Quality Assurance Associate Ii, Contingent Worker

Kincell Bio

Gainesville, FL, United States
On-site
7+ years relevant industry experience
Review of production batch records
Adherence to cgmps and gdp
Kincell Bio engineers cells into therapies and is a contract development and manufacturing organization focused on immune cell therapies

Job Summary

  • Kincell Bio engineers cells into therapies and is a contract development and manufacturing organization focused on immune cell therapies.
  • The role involves overseeing the generation and revision of product-related master documents to support GMP manufacturing of drug substances and products.
  • The position requires supporting regulatory audits and inspections while maintaining databases for tracking lot disposition.

Matching Summary

Kincell Bio engineers cells into therapies and is a contract development and manufacturing organization focused on immune cell therapies.

Skills & Requirements

Must-have

  • 7+ years relevant industry experience
  • Review of production batch records
  • Adherence to cGMPs and GDP
  • Support deviation CAPA change control
  • Track executed documents across sites

Nice-to-have

  • Experience with FDA EMA audits
  • Knowledge of electronic computer systems
  • Ability to work in fast-paced environment
  • Strong cross-functional communication skills
  • Exposure to biotechnology industries

Key Requirements

  • HS Diploma with 7+ years experience
  • Bachelor's degree preferred in life sciences
  • Experience in Document Control position
  • Knowledge of 21 CFR Parts 210 & 211
  • Microsoft Word and Excel proficiency

Work Rights

Not specified

Tailored Resume

Cover Letter