Technical Writer Position Available In St. Louis City, Missouri
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Job Description
Job Title:
Technical Writer II Job Description We are seeking a dedicated Technical Writer II with a wealth of experience in technical/scientific writing. This role involves crafting and updating cGMP documentation essential for the production of life-saving clinical and commercial drug products. The successful candidate will collaborate with subject matter experts to ensure the delivery of high-quality documents that support Right-First-Time manufacturing. Responsibilities Craft and update cGMP documentation to support drug product manufacturing. Utilize standard batch record templates and collaborate with subject matter experts. Identify and correct gaps or misalignments between batch records and SOPs. Analyze manufacturing deviations to enhance reference documentation. Optimize the layout, organization, and content of technical documents. Essential Skills Proven experience in technical writing within a pharmaceutical environment. Bachelor’s Degree in a STEM field. Minimum of 2 years of experience in a GMP-regulated Biologics or Pharma Industry. Experience writing SOPs and pharmaceutical batch record or validation documents. Knowledge of Good Manufacturing Practices and US/EU regulations. Additional Skills & Qualifications Success in working with cross-functional teams and providing proactive communication. Organizational skills and the ability to work efficiently under pressure. Expertise in oral and written communication in English. Proficiency in Microsoft Office applications. Experience in pharmaceutical operations is advantageous. Work Environment The position is within a fast-paced contract manufacturing environment where the ability to manage multiple tasks simultaneously is essential. The role does not involve research and development activities.