Newark Metro Area, NJ
1. Purpose and Scope of Position
The Global Product Quality Associate II (Stability Coordinator) is responsible for supporting stability programs and compliance related activities for CAR T products. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, author protocols/reports, and troubleshoot.
2. Required Competencies: Knowledge, Skills, and Abilities
Detail oriented with high degree of focus.
Able to follow instructions and procedures, both written and verbal.
Able to perform with minimal supervision and contribute in a team environment.
Able to communicate results and issues effectively, both written and orally.
Knowledge and ability in using Microsoft Office Package.
Excellent technical writing and verbal communication skills required
Familiarity with techniques of cell biology, biochemistry, or Immunology; first-hand laboratory experience is a plus.
Ability to work with multiple complex projects and within cross-functional teams.
Working knowledge of change control processes
3. Education and Experience
Bachelor s degree required, preferably in: Immunology, Biology,
Advanced Degree preferred.
5-8 years of relevant work experience, preferably in a regulated environment.
An equivalent combination of education and experience may substitute.