing documentation as needed to demonstrate compliance.
- Stay up to date with industry regulations and guidelines (e.g., FDA, EMA) to ensure that all documentation meets regulatory requirements and contributes to regulatory submissions.
- Additional responsibilities as needed
QUALIFICATIONS AND EXPERIENCE:
- 4+ years of Experience
- Bachelor’s degree in communications, professional writing, English, biological/ medical/ engineering sciences, or equivalent preferred