Quality Management Specialist

Booz Allen Hamilton•Rockville, MD

About The Position

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 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.

Requirements

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

Nice To Haves

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