TECHNICAL WRITER, OPERATIONS

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

Full-time