Data Analyst
Lawrence Township, New Jersey, United States
USD 87K-145K (estimate) Senior-level Full Time
Tasks
- Conduct risk assessments including FMEA
- Create documents to existing standards
- Develop and review SOPs deviations investigations and CAPAs
- Develop execute and review validation protocols and reports
- Follow SOPs and industry best practices
- Maintain stakeholder communication for CSV needs and impacts
- Manage documentation in electronic document management systems
- Obtain and respond to reviews from business IT and quality
- Support creation review and approval of CSV deliverables
- Support regulatory inspections and audits
- Use MS Office and Visio for documentation
Perks/Benefits
- N/A
Skills/Tech-stack
ALCOA plus | Annex 11 | CAPA | CSA | Change Control | Computer system | Computer system validation | Data Integrity | Deviation Management | Document Management System | EU Annex 11 | Electronic Document Management System | Electronic document management | FDA Regulations | FMEA | GAMP 5 | GLP | GMP | GxP | ICH Guidelines | Jira | Management System | Microsoft Office | Risk Assessment | S&OP | ServiceNow | SharePoint | System validation | Technical writing | Validation Protocol | Validation Report | Visio
Education
Roles
Analyst | Data Analyst | Data Integrity Specialist | Specialist
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