Booz Allen is looking to solve quality management issues in a GxP IT environment by applying knowledge of GxP regulations and guidelines with specific emphasis on computer software assurance (CSA) and computer system validation (CSV)
Requirements
- 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 with MasterControl preferred
- Experience with Computer Software Assurance preferred
- Certified Quality Auditor, Quality Engineer, ISO Lead, or a related Quality Certification preferred
- Experience with GxP IT environment or GxP Quality Assurance
- Experience with writing SOPs, audit plans, audit reports, validation plans, installation qualifications (IQ), operational qualifications (OQ), and performance qualifications (PQ)
Responsibilities
- Execute technical reviews, regulatory analysis, and systematic assessment of quality driven processes and procedures
- Determine and develop approaches to solutions independently, and when required work effectively with key stakeholders
- Lead GxP training, quality audits, and assessments, including GxP systems and process audits
- Support QMS activities, such as CAPAs, Training, Root Cause Analysis, Change Management, Document Control, and Deviations
- Support IT Projects, such as GxP Systems Quality Assurance or QMS
- Write SOPs, audit plans, audit reports, validation plans, installation qualifications (IQ), operational qualifications (OQ), and performance qualifications (PQ)
- Provide training to cross-functional teams and key stakeholders
Other
- Ability to obtain and maintain a Public Trust or Suitability/Fitness determination based on client requirements
- Bachelor's degree
- Possession of excellent planning and organizational skills
- Possession of excellent oral and written communication skills
- Public Trust
