What are the responsibilities and job description for the Cell Management Specialist position at Delan Associates, Inc?
Title: Cell Management Specialist
Location: Morris Plains, NJ
Shift timings: Tuesday - Saturday, 10 AM : 6:30 PM EST & Sunday to Thursday, 10 AM : 6:30 PM EST
Job Description Summary
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.
Job Description
Key Responsibilities:
o Follow all area governing SOPs, WPs, and batch records with an emphasis on Right First-Time performance
o Ensure prompt and precise data entry
o Maintain compliance with training requirements
o Keep Manufacturing Support areas in an “audit ready” state
o Provide “flow to the work” support when needed/available
o Perform equipment cleaning and maintenance in accordance with governing SOP requirements
o Escalate and help reconcile any observed compliance or safety issues
o Be proficient in various operating systems, such as LIMS, SAP, and MES
o Support monthly and annual cycle counts
o Participate in site/team projects and initiatives
o Act according to Novartis Values and Behaviors
o Ensure accurate SAP/MES inventories for all components
o Properly segregate and store all conditioned materials
APH Receipt / Final Pack / Day 0 / Harvest Activities:
o Receive and inspect incoming leukapheresis
o Package and ship final products
o Deliver scheduled Day 0 apheresis for patient processing on time
o The Harvest and storage of final product
o Receive and store final products from scheduled patient processing
o Resolve outstanding issues with internal and external customers through follow-up communication
o Coordinate the shipping, receiving, storage, and processing of goods, possibly including imports/exports
o Verify inventory accuracy of GMP and non-GMP LN2 storage locations
o Ensure availability and accuracy of all materials and documentation to avoid impediments to daily activities
Role Requirements:
o 1-3 years of related experience in a cGMP/FDA regulated industry; warehouse experience preferred.
o High School diploma required; Bachelor's degree preferred.
o Strong interpersonal, written, and communication skills, along with problem-solving and follow-up abilities.
o Must be well organized, flexible, and able to work with minimal supervision.
o Ability to lift up to 50 lbs., assisted.
o Requires handling chemicals such as corrosives, solvents, and bio-hazardous material