Hiring: Regulatory Document Coordinator and Training Manager Company: Axle Location: Bethesda, MD Job Posted Time: 2026-09-12 13:06:33 Employment Type: On-site Target Skills & Keywords : Accessibility, Program Management About the job Required Skills: •Draft, revise, and manage the full lifecycle of SOPs, Work Instructions, and Training Modules per DFOM templates and formatting standards •Maintain version control, revision history, authorship tracking, and approval status for all controlled documents in the NIH QMS system •Maintain the SOP, Work Instruction, and Training Module Master Index and Status Log; track document effective dates, review and expiration timelines, retirement, and archival •Coordinate cross-functional document reviews with subject matter experts to ensure accuracy and regulatory alignment •Oversee controlled distribution to ensure only current, approved document versions are accessible and superseded versions are restricted •Track individual employee training completion against required modules and maintain auditable training records •Generate monthly compliance reports on training status and document expiration forecasts (30/60/90-day lookahead) •Support internal and external audits by providing documentation of employee qualifications and training adherence Qualifications: •Dependent Care Assistant Program (DCAP) •Axle is hiring a Regulatory Document Coordinator and Training Manager to support NIH's Division of Facilities Operations and Maintenance (DFOM) on the Bethesda campus, managing the full lifecycle of SOPs, work instructions, and training modules for FDA-regulated Aseptic Processing Facilities and Biosafety Level containment labs. •Operational familiarity with 21 CFR Parts 210, 211, and 600 and other applicable federal regulations governing pharmaceutical and biological facilities •Knowledge of USP <797>, USP <800>, ISO 14644-4, and/or CDC BMBL guidance preferred •Demonstrated ability to coordinate multi-stakeholder review and approval workflows under defined timeframes •Strong attention to detail and ability to manage multiple document lifecycles simultaneously •Proficiency with electronic document management or quality management system (QMS) platforms •Demonstrated capacity to work on-site at the NIH Bethesda campus Compensation: •100% Medical, Dental & Vision Coverage for Employees Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!