Manufacturing Technician

 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.
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Job Description

Key Responsibilities:

·       Follow all area governing SOPs, WPs, and batch records with an emphasis 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.