The Technical Writer will develop technical materials, such as SOPs, analytical protocols, reports, or operating and maintenance instructions and formal investigations.
* Maintain records and files of work and revisions. * Prepare and write analytical protocols, reports, and technical documents. * Prepare specifications, test methods and test reports for raw materials and drug products. * Edit, standardize, or make changes to material prepared by other writers or establishment personnel. * Confer with customer representatives, vendors, plant executives to establish technical documents and to determine subject material to be developed for product filing. * Review published materials and recommend revisions or changes in scope, format and content. * Observe production, developmental, and experimental activities to determine operating procedure and detail. * Work with internal teams to obtain an in-depth understanding of the product and the documentation requirements
* Scientific background, preferably in Chemistry. Proven working experience in technical writing of analytical documentation * Excellent written skills in English. * Strong working knowledge of Microsoft Office. * Communication, Written - Ability to communicate in writing clearly and concisely. * Sound technical writing skills, verification skills and a strong understanding of scientific concepts. * Contribute to the preparation of regulatory filing documents and other technical documents through authoring and verification of the documents. * Strong documentation skills, strong GMP, GLP. * Must be able to move about the facility * Must be able to remain sedentary for periods of time
Education: Bachelor's Degree (four year college or university)