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Job description
Back Quality Management Analyst
Health Information Technology Rockville , MD Sep 11, 2026
Quality Management Analyst
Hybrid
Blu Omega is seeking a Quality Management Analyst to support the National Institute of Allergy and Infectious Diseases (NIAID) within the NIH. This role is responsible for providing independent quality oversight for GxP-regulated computerized systems within enterprise clinical informatics systems support services.
Key Details
Location:Rockville, MD - One day per week onsite
Clearance / Suitability: Public Trust eligibility required
Responsibilities
Provide independent quality oversight for the implementation, validation, maintenance, and retirement of GxP-regulated computerized systems
Apply knowledge of GxP regulations, including CSA and CSV, to guide teams in compliance
Collaborate with cross-functional stakeholders to ensure systems meet regulatory and quality standards
Support testing activities, incident management, and validation documentation
Required Qualifications
3+ years of experience working in a GxP IT environment or GxP Quality Assurance
Experience with GxP quality standards and regulatory requirements such as GAMP5, CSA, 21 CFR Part 11, and ICH E6 (R2)
Direct experience supporting GxP IT projects and testing, including validation plans, IQ/OQ/PQ, and validation documentation
Experience writing SOPs and providing training to teams and stakeholders
Ability to obtain Public Trust clearance
Preferred Qualifications
Experience with electronic test execution software, vendor assessments, and internal audits
Knowledge of GxP impact assessments, system risk assessments, validation, and 21 CFR Part 11 assessments
Certified Quality Auditor, Quality Engineer, ISO Lead, or related certification
Compensation
Salary Range: $82,000.00 - $102,000.00
Final compensation is based on technical skills, experience, education, certifications, and clearance.
Blu Omega Benefits & Perks
Medical, Dental, and Vision coverage through national providers
401(k) with company match (eligible after 6 months; vesting applies)
Company-paid Life and AD&D insurance with additional voluntary options
Short-term disability (company-paid) and long-term disability options
Employee Assistance Program (EAP) with 24/7 confidential support and mental health resources
Telehealth and virtual care options available through medical plans
Pet insurance, legal services, and identity theft protection options
Paid Time Off (PTO) for eligible employees
Paid federal holidays for salaried employees
Access to wellness programs, discounts, and lifestyle benefits
Benefits eligibility and offerings may vary based on role, employment status, and program requirements
Company Overview
Blu Omega is a Woman-Owned Small Business (WOSB) delivering technology and cybersecurity solutions to federal agencies and enterprise clients nationwide. Headquartered in Ashburn, VA, we support mission-critical programs across civilian and defense sectors, including health, national security, and regulatory environments.
We partner with government agencies and large integrators to provide expertise in cybersecurity operations, cloud and infrastructure modernization, data and analytics, and enterprise IT support.
Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability.
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Worksite address
rockville, MD, 20849, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.