Not specified; annual bonus opportunities availabl...
On-site
Veeva lims experience required
Gmp and fda 21 cfr part 11 compliance
Quality control laboratory environment
This role serves as the primary business user for the Veeva Laboratory Information Management System within the Quality Control group to support gene therapy programs
Job Summary
This role serves as the primary business user for the Veeva Laboratory Information Management System within the Quality Control group to support gene therapy programs.
The position is responsible for building test definitions, generating Certificates of Analysis, and ensuring data integrity in compliance with GMP and FDA regulations.
Forge Biologics offers comprehensive benefits including health insurance starting day one, 12 weeks of paid parental leave, and an onsite fitness facility.
Matching Summary
This role serves as the primary business user for the Veeva Laboratory Information Management System within the Quality Control group to support gene therapy programs.
Salary
Not specified; Annual bonus opportunities available; 401(k) with company match
Skills & Requirements
Must-have
Veeva LIMS experience required
GMP and FDA 21 CFR Part 11 compliance
Quality Control laboratory environment
Certificate of Analysis generation
System validation and testing scripts
Nice-to-have
AAV manufacturing process knowledge
Database management principles
Data governance understanding
Regulatory inspection support experience
SOP development and training skills
Key Requirements
AS or BS in Life Sciences or Computer Science
Experience in GxP-regulated laboratory environment
Familiarity with enterprise LIMS platforms like Veeva
Knowledge of FDA 21 CFR Part 11 and data integrity
Ability to work onsite 2-3 days per week in Columbus