Cell Management Specialist

LanceSoft Inc

Morris Plains, NJ

JOB DETAILS
JOB TYPE
Full-time
SKILLS
Apheresis, Cleaning Equipment, Communication Skills, Current Good Manufacturing Practice (cGMP), Customer/Consumer Behavior, Data Entry, Documentation, Equipment Maintenance/Repair, FDA (Food and Drug Administration), Follow Through, GMP (Good Manufacturing Practices), Hazardous Materials/Substances, High School Diploma, Import/Export, Interpersonal Skills, Inventory Cycle Counts, Inventory Management, Laboratory Information Management System (LIMS), Lift/Move 50 Pounds, Maintain Compliance, Manufacturing Requirements, Operating Systems, Organizational Skills, Problem Solving Skills, Product Packaging, Product Shipments, Receiving Inspection, Regulatory Compliance, SAP, Safety Compliance, Shipping/Receiving, Standard Operating Procedures (SOP), Team Player, Time Management, Warehousing, Writing Skills
LOCATION
Morris Plains, NJ
POSTED
28 days ago
Job 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 Pay Rate: *** - ***/Hour (Lowest would be better) 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 Client 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.

About the Company

L

LanceSoft Inc

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2000
WEBSITE
http://www.lancesoft.com/