Job Title: Cell Management Specialist
Location: Morris Plains, NJ
Duration: 09 months
Shift timings: Sunday - Thursday, 06:00 am to 2:30 pm EST
Job Description:
· The Cell Management Specialist is tasked with Apheresis Receipt, Final Product Packaging, Day 0 and Harvest transfers, Inventory Management, and other duties essential to support core functions.
Key Responsibilities:
· Follow all area governing SOPs, WPs, and batch records with an Client on Right First-Time performance
· Ensure prompt and precise data entry
· Maintain compliance with training requirements
· Keep Manufacturing Support areas in an “audit ready” state
· Provide “flow to the work” support when needed/available
· Perform equipment cleaning and maintenance in accordance with governing SOP requirements
· Escalate and help reconcile any observed compliance or safety issues
· Be proficient in various operating systems, such as LIMS, SAP, and MES
· Support monthly and annual cycle counts
· Participate in site/team projects and initiatives
· Act according to client Values and Behaviors
· Ensure accurate SAP/MES inventories for all components
· Properly segregate and store all conditioned materials
APH Receipt / Final Pack / Day 0 / Harvest Activities:
· Receive and inspect incoming leukapheresis
· Package and ship final products
· Deliver scheduled Day 0 apheresis for patient processing on time
· The Harvest and storage of final product
· Receive and store final products from scheduled patient processing
· Resolve outstanding issues with internal and external customers through follow-up communication
· Coordinate the shipping, receiving, storage, and processing of goods, possibly including imports/exports
· Verify inventory accuracy of GMP and non-GMP LN2 storage locations
· Ensure availability and accuracy of all materials and documentation to avoid impediments to daily activities
Role Requirements:
· 1-3 years of related experience in a cGMP/FDA regulated industry; warehouse experience preferred.
· High School diploma required; Bachelor's degree preferred.
· Strong interpersonal, written, and communication skills, along with problem-solving and follow-up abilities.
· Must be well organized, flexible, and able to work with minimal supervision.
· Ability to lift up to 50 lbs assisted.
· Requires handling chemicals such as corrosives, solvents, and bio-hazardous material.