Quality Management Specialist

Quality Management Specialist

Key Role : Apply knowledge of GxP regulations and guidelines with specific emphasis on computer software assurance (CSA) and computer system validation (CSV). Leverage experience 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 when required work effectively with key stakeholders.

Basic Qualifications :

• 3+ years of experience working in a GxP IT environment or GxP Quality Assurance
• Experience with quality standards and regulatory requirements, including GAMP5, Computer Software Assurance, 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 with supporting IT Projects, such as GxP Systems Quality Assurance or QMS
• Experience with 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

Additional Qualifications :

Vetting : Applicants selected will be subject to a government investigation and may need to meet eligibility requirements of the U.S. government client.

Compensation : At Booz Allen, we celebrate your contributions, provide you with opportunities and choices, and support your total well-being. Our offerings include health, life, disability, financial, and retirement benefits, as well as paid leave, professional development, tuition assistance, work-life programs, and dependent care. Our recognition awards program acknowledges employees for exceptional performance and superior demonstration of our values. Full-time and part-time employees working at least 20 hours a week on a regular basis are eligible to participate in Booz Allen's benefit programs. Individuals that do not meet the threshold are only eligible for select offerings, not inclusive of health benefits. We encourage you to learn more about our total benefits by visiting the Resource page on our Careers site and reviewing Our Employee Benefits page.

Salary at Booz Allen is determined by various factors, including but not limited to location, the individual's particular combination of education, knowledge, skills, competencies, and experience, as well as contract-specific affordability and organizational requirements. The projected compensation range for this position is $55,200.00 to $126,000.00 (annualized USD). The estimate displayed represents the typical salary range for this position and is just one component of Booz Allen's total compensation package for employees.

This posting will close within 90 days from the Posting Date.

Identity Statement : As part of the application process, you are expected to be on camera during interviews and assessments. We reserve the right to take your picture to verify your identity and prevent fraud.

Work Model : Our people-first culture prioritizes the benefits of flexibility and collaboration, whether that happens in person or remotely.

Commitment to Non-Discrimination : All qualified applicants will receive consideration for employment without regard to disability, status as a protected veteran or any other status protected by applicable federal, state, local, or international law.