<p>The Position</p> <p>The Stability Coordinator will assist in coordinating stability studies, drafting study documentation, preparing stability samples for study initiation, tracking pull dates, and maintain stability data and reports. The Stability Coordinator will identify and retrieve samples as required per stability schedules and assist with shipping and receiving of stability samples as needed.</p> <p>The ideal candidate will have experience evaluating and maintaining stability data. The Stability Coordinator will maintain folder creation, document filing, and study reports. The Stability Coordinator is also responsible for the reconciliation and disposition of stability samples upon completion of studies.</p> <p>Responsibilities</p> <ul> <li>Authoring, review, and revision of Stability documents including protocols, work instructions, and Stability reports. </li><li>Assist in the set down and management of internal and external retains and reserve samples. </li><li>Stability study initiation, coordination, tracking, and sample management, including sample storage in stability chambers and distribution of samples to testing lab(s). </li><li>Assist in the setup and tracking of monthly stability timepoint pulls. </li><li>Assist in routine maintenance of stability chambers. </li><li>Assist in the management of stability program data and reports, maintain program study folders, and compile and interpret data. </li><li>Help Ensure that the stability testing results reported are valid, accurate, and documented per applicable regulatory requirements. </li><li>Other duties, as needed. </li></ul> <p>Requirements:</p> <ul> <li>Bachelor's degree in Chemistry (or related scientific field) with 1-2 years' relevant experience (pharmaceutical CMO/CRO). </li><li>Experience with Excel, PowerPoint, and Word skills. </li><li>Strong verbal and written communication skills and ability to work with diverse professionals in a matrix environment. </li><li>Solid organizational skills with ability to adapt to changing priorities and deadlines. </li></ul> <p>Preferred:</p> <ul> <li>Knowledge of cGMP and cGLP guidelines for contract manufacturing and analytical laboratories and ICH/FDA guidance documents. </li><li>Experience with stability programs and sample handling. </li><li>LIMS system experience. </li><li>Experience with Smartsheet, or similar. </li></ul>