Position Title: Validation Analyst
Reporting to: Director, Regulatory and Compliance Services
Position Summary: The Validation Analyst is an entry-level technical position that reports to the Director, Regulatory and Compliance Services.
The Validation Analyst is responsible for understanding software validation in a government regulated environment with special attention to the Software Development Lifecycle (SDLC) validation processes which meet regulatory requirements. The Validation Analyst will provide support to Senior Validation Analysts and Advisors in all areas of IT Software Validation activities. They will work with internal staff in implementation of improved capabilities in the areas of documentation, coding and validation, will assist in performing analysis of current validation situations, review internal controls, create policies and procedures to ensure validation is in compliance with applicable State and Federal guidelines and policies, and will respond promptly to external and internal concerns; implementing corrective actions as appropriate
The Validation Analyst will be familiar with IT Software Validation regulatory expectations. Attention to detail is expected to ensure high quality documentation.
The position requires a high level of integrity as this person is working on a client’s project and preparing documents that may be submitted to regulatory agencies (FDA, EMEA) as needed, and actions impact the quality and reliability of the client’s’ product.
- Assess client’s current validation processes
- Perform risk assessments on current client’s validation processes
- Propose validation improvement suggestions
- Compose and document validation strategies; Validation Plans, Risk Assessments, Traceability Matrices, Roles & Responsibilities, and other validation documents as needed.
- Compose training files and prepare validation training courses for client employees and consultants
- Review documentation for accuracy and completeness
- Entry-level position
- Science or Legal background helpful.
- Bachelor’s degree in a scientific field
- Other advanced degree in science (MS or PhD) would be helpful.
- Strong problem solving and communication skills.
- Broad knowledge of SDLC systems
- Working knowledge of how to effectively perform software validation in an FDA regulated environment.
- Strong document development skills including technical writing capabilities
- Strong interpersonal skills
- High sense of integrity
- Entrepreneurial spirit