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)
Experience: Two to four years related experience
Associated topics: administrative, administrative and operational assist, administrative support, assist, assistant, associate, intern, office assistant, operational support, operator