Sample Management Associate Scientist
Edison-New Brunswick Metro Area, NJ
Purpose and Scope of Position
The Associate Scientist for QC Sample Management works with supervision and is responsible for the movement of samples and materials in support of the CAR T Quality Control laboratories. This includes, but is not limited to, sample collection and distribution, inventory control, maintaining chain of custody and sample tracking. The position is in a regulated environment following current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs) and aseptic techniques.
This position will work weekends, or weekdays and some Holidays to support a 7 day a week operation.
Shifts are generally 4 days a week, 10 hours per day; Sunday to Wednesday or Wednesday to Saturday.
Required Competencies: Knowledge, Skills, and Abilities
Experience with sample storage and transfers
Ability to work on weekends or weekdays with flexible shift hours
Experience with LIMS sample management system; or equivalent is helpful
Experience with WORD, PowerPoint, Excel is helpful
Ability to don appropriate gowning and work in classified cleanroom environment
Ability to work in a collaborative team environment
Prior experience and ability to follow and apply Global Regulatory and cGMP requirements
Ability to adapt and adjust to changing priorities and to meet deadlines
Ability to follow, review and revise SOPs
Education and Experience
Bachelor s Degree required; preferably in a Science related field
2+ years of relevant work experience; preferably in a regulated cGMP environment
An equivalent combination of education and experience may substitute
The incumbent will be required to work 40 hours per week, with a combination of weekends and weekdays.
The incumbent will be doing light to moderate lifting of objects under 15-20lbs
The incumbent will be working in a laboratory and clean room environment.
The incumbent will be working around biohazardous materials, wearing scrubs and other gowning requirements.
The incumbent should be able to distinguish colors and possess correctable vision to 20/20