Cape Fox Facilities Servicesis 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), Oce 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
This SOW is organized into distinct requirement areas. Each area is independently dened below; collectively they constitute the full scope of the required support.
- Requirement Area 1 - Document Lifecycle Management
- 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 o within established timeframes.
- Management of distribution to ensure approved documents reach relevant personnel (see Requirement Area 3 for controlled distribution specics).
- Management of document retirement and expiration, including archival of superseded or obsolete documents.
- Requirement Area 2 - Document Control and Records Management
- 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 workow.
- Recording and monitoring eective 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
- Coordination of cross-functional reviews involving relevant subject matter experts and stakeholders to ensure document accuracy.
- Verication that document content is consistent with current DFOM policies and procedures.
- Verication 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
- Linking of Training Modules to the specic SOPs and WIs they support.
- Tracking of individual employee training status against required modules.
- Monitoring to ensure all employees complete required training within designated timeframes.
- Maintenance of up-to-date, auditable training records for all applicable personnel.
- Generation of compliance reports summarizing training completion status across DFOM/APF/BSL personnel.
- Support of internal and external audits by providing documentation of employee qualications and training adherence upon request.
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.