Analytical Development Technical Writer

  • Charles City
  • Cambrex
<br /><b>Cambrex</b><br /><br /><br /><b>Analytical Development Technical Writer</b><br /><br />US-IA-Charles City<br /><br /><b>Job ID:</b> 2024-3771<br /><b>Type:</b> Regular Full-Time<br /><b># of Openings:</b> 1<br /><b>Category:</b> Analytical Development<br />Cambrex - Charles City<br /><br /><b>Overview</b><br /><br /><p><span><span><span>The AD Technical Writer will </span><span>be responsible for</span><span> consistently generating high quality technical documents, such as test procedures, protocols, and reports based on data collected by other members of the Analytical Development department that meet the needs of other departments, clients, and regulators. Compliance with SOPs, cGMP, ICH, and other regulatory guidelines is </span><span>required</span><span> to perform most job tasks.</span></span><span> </span></span></p><br /><br /><b>Responsibilities</b><br /><br /><p><span><span>Drafting and revising controlled documents such as test procedures, method evaluation protocols, reports, and SOPs while following established guidelines for correctness, completeness, clarity, and format.</span></span><span> </span></p><ul><li><span><span>Coordinate the approvals of these documents through the use of software such as </span><span>MasterControl</span><span> and </span><span>TrackWise</span><span>.</span></span><span> </span></li><li><span><span>Compile and present data from multiple sources such as laboratory notebooks and various laboratory instrumentation software.</span></span><span> </span></li><li><span><span>Maintain open communication with members of AD, QC, and QA to ensure </span><span>timely</span><span> delivery of </span><span>high quality</span><span> documents to support evolving business needs.</span></span><span> </span></li><li><span><span>Continuously improve documentation systems to increase efficiency and compliance with cGMP and/or other regulatory requirements.</span></span><span> </span></li></ul><br /><br /><b>Qualifications</b><br /><br /><p><span><span>Bachelor’s degree in Chemistry</span><span> or closely related field </span><span>required</span><span>.</span></span><span> </span></p><p> </p><ul><li><span><span>Minimum of 2 or more years of experience in a cGMP regulated laboratory environment highly preferred.</span></span><span> </span></li></ul><br /><br /><br /><img src="https://www.click2apply.net/v/rJzbyMu7EnpQrTZwVIrWZM" /><br /><br /><p>PI242186835</p>