Regulatory Document Coordinator and Training Manager
Manages the controlled lifecycle of regulatory SOPs, Work Instructions, and training modules for NIH aseptic processing and biosafety facilities. The role coordinates reviews and approvals, maintains auditable document and training records, monitors compliance, and supports audits.
About the job
Responsibilities
- Manage the creation, drafting, review, revision, approval, distribution, retirement, expiration, and archival of SOPs, Work Instructions, and Training Modules.
- Maintain version control, authorship, revision history, approval status, effective dates, and expiration timelines in NIH’s document control system.
- Coordinate cross-functional reviews with subject matter experts and stakeholders to verify accuracy and alignment with DFOM policies, regulatory requirements, and industry standards.
- Ensure only current, approved document versions are accessible and restrict or remove superseded and expired versions.
- Link training modules to supporting SOPs and Work Instructions.
- Track employee training completion, maintain auditable training records, monitor required timeframes, and generate compliance and assessment reports.
- Support internal and external audits by providing employee qualification and training-adherence documentation.
- Produce master indexes, status logs, review forecasts, distribution confirmations, quarterly status reports, annual summaries, and QMS account-management reports.
Compensation
- Base salary: $90,000–$100,000 USD annually
- Medical, dental, and vision coverage; paid time off and holidays; 401(k) match up to 5%; educational benefits; employee referral bonus; and flexible spending accounts.
Skills
Document Control, Standard Operating Procedures, Work Instructions, Training Modules, Version Control, Quality Assurance, Regulatory Compliance, Audit Support, Training Records, Compliance Reporting
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