GxP IT Compliance Analyst — Validation, Audits & Risk

Celltrion Inc; Branchburg Township (NJ); Hybrid; USD 71,250 - 116,000; Full time

Benefits offered by this job

Paid time off

Medical, dental, and vision insurance

Company-matched retirement savings plan

Job summary

Celltrion Inc in Branchburg Township, NJ is seeking an IT Compliance Analyst responsible for supporting products while ensuring regulatory compliance. This role collaborates with IT teams to enhance compliance strategies and improve systems.

The ideal candidate will have 5+ years of IT experience, including 2+ years in Life Sciences, strong regulatory knowledge, and the ability to manage multiple projects. Benefits include a comprehensive package with paid time off and medical insurance.

Qualifications

• 5+ years of IT or relevant experience.
• Minimum of 2 years in the Life Sciences industry.
• Excellent knowledge of pharmaceutical regulations.

Responsibilities

• Ensure compliance with GxP requirements and internal SOPs.
• Oversee validation strategy for computerized systems.
• Lead system risk assessments and regulatory classification.

Skills

Project management

Regulatory knowledge

Analytical skills

Collaboration

Education

BS/BA in Computer Science or related field

Tools

Oracle

SQL

Windows

Job description

Celltrion Inc in Branchburg Township, NJ is seeking an IT Compliance Analyst responsible for supporting products while ensuring regulatory compliance. This role collaborates with IT teams to enhance compliance strategies and improve systems.

The ideal candidate will have 5+ years of IT experience, including 2+ years in Life Sciences, strong regulatory knowledge, and the ability to manage multiple projects. Benefits include a comprehensive package with paid time off and medical insurance.