Job Description
Westat is a leader in research, data collection and analysis, technical assistance, evaluation, and communications. Our evidence-based findings help clients in government and the private sector accelerate advancements in health, education, transportation, and social and economic policy. Our dedication to improving lives through research and our approach to projects grounded in investigative curiosity, statistical and data rigor, adaptive methods, and advanced technology are why clients find exceptional value in our work.
Job Summary:
Westat is seeking a Quality Assurance (QA) Specialist (Senior IT Associate) to support an NIH program focused on clinical research systems and regulatory-compliant technology delivery. This role is responsible for ensuring that systems, processes, and documentation meet domestic and international regulatory requirements. The ideal candidate brings experience in computer systems validation/assurance, inspection readiness, and risk-based quality management within clinical research environments. This position is contingent upon the award of the contract.
This position has a hybrid arrangement to work onsite at our Bethesda office 3 days per week and 2 days per week from your home office.
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.
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
Any offer of employment may be contingent upon receipt of acceptable results from a post-offer background screening, if required for the specific position, which may include, for example, identity verification, employment history, motor vehicle driving record history, and criminal or sexual offender records history. Any background screening results will be evaluated through an individualized assessment based on the individual's specific record and the duties and requirements of the position.
This opportunity will be posted for a minimum of 5 days and applications will be accepted on an ongoing basis.
Employment Eligibility: This is a U.S.-based position. Candidates must be authorized to work in the United States on a full-time basis. Westat does not offer employment-based visa sponsorship (including H-1B sponsorship) for this role. Depending on project requirements, some positions may require employees to meet specific residency criteria.
Westat is an Equal Opportunity Employer and does not discriminate on the basis of race, creed, color, religion, sex, national origin, age, veteran status, disability, marital status, sexual orientation, citizenship status, genetic information, or any other protected status under applicable law. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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Westat
medical insurance, dental insurance, life insurance, vision insurance, flexible benefit account, parental leave, vacation time, sick time, short term disability, long term disability, 401(k), retirement plan
May 05, 2026