The Assistant Specialist, Sample Management, is responsible for the movement and control of QC samples and materials in support of the QC laboratories at the CAR T manufacturing facility in Summit, NJ. This includes, but is not limited to, management of liquid nitrogen tank inventory, sample collection and distribution, inventory control, chain of custody, sample tracking, and sample delivery.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities: • Experience with cold chain sample storage and transfer. • Experience working in a GMP regulated environment. • Ability to work in a classified cleanroom environment and follow all applicable gowning requirements and procedures. • Ability to follow and apply global regulatory and GMP requirements. • Ability to follow SOPs. • Ability to work in a collaborative team environment. • Ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.
Education and Experience: • 2+ years of relevant work experience, preferably in a regulated/cGMP environment. • An equivalent combination of education and experience may substitute.
DUTIES AND RESPONSIBILITIES:
Responsible for cryopreservation and management of including: • Handling patient material throughout the material Cryopreservation, storage, distribution, transfer, and disposal. • Maintaining sample tracking and chain of custody records in accordance with GMP requirements and written procedures. • Ensuring that obsolete or expired samples and materials are destroyed and disposed of according to written procedures. • Performing sample queries and periodic storage reports, as required. • Assisting management with investigations and deviations related to sample management. • Collaborating with other departments to identity and implement process efficiencies. • Maintaining metrics for the Value Stream Cryo Operations group. • Facilitating cold chain transfers of material, as required. • Performs tasks for Cell Therapy products to support product Value Stream outputs according to Current Good Manufacturing Practices (cGMP's) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs).
The job requires handling cryo-stored patient materials in and out of storage tanks. Carrying between 10 to 30lbs of cryo-storage materials.
Please let me know what her response is EOD.
WORKING CONDITIONS (US Only): • The incumbent should be able to distinguish colors and possess correctable vision to 20/20. • The incumbent will be doing light to moderate lifting, carrying, or moving objects under
15-20 lbs. • The incumbent will be working in a laboratory setting up to eight hours per day. • The incumbent will be working around biohazardous materials, including chemical agents, up to eight hours per day • The incumbent may be exposed to fluctuating and/or extreme temperatures on occasion.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.