Senior IT Associate-Quality Assurance Specialist (Contingent)

Job Responsibilities

• Support quality assurance activities for clinical research systems, ensuring compliance with applicable domestic and international regulatory requirements.
• Apply risk-based validation approaches, including GAMP methodologies, to support compliance with 21 CFR Part 11.
• Develop and maintain Computer Systems Validation (CSV) / Computer Systems Assurance (CSA) documentation, including Validation Plans, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Support regulatory inspection readiness activities, including documentation reviews, audit support, and response preparation.
• Participate in internal and external audits, inspections, and quality reviews.
• Conduct risk assessments and support risk identification and mitigation activities across systems and processes.
• Perform root cause analysis and support the development and management of Corrective and Preventive Actions (CAPA).
• Collaborate with cross-functional teams including clinical, IT, QA, and program stakeholders to ensure quality standards are consistently applied.

Basic Qualifications

• Bachelor’s degree in Life Sciences, Quality Assurance, Information Systems, or a related field.
• Minimum of 5 plus years of experience in QA, validation, or compliance within clinical research or regulated environments.
• Familiarity with domestic and international regulatory requirements for clinical research (e.g., GxP).
• Experience applying GAMP-based approaches to system validation and compliance with 21 CFR Part 11.
• Experience developing CSV/CSA documentation, including Validation Plans, IQ, OQ, and PQ.
• Understanding of regulatory inspection processes and audit support.
• Experience with risk management, root cause analysis, and CAPA processes.

Preferred Qualifications

• Master’s degree in Life Sciences, Quality Assurance, Information Systems or a related field.
• Experience supporting NIH, HHS, FDA, or other regulated federal health environments.
• Familiarity with evolving FDA Computer Software Assurance (CSA) guidance and risk-based validation approaches.
• Knowledge of clinical systems such as EDC, CTMS, or laboratory information systems.
• Relevant certifications (e.g., ASQ Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), or equivalent).
• Strong problem-solving and analytical skills in complex, multi-system environments.
• Strong communication skills, with the ability to convey technical issues to both technical and non-technical stakeholders.

Requirements

• Westat offers a well-rounded and comprehensive benefits program focused on wellness and work/life balance.
• Subject to plan requirements, employees may participate in: Employee Stock Ownership Plan 401(k) Retirement Plan Paid Parental Leave Vacation Leave (15 days per year) Sick Leave (9 days per year) Holiday Leave (7 Government Holidays and 2 Floating Holidays) Professional Development Health Advocate Employee Assistance Program Travel Accident Insurance Medical Insurance Dental Insurance Vision Insurance Short Term Disability Insurance Long Term Disability Insurance Life and AD&D Insurance Critical Illness Insurance Supplemental Life Insurance Flexible Spending Account Health Savings Account

Pay Range

The anticipated salary range for this position is $96,000 - $102,000 and will commensurate with experience.