Quality Management Analyst

Blu Omega LLC; Rockville (MD); Hybrid; USD 82,000 - 102,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) with company match

Life and AD&D insurance

Disability insurance

EAP with mental health resources

Telehealth

Pet insurance

Paid Time Off

Paid federal holidays

Wellness programs

Job summary

Blu Omega LLC is seeking a Quality Management Analyst to support the National Institute of Allergy and Infectious Diseases (NIAID) within NIH. The role provides independent quality oversight for GxP-regulated computerized systems in enterprise clinical informatics support services, located in Rockville, MD with hybrid onsite requirement.

The candidate will apply GxP principles (CSA, 21 CFR Part 11) and guide teams to regulatory compliance, contribute to validation documentation, and assist with

Qualifications

• 3+ years in a GxP IT or QA environment.
• Experience with GxP standards: GAMP5, CSA, 21 CFR Part 11, ICH E6(R2).
• Experience supporting GxP IT projects including validation plans and IQ/OQ/PQ.
• Experience writing SOPs and training teams.

Responsibilities

• Provide independent quality oversight for the implementation, validation, maintenance, and retirement of GxP-regulated computerized systems.
• Apply knowledge of GxP regulations 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.

Skills

GxP compliance

Regulatory knowledge

Documentation

SOP writing

Tools

Electronic test execution software

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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