Technical Writer

Job description

A brief overview The Technical Writer I will prepare cGMP documentation, including protocols, reports, studies, Failure Mode and Effect Analyses (FMEAs), memos, forms, specifications, qualifications, change controls, deviations, Corrective and Preventative Actions (CAPA), Standard Operating Procedures (SOPs), and Master Batch Production Records (MBPRs). What you will do: - Write and revise documentation, such as protocols, reports, SOPs and associated forms, and MBPRs. Review and complete all documentation following cGMP guidelines - Ensure collaboration between all applicable departments, such as Production, Facilities, Materials Management, QA and QC - Adhere to manufacturing schedules and timelines - Participate in the validation of products and processes - Participate in project meetings with subject material experts Qualifications: - Bachelor's Degree BS Degree in Chemistry or related field - Minimum of 1 year of work experience as a chemist or scientist in a cGMP environment - 1 year of technical writing experience - Experience with peptide manufacturing and associated analytical methods - Experience with cGMP manufacturing and documentation standards (Preferred) - Understand...