The Sr GxP Systems Analyst will support the management of GxP applications throughout the system lifecycle. This includes but is not limited to day-to-day troubleshooting, applications support, system administration, solution configuration, managing customizations, data security, data integrity GxP compliance, and CSV support.
Additionally, this position is a business partner to multiple business functions responsible for problem resolution. The role may also interact with external service providers, collaborating and aligning on general management of GXP applications.
The incumbent in this position must be able to research and resolve difficult and complex problems.
System Administration and Support
Support the system administration of GxP applications in the our clients environment, including but not limited to Master Control, Trackwise Digital, Tracelink, Part 11 DocuSign, Veeva, Argus.
Support the analysis, design, development and installation of GxP applications in accordance with established SOPs.
GxP Computer System administration, escalation point, and maintenance support.
Prepare, review, and approve GxP Computerized Systems Validation lifecycle documents as an IT GxP SME.
Demonstrate the ability to work systematically and logically to analyze situations, resolve problems, identify causes, and anticipate implications.
Support analysis, resolution of Incident Management and technical investigations.
Follow companys change management process to comply with ITGC policies.
Business-Technology Process Management
Functional and technical requirement gathering, gap analysis and documentation for GXP applications.
Documents and assist users in defining business requirements, process maps, and use cases
Organize and execute analysis, design/configuration, implementation and delivery of GxP Applications.
Actively participating in Project Meetings and serves as a Project Manager as needed
Provide weekly project status reports and milestone target schedules.
Secure approvals, follow change management process and track functional changes needed for audit review.
Effectively interface with system business owners of GxP systems and provide technical support
IT GxP SME who partners with QA on managing GxP enterprise applications throughout all phases of the system development lifecycle, including concept, design, implementation/validation, and operation
Effectively interface with vendor support and maintenance & operation of the GxP systems
Functional Enhancement Management
Prepare Function Design Documents as part of necessary configuration or development changes/needs
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
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At least 8 years of hands-on technical IT experience
Minimum additional 5 years of experience supporting GxP (GMP, GLP, GCP) computerized systems in the biopharmaceutical/pharmaceutical industries.
Associate's degree in a related field or relevant experience
Full understanding of CFR Part-11 rules and their application to regulated and validated (GxP) systems
Full understanding of Computer System validation methodology.
Experience in requirements definition and analysis and flow charting.
Familiarity with System Development Lifecycle and GAMP5 methodology
Excellent communication and interpersonal skills. Must be comfortable supporting employees at all levels of the organization.
Ability to work independently and efficiently with minimal supervision.
Proactive team player who gets along easily with others and enjoys collaborating.
o Experience with standard industry platforms/systems such as MasterControl, DocuSign 21 CFR Part 11, Veeva, TrackWise, ServiceNow etc.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.