Associate Scientist Quality Control, Sample Management - CAR T Program
Newark 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.
Required Competencies: Knowledge, Skills, and Abilities
Experience with sample storage and transfers
Ability to work on weekends or weekdays
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
Duties and Responsibilities
Responsible for movement of QC test samples including receipt, storage, distribution, transfer and disposal
Maintain sample tracking and chain of identity and custody records in accordance with cGMP requirements and written procedures
Ensure that expired samples/materials are destroyed/disposed of according to written procedures
Performs sample queries and periodic storage reports as required
Assist management with investigations and deviations related to sample management
Collaborate with teams to identify and implement process improvements
Assist with maintaining inventory of lab supplies, reagents, media, consumables, etc.
Ensure that materials are appropriately labelled and traceable as per appropriate cGMP, regulatory requirements, and written procedures
Assist management with investigations and deviations related to lab inventory
Maintain 5S and FIFO principles as appropriate
QC Materials Support
Support sample management metrics
Facilitate cold chain sample transfers as required
Liaise with supply chain, warehouse and lab services to ensure supply stocks
Education and Experience
Bachelor s Degree required, preferable in Science
2+ years of relevant work experience; preferable 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