Senior GxP Application Analyst
US-Emeryville, CA OR Remote
Dynavax is a fully-integrated biopharmaceutical company dedicated to developing and commercializing innovative vaccines to prevent disease. Our vision and work ethic are guided by the collective ideals underpinning our corporate values, and these form the basis of our dynamic company culture. Our employees are based throughout the United States (including our headquarters in the San Francisco Bay Area) and our manufacturing facility in Düsseldorf Germany.
The Senior GxP Applications Analyst is responsible for day-to-day system administration, solution configuration, compliance, support, data integrity and management of GXP applications. The Senior GxP Application Analyst understands business challenges and opportunities and works to lead the configuration and maintenance of value-added solutions to meet the set business requirements. Additionally, this position is responsible for troubleshooting and problem resolution, GxP compliance, management and monitoring of system resources and performance, and support and maintenance of all environments related to GxP applications. While the primary focus will be on GXP applications, a willingness to learn and support additional IT business applications, such as Atlassian Jira, Confluence, MS Teams and SharePoint, is important.
System Administration and Support
- System administration of GxP applications in the Dynavax environment, including but not limited to Master Control, Trackwise Digital, Tracelink, Part 11 DocuSign, Veeva eTMF, Argus.
- Support the analysis, design, development and installation of corporate GxP applications in accordance with established SOPs.
- Manage user access, roles, privileges and security enhancements.
- Demonstrate the ability to work systematically and logically to analyze situations, resolve problems, identify causes, and anticipate implications.
- Investigates problems with GxP applications, diagnose root causes, and resolve issues.
- Support analysis, resolution of Corrective/Preventative Actions (CAPA) investigations.
- Support user ‘how-to’ questions, walk through steps and train users as needed.
- Analyzes business process issues and improvements and provides solution recommendations in a timely manner.
- Follow company’s change management process to comply with ITGC policies.
- Assist as needed in external/internal audits and inspections
- Provide weekly project status reports and milestone target schedules
- Manage relationship with external level two support resources, manage escalation process and jointly troubleshoot issues.
Business-Technology Process Management
- Documents and assist users in defining business requirements, process maps, and use cases
- Secure approvals, follow change management process and track functional changes needed for audit review
- Investigate feature requests, clarify objectives, understand software functionality, and recommend solutions using industry best practices
- Functional and technical requirement gathering, gap analysis and documentation for GXP applications
- Organize and execute analysis, design/configuration andimplementation ofGxP applications upgrades
- Analyze and document current and future GxP system adminstration processes
Functional Enhancement Management
- Prepare Function Design Documents as part of necessary configuration or development changes/needs
- Configure GxP Applications to meet business requirements
- Manage project tasks to implement enhancements and functional changes.
- Perform unit test, business process transactional test and controls tests and prepare documentation for approval.
- Assist programmers and developers through designing, programming, testing, deploying, maintaining, and supporting User initiatives
- Maintain system of internal controls, perform periodic testing and document procedures and results in accordance Quality requirements
- BA or BS degree in Computer Science/Information Systems or equivalent experience
- 7-10 years of GXP Applications systems support experience
- Hands on experience in diverse areas including implementation, migration, training & troubleshooting
- Experience in gap analysis and requirements gathering
- Excellent organization and time management skills, ability to prioritize demands and multi-task to complete objectives. Ability to be flexible and creative.
- High level of attention to detail
- Ability to build relationships with our internal and external partners/customers
- Demonstrate integrity, maturity, and a constructive approach to challenges
- Ability to adapt to changing technical and business requirements
- Ability to read and understand complex technical documents and procedures
- Excellent communication, project management & presentation skills
- Excellent Documentation Skills
- Appropriate handling of confidential information
- Worked with teams of developers
- Ability to work on-call, or respond after-hours required.
- 2-3 years of experience supporting Atlassian Jira and Confluence a plus
- Ability to stand or sit for prolonged periods.
- Must be able to perform repeating motions that may include the wrists, hands and/or fingers.
- Occasional travel required, as needed.
- Full COVID-19 vaccination is required for this position.
Dynavax is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.