Booz Allen Hamilton · 2 weeks ago
Quality Management Specialist
Rockville, MD
Full-time
Hybrid
Mid Level
$55K/yr - $126K/yr
3+ years expBooz Allen Hamilton is a leading consulting firm specializing in quality management and assurance. They are seeking a Quality Management Specialist to apply knowledge of GxP regulations, manage quality events, and ensure compliance with quality standards and regulatory requirements.
ConsultingCyber SecurityIT InfrastructureManagement ConsultingSecurity
No H1B
Security Clearance Required
Responsibilities
Apply knowledge of GxP regulations and guidelines with specific emphasis on computer software assurance (CSA) and computer system validation (CSV)
Leverage expertise with an electronic Quality Management System (eQMS), functioning as a Training Manager, Quality Events Manager, or Document Control Specialist
Execute technical reviews, regulatory analysis, and systematic assessment of quality driven processes and procedures
Use independent judgment to accomplish objectives and be self-motivated and directed
Determine and develop approaches to solutions independently and work effectively with key stakeholders when required
Qualification
Required
3+ years of experience working in GxP Quality Assurance or a GxP IT environment
Experience with quality standards and regulatory requirements, including GAMP5, CSA, 21 CFR Part 11, and ICH E6(R2)
Experience with an electronic QMS
Experience supporting QMS activities such as CAPAs, training, root cause analysis, change management, document control, and deviations
Experience leading GxP training, quality audits, and assessments, including GxP systems and process audits
Experience supporting IT projects such as GxP Systems Quality Assurance or QMS
Experience writing SOPs, audit plans, audit reports, validation plans, installation qualifications (IQ), operational qualifications (OQ), and performance qualifications (PQ)
Experience providing training to cross-functional teams and key stakeholders
Ability to obtain and maintain a Public Trust or Suitability/Fitness determination based on client requirements
Bachelor's degree
Preferred
Experience with MasterControl
Experience with CSA
Possession of excellent planning and organizational skills
Possession of excellent verbal and written communication skills
Public Trust
Certified Quality Auditor, Quality Engineer, ISO Lead, or similar Quality Certification
Benefits
Health
Life
Disability
Financial
Retirement benefits
Paid leave
Professional development
Tuition assistance
Work-life programs
Dependent care
Company
Booz Allen Hamilton
Booz Allen Hamilton is a consulting firm that specializes in analytics, technology, and engineering.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$3.03B2025-03-11Post Ipo Debt· $650M
2023-08-01Post Ipo Debt· $650M
2020-08-13Post Ipo Debt· $700M
Leadership Team
Matthew Calderone
Chief Financial Officer and Executive Vice President
Kristine Anderson
Chief Operating Officer
Recent News
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