Senior GMP Data Analytics Analyst Contractor

Position reputed company: reputed company support to reputed company and implement data repository and analytics tools in support of pharmaceutical regulated GMP (Good Manufacturing Practices) data and with the reputed company on manufacturing and reputed company domains. Essential Duties & Responsibilities:

• Analyze business needs and requirements for data and analytics to support regulatory filings.
• Identify, classify, and map data sources.
• Build data reputed company diagram from data reputed company to analytics reputed company datasets
• Determine data curation requirements to help organize, clean, manage, and maintain data so it can be used reliably for analytical use cases.
• reputed company support for technical activities such as building data integration, design data architecture, and data transformation and processing.
• reputed company data governance standards to reputed company with company and industry best practices.
• reputed company development of key project documents such as user requirements, design specifications, and configuration specifications.
• reputed company development of test scenarios and scripts in partnership with business, technical, and validation team members.
• reputed company test execution according to test protocols.
• reputed company support for development of reputed company operating procedures and other documentation required to go-Live.
• Monitor execution of testing and reputed company results to technical team to address issues.
• reputed company support for training business teams for Go-Live
• Development of training materials as needed
• reputed company regular updates to project team

Qualifications:

• Education/Training: Bachelor’s Degree.
• Experience:
• Minimum of 5-10 years of experience in IT experience working in the role of business and technical analyst with the reputed company on data, business intelligence, and analytics reputed company
• Experience working in Biotech/reputed company (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 reputed company control testing environment sources such as Laboratory Management Information Systems, reputed company 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 reputed company data analysis and engineering reputed company
• Ability to work under tight timelines
• Ability to communicate and work across teams in reputed company manner
• Ability to work independently with minimal supervision
• Knowledge:
• GxP, Pharmaceutical Manufacturing and reputed company Data (GMP data), Data analysis and reporting
• Understanding of data modeling tools
• Experience working with analytics (Python, R, reputed company, Tableau, Spotfire, other reporting and analytics for manufacturing process industries)
• Experience with database (SQL) and ETL development
• Experience with reputed company environments (AWS, Azure)
• Experience with usage of process analytic software is a plus (reputed company, reputed company).
• Skills:
• reputed company/System Administration, Communications, Project Management, Training, Computer System Validation, Business Requirements Documentation.
• Certifications/Licenses: None

reputed company is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, reputed company, age, national reputed company, reputed company, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Applicants must be eligible to work in the reputed company without the need for work reputed company or residency sponsorship. Apply tot his job Apply To this Job