GxP Quality & Validation Analyst (Hybrid)

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

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