Summary :
The Senior QA Systems Specialist is responsible for overseeing, supporting, and administering Quality Management Systems (QMS).
This role ensures the systems are effective, efficient, and maintained to support GxP functions. This position will support end users, manage QA requirements, oversee account management, and evaluate changes for implementation and continuous improvement initiatives.
W2 applications only.
Essential Duties and Responsibilities :
- Analyze user enhancement requests to develop solutions that improve business processes, increase efficiency, and enable automation and growth within the organization.
- Document user and functional requirements to inform system improvements and enhancements.
- Participate in authoring and executing implementation plans, developing solutions, and managing project / change timelines.
- Perform User Acceptance Testing (UAT), Performance Qualification (PQ), and validation testing as applicable.
- System Administration :
- Manage system access and permissions.
- Conduct change management activities.
- Design solutions and manage system configuration.
- Liaise with users to resolve issues promptly.
- Create reports based on defined requirements and maintain system documentation.
- Maintain end-user support information and manage updates to business guidance and user reference documentation.
- Identify opportunities for improved monitoring and user issue resolution to deliver better value to customers.
- Assist with activities related to internal and external audits / inspections.
- Support initiatives related to Computer System Validation and the Data Integrity program.
- Oversee and maintain integration tools with the Learning Management System, ComplianceWire, if applicable.
Qualifications :
- Bachelor’s degree in science or a related field with a minimum of 7 years of relevant experience; or an equivalent combination of education and experience.
- At least 5 years of experience working with validated applications in a pharmaceutical or regulated environment.
- Strong knowledge of quality and regulatory business processes.
- Direct experience implementing GxP computerized systems and maintaining validated states.
- General knowledge of System Administration with the Veeva Platform (Quality QMS, Quality QDocs).
- Experience with other regulated applications, such as Learning Management Systems and Quality Management Systems.
- Working knowledge of SaaS systems.
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