A Step Closer to Potential Dialysis Prevention
Senior GMP Data Analytics Analyst
Location
North Carolina
Posted
8 days ago
Salary
Not specified
Job Description
Job Requirements
- Bachelor’s Degree.
- Minimum of 5-10 years of experience in IT experience working in the role of business and technical analyst with the focus on data, business intelligence, and analytics projects
- Experience working in Biotech/Pharma (Regulated Industry)
- Experience with developing requirements, design, and testing documents.
- Hands-on experience with data analysis and reporting in support of Pharmaceutical GMP environment.
- Understanding of GMP data sources across pharmaceutical manufacturing process and quality control testing environment sources such as Laboratory Management Information Systems, Quality Systems, Manufacturing Execution Systems, Data Historian, and other tools.
- Experience with design and development and usage of data repository and analytics platforms
- Demonstrated experience managing lifecycle documentation and validation in FDA-regulated environments.
- Versed in FDA/Industry regulations and policies (Part 11, Computer System Validation)
- Experience with system administration responsibilities
- Experience with helping lead data analysis and engineering projects
- Ability to work under tight timelines
- Ability to communicate and work across teams in collaborative manner
- Ability to work independently with minimal supervision.
- GxP, Pharmaceutical Manufacturing and Quality Data (GMP data), Data analysis and reporting
- Understanding of data modeling tools
- Experience working with analytics (Python, R, Excel, Tableau, Spotfire, other reporting and analytics for manufacturing process industries)
- Experience with database (SQL) and ETL development
- Experience with cloud environments (AWS, Azure)
- Experience with usage of process analytic software is a plus (Aveva, Seeq).
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