QC Associate Scientist, QC Incoming
Newark Metro Area, NJ
Purpose and Scope of Position
Under supervision, the QC Associate Scientist is responsible for supporting the testing and release of incoming materials used in CAR-T manufacturing during clinical and commercial phases. Additionally, when needed, provide support with the authoring of technical documentations.
Required Competencies: Knowledge, Skills, and Abilities
Ability to follow and apply Global Regulatory and cGMP requirements.
Ability to author technical documents using company QC templates.
Knowledge of analytical techniques such as HPLC, GC, FTIR, Osmolarity and pH, hands-on experience preferred.
Ability to meet timelines in all assigned projects and acclimate to changing priorities.
Ability to follow, review and revise SOPs.
Ability to work in a collaborative team environment.
Ability to recognize and communicate simple and complex problems with relevant team member, department management and cross-functional peers.
Education and Experience
Bachelor s Degree required, preferably in Science.
2+ years of relevant work experience, preferably in a regulated environment.
An equivalent combination of education and experience may substitute.
The incumbent should be able to distinguish colors and possess correctable vision to 20/20, annual eye exam is required.
The incumbent must analyze numerical values on a daily basis.
The incumbent will be working a laboratory setting up to six (6) hours per day.
The incumbent will be working around biohazardous materials, including chemical agents up to six (6) hours per day.
The incumbent will be doing light to moderate lifting of objects under 15-20lbs