A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit Position Summary & Responsibilities The Specialist, Training & Development creates and maintains training documents in the learning management system (LMS) for use across the site. This position conducts appropriate activities to ensure database integrity and regulatory compliance. This includes interfacing with leaders across the site and all operations to provide ongoing customer support, and consultation and provide data in support of internal audits and regulatory agency (FDA, MHRA, Safety, Environment, etc.) questions involving the training documentation; and assisting in the maintenance of a tracking and filing system that meets regulatory requirements. This position is also a link to the site learning community; including identification of trends, improvement opportunities, and continuous education on systems. Job Responsibilities Assists in the content development and management of the role framework and role assignments in the LMS, based on structure determined by Learning Management and Change Management process owners and area leaders. Develops content, role builds, role maintenance and courses by working collaboratively with leaders, facilitators and functional teams to ensure that the required information is provided for complete and accurate information in the learning management system. Interface with Learning resources to ensure the successful transfer of information from interfaced systems (Workday, Veeva, and others as required). Assists in response to audits of LMS to monitor consistency and accuracy of roles, entries, re-certifications, and compliance against site goals, as well as address and escalate inconsistency - including assisting with LMS validation change controls and upgrade activities. Furnishes data in support of internal and regulatory agency audits. This includes providing effective answers to questions involving the learning process, learning effectiveness, learning management system and training documentation. This position assists in ensuring proper information is available in Learning Management documentation for all conducted audits. Interfaces with process owners to ensure successful data transfer of LMS information. Advise and implement assessment submission for SOP revisions. This includes working collaboratively with SOP authors and developing assessment standards for LMS submission in a timely manner. Assist SOP Authors with information gathering for SOP submission. This includes giving guidance with training curriculums for "right the first time" with training requirements for change form submissions. Provide support and guidance as necessary for leaders who have a need to run routine reports. Support Instructional Design Activities. Support the preparation and generation of training materials such as participant guides, media, evaluations, job aids, training checklists, etc. Takes ownership of key projects and/or processes as assigned. Facilitate the coordination and scheduling of site resources for cross-functional and site-wide learning events. Gather KPI information and draft reports and visual controls that effectively display learning performance information. Assists in managing the storage and retrieval of paper-training records in accordance with regulatory and record retention policies. Minimum Qualifications Experience with a learning management system as an administrator within a GMP compliance environment Experience supporting the Training and Development Group