Data Analyst

3 hours, 53 minutes ago
Lead
Data Science and Analytics
Orion Innovation

Orion Innovation

Orion Innovation is a global technology services provider specializing in digital transformation, offering solutions in data, analytics, enterprise collaboration, risk & compliance, and cloud services to enhance productivity and decision-making.

IT Services
1K-5K
Founded 1993

Description

  • Support the creation, review, and approval of CSV deliverables for custom in-house solutions.
  • Maintain close communication with Business, IT, and Quality stakeholders to track CSV needs, compliance impacts, and project status.
  • Create documentation that follows existing document standards and client SOPs.
  • Obtain, address, and incorporate feedback from cross-functional reviewers.
  • Follow SOPs and industry best practices throughout validation activities.
  • Use MS Office, Visio, and related technology platforms to support project documentation and execution.
  • Work with electronic document management, application lifecycle management, and IT service management systems such as Qumas, SharePoint, ALM, JIRA, and ServiceNow.
  • Support the use of AI as an accelerator for document creation, review, and testing.
  • Help validation leads ensure required deliverables and testing are completed for enterprise GxP systems.

Requirements

  • Bachelor’s degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, or a related scientific or technical discipline.
  • 8–10+ years of experience in pharmaceutical, biotechnology, or regulated manufacturing environments.
  • 7+ years of experience in project management, commercial operations, or launch operations within the pharmaceutical or biotech industry.
  • 5+ years of experience with Data Integrity/ALCOA+ principles.
  • 5+ years of experience with CSA principles.
  • 5+ years of experience with technical writing.
  • Working knowledge of GMP, GLP, and GAMP 5 principles.
  • Strong understanding of FDA regulations, ICH guidelines, and EU Annex 11, as applicable.
  • Experience developing, executing, and reviewing validation protocols and reports, risk assessments, SOPs, deviation investigations, and CAPAs.
  • Ability to support regulatory inspections and audits, including FDA, EMA, internal, or client audits.
  • Proficiency with common pharmaceutical documentation systems and tools such as EDMS and change control systems.
  • Experience with current digital validation tools; familiarity with AI as an accelerator is a plus.
  • Strong written and verbal communication skills and the ability to facilitate cross-functional meetings.
  • Ability to learn new platforms quickly; training on Lx systems and tools will be provided.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

Senior Data Analyst

K2 Space Corporation 51-200 Defense and Space Manufacturing

K2 Space is seeking a Senior Data Analyst to turn enterprise and operational data into actionable insights that support satellite design, manufacturing, and mission operations.

Power BI Python Snowflake SQL Tableau
2 hours, 53 minutes ago

Workforce Management Analyst

Figma 1K-5K Internet Software & Services

Figma is hiring a Workforce Management Analyst to support Product Support operations by managing capacity planning, vendor performance, and data-driven staffing decisions across internal and outsourced teams.

Looker Python SQL
3 hours, 8 minutes ago

FBS - Learning Measurement & Analytics Lead

Capgemini 100K+ Internet Software & Services

Learning Measurement & Analytics Lead at a major U.S. insurer, responsible for building the company’s learning evaluation strategy and proving the business impact of learning investments across the organization.

Power BI Python R Tableau
3 hours, 38 minutes ago

ALG Head of Impact

ALU 251-1K Specialty Retail

African Leadership Group is seeking a Head of Impact to build a trusted, scalable evidence and validation engine for its education and workforce development programs.

Statistics
1 day, 3 hours ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers