(ID: 2026-3436)
Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Benefits We Offer:
- 100% Medical, Dental & Vision Coverage for Employees
- Paid Time Off and Paid Holidays
- 401K match up to 5%
- Educational Benefits for Career Growth
- Employee Referral Bonus
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
Overview
Axle is hiring a Regulatory Document Coordinator and Training Manager to support NIH's Division of Facilities Operations and Maintenance (DFOM) on the Bethesda campus, managing the full lifecycle of SOPs, work instructions, and training modules for FDA-regulated Aseptic Processing Facilities and Biosafety Level containment labs.
Responsibilities
- Draft, revise, and manage the full lifecycle of SOPs, Work Instructions, and Training Modules per DFOM templates and formatting standards
- Maintain version control, revision history, authorship tracking, and approval status for all controlled documents in the NIH QMS system
- Maintain the SOP, Work Instruction, and Training Module Master Index and Status Log; track document effective dates, review and expiration timelines, retirement, and archival
- Coordinate cross-functional document reviews with subject matter experts to ensure accuracy and regulatory alignment
- Oversee controlled distribution to ensure only current, approved document versions are accessible and superseded versions are restricted
- Track individual employee training completion against required modules and maintain auditable training records
- Generate monthly compliance reports on training status and document expiration forecasts (30/60/90-day lookahead)
- Support internal and external audits by providing documentation of employee qualifications and training adherence
- Produce quarterly program status reports and an annual program summary for COR and DFOM leadership
Requirements
- Experience managing document control systems (QMS) in a regulated environment (FDA, GMP, or equivalent)
- Familiarity with 21 CFR Parts 210, 211, and 600 and other applicable federal regulations governing pharmaceutical and biological facilities
- Knowledge of USP <797>, USP <800>, ISO 14644-4, and/or CDC BMBL guidance preferred
- Demonstrated ability to coordinate multi-stakeholder review and approval workflows under defined timeframes
- Experience tracking personnel training compliance and generating audit-ready records
- Strong attention to detail and ability to manage multiple document lifecycles simultaneously
- Proficiency with electronic document management or quality management system (QMS) platforms
- Ability to work on-site at the NIH Bethesda campus
Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact: [email protected]
This role has a market-competitive salary with an anticipated base compensation range listed below. Actual salaries will vary depending on a candidate’s experience, qualifications, skills, and location.
What We Do
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, health informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we develop and apply research tools and techniques that empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH) by offering the responsiveness of a small business coupled with the experience, breadth, and depth of a large organization.
