Senior IT Business Systems Analyst, Laboratory Systems
1 month ago
The Senior IT Business Systems Analyst, Quality Systems is responsible for supporting daily operations of the IT Quality Technologies to include QC Labs (LIMS, CDS, Infrastructure, etc.), Quality Management System (QMS), and IT System Compliance and Validation. This role will partner with IT Technology Owners, IT Infrastructure, as well as the Quality business. This individual will play a key role supporting daily operations, new technology selection/introduction, design/development, deployment, and maintenance/support and upgrades/software releases of existing install Quality Technologies.
Key Responsibilities/Essential Functions
Support Daily Quality Operations Technologies
Possess a strong understanding of Quality Technologies/operations such as QMS, LIMS, CDS, and other Quality systems
Write/Maintain System Administration and Maintenance SOPs
Develop/Maintain Quality Technology Data Analytics and Dashboards
Gather, develop, clarify, and document functional/user business requirements
Transform the users’ requirements into functional requirements
Experience working with QC and QMS systems, preferably LabVantage, Empower, Veeva, TrackWise, MasterControl, etc.
Collaborate with Technology System Owners, Business Owners and Project Managers on issues, concerns, schedules of deliveries and completion estimates and execution
Experience working in GxP validated environments supporting and executing validation requirements
Skills and Experience and Education
BA/BS degree in Information Technology or Computer Science with 2-5+ years' progressive
experience in a Technology discipline within pharma, biotech, medical device or diagnostics.
Experience in the following areas preferred: QC Lab Systems, Quality Management Systems & Document Management, Quality Assurance, Computer Systems Validation, GxP, Validated Change Control and Product Life Cycle Management.
Understanding of Computer Systems Validation and the Software Life Cycle management
Strong written and verbal communication skills.
Strong collaboration skills with the ability to work in a team dynamic across multiple functional organizations.
Experience in the life science industry or like industry essential
Demonstrated analytical, troubleshooting, and problem-solving skills.
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