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:
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- 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 timeframes.
- 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- Management of document retirement and expiration, including archival of superseded or obsolete documents.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:
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- 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.
The Management Analyst (Regulatory Document Coordinator and Training Manager) shall coordinate document review activities and manage controlled access to current documentation, including:
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:
The total hourly pay for this exempt position is $55.00-$57.00 for up to 40 hours per week. This rate represents the company’s good faith and reasonable estimate of possible compensation at the time of posting. In addition, for eligible positions we offer a variety of benefits including specified holidays, paid leave, health insurance, dental insurance, vision insurance, life and disability insurance, tuition reimbursement, as well as 401K with company match. This job will be posted until filled or withdrawn.
