Cell Management Specialist

Title: Cell Management SpecialistLocation: Morris Plains, NJShift timings: Tuesday - Saturday, 10 AM : 6:30 PM EST & Sunday to Thursday, 10 AM : 6:30 PM ESTJob Description SummaryThe 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 DescriptionKey Responsibilities:o Follow all area governing SOPs, WPs, and batch records with an emphasis on Right First-Time performanceo Ensure prompt and precise data entryo Maintain compliance with training requirementso Keep Manufacturing Support areas in an “audit ready” stateo Provide “flow to the work” support when needed/availableo Perform equipment cleaning and maintenance in accordance with governing SOP requirementso Escalate and help reconcile any observed compliance or safety issueso Be proficient in various operating systems, such as LIMS, SAP, and MESo Support monthly and annual cycle countso Participate in site/team projects and initiativeso Act according to Novartis Values and Behaviorso Ensure accurate SAP/MES inventories for all componentso Properly segregate and store all conditioned materialsAPH Receipt / Final Pack / Day 0 / Harvest Activities:o Receive and inspect incoming leukapheresiso Package and ship final productso Deliver scheduled Day 0 apheresis for patient processing on timeo The Harvest and storage of final producto Receive and store final products from scheduled patient processingo Resolve outstanding issues with internal and external customers through follow-up communicationo Coordinate the shipping, receiving, storage, and processing of goods, possibly including imports/exportso Verify inventory accuracy of GMP and non-GMP LN2 storage locationso Ensure availability and accuracy of all materials and documentation to avoid impediments to daily activitiesRole 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