Management Analyst

Management Analyst

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.

This SOW is organized into distinct requirement areas. Each area is independently defined below; collectively they constitute the full scope of the required support.

• Requirement Area 1 — Document Lifecycle Management

The Management Analyst (Regulatory Document Coordinator and Training Manager) hall 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 of new SOPs, WIs, and Training Modules in accordance with DFOM templates and formatting standards.
• Coordination of periodic review cycles to ensure documents remain current and technically accurate.
• Management of the revision process, including tracking requested changes and incorporating approved edits.
• Facilitation of the approval process, ensuring required approvers review and sign off within established time frames.
• Management of distribution to ensure approved documents reach relevant personnel (see Requirement Area 3 for controlled distribution specifics).
• Management of document retirement and expiration, including archival of superseded or obsolete documents.
• Requirement Area 2 — Document Control and Records Management

The Management Analyst (Regulatory Document Coordinator and Training Manager) shall utilize the NIH document control system that ensures compliance with organizational and regulatory recordkeeping requirements, including:

• Maintenance of detailed version control records for all SOPs, WIs, and Training Modules.
• Tracking of authorship for each document and revision.
• Maintenance of complete revision history for each controlled document.
• Tracking of approval status (pending, approved, rejected, returned for revision) for each document in the workflow.
• Recording and monitoring effective data for all approved documents.
• Monitoring of document expiration timelines and proactive initiation of review or archival processes as review/expiration dates approach.
• Requirement Area 3 — Cross-Functional Review Coordination and Controlled Distribution

The Management Analyst (Regulatory Document Coordinator and Training Manager) shall coordinate document review activities and manage controlled access to current documentation, including:

• Coordination of cross-functional reviews involving relevant subject matter experts and stakeholders to ensure document accuracy.
• Verification that document content is consistent with current DFOM policies and procedures.
• Verification that document content aligns with applicable industry standards and regulatory requirements (see Section
  3).
• Oversight of controlled distribution processes to ensure that only the most current, approved versions of documents are accessible to relevant personnel.
• Removal or restriction of access to superseded or expired document versions.
• Requirement Area 4 — Personnel Training Management and Compliance Tracking

The Management Analyst (Regulatory Document Coordinator and Training Manager) shall track and manage personnel training status in direct linkage with the document control system, including:

• Linking of Training Modules to the specific SOPs and WIs they support.
• Tracking of individual employee training status against required modules.
• Monitoring to ensure all employees complete required training within designated time frames.
• Maintenance of up-to-date, auditable training records for all applicable personnel.
• Generation of compliance reports summarizing training completion status across…