Management Analyst

Capefox•Bethesda, MD

7d•Onsite

About The Position

Cape Fox Facilities Services is seeking a qualified Management Analyst to join our team. The Management Analyst (Regulatory Document Coordinator and Training Manager) shall provide facility and building support services for the Division of Facilities Operations and Maintenance (DFOM), Oﬃce of the Director (OD), by serving as the DFOM/APF/BSL Document Coordinator and Training Manager. This position provides critical support for federal-regulation-mandated documentation and quality control/assurance necessary to operate and maintain the National Institutes of Health (NIH) Aseptic Processing Facilities (APFs) and Biosafety Level (BSL) containment facilities.

Requirements

Bachelor's degree in a related field
Six (6) years related experience
Experience coordinating/managing training and providing document control
Personnel training and Compliance Tracking
Document management
Personnel actions
Authorization to work in the United States

Responsibilities

Manage the full lifecycle of Standard Operating Procedures (SOPs), Work Instructions (WIs), and Training Modules for DFOM's APF and BSL operations, including initial creation and drafting, coordination of periodic review cycles, management of the revision process, facilitation of the approval process, management of distribution, and management of document retirement and expiration.
Utilize the NIH document control system to ensure compliance with organizational and regulatory recordkeeping requirements, including maintenance of detailed version control records, tracking of authorship, maintenance of complete revision history, tracking of approval status, recording and monitoring effective dates, and monitoring of document expiration timelines.
Coordinate document review activities and manage controlled access to current documentation, including coordination of cross-functional reviews, verification of document content consistency with current DFOM policies and procedures and applicable industry standards and regulatory requirements, and oversight of controlled distribution processes.
Track and manage personnel training status in direct linkage with the document control system, including linking Training Modules to specific SOPs and WIs, tracking individual employee training status, monitoring completion within designated timeframes, maintaining auditable training records, generating compliance reports, and supporting internal and external audits.