Regulatory Document Coordinator

Objective:

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The contractor staff 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.

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Duties and Responsibilities:

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1) Requirement Area 1 — Document Lifecycle Management

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The contractor staff shall manage the full lifecycle of Standard Operating Procedures (SOPs),

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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

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DFOM templates and formatting standards.

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• Coordination of periodic review cycles to ensure documents remain current and

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technically accurate.

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• Management of the revision process, including tracking requested changes and

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incorporating approved edits.

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• Facilitation of the approval process, ensuring required approvers review and sign off

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within established timeframes.

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• Management of distribution to ensure approved documents reach relevant personnel

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(see Requirement Area 3 for controlled distribution specifics).

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• Management of document retirement and expiration, including archival of superseded

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or obsolete documents.

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2) Requirement Area 2 — Document Control and Records Management

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The contractor staff shall utilize the NIH document control system that ensures compliance with

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organizational and regulatory recordkeeping requirements, including:

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• Maintenance of detailed version control records for all SOPs, WIs, and Training Modules.

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• Tracking of authorship for each document and revision.

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• Maintenance of complete revision history for each controlled document.

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• Tracking of approval status (pending, approved, rejected, returned for revision) for each

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document in the workflow.

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• Recording and monitoring effective data for all approved documents.

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• Monitoring of document expiration timelines and proactive initiation of review or

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archival processes as review/expiration dates approach.

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3) Requirement Area 3 — Cross-Functional Review Coordination and Controlled Distribution

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The contractor staff shall coordinate document review activities and manage controlled access to

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current documentation, including:

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• Coordination of cross-functional reviews involving relevant subject matter experts and

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stakeholders to ensure document accuracy.

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• Verification that document content is consistent with current DFOM policies and

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procedures.

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• Verification that document content aligns with applicable industry standards and

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regulatory requirements (see Section 3).

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• Oversight of controlled distribution processes to ensure that only the most current,

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approved versions of documents are accessible to relevant personnel.

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• Removal or restriction of access to superseded or expired document versions.

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4) Requirement Area 4 — Personnel Training Management and Compliance Tracking

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The contractor staff shall track and manage personnel training status in direct linkage with the

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document control system, including:

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• Linking of Training Modules to the specific SOPs and WIs they support.

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• Tracking of individual employee training status against required modules.

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• Monitoring to ensure all employees complete required training within designated

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timeframes.

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• Maintenance of up-to-date, auditable training records for all applicable personnel.

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• Generation of compliance reports summarizing training completion status across

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DFOM/APF/BSL personnel.

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• Support of internal and external audits by providing documentation of employee

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qualifications and training adherence upon request.