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Manufacturing Specialist

Greystone Pk, NJ 07950

Posted: 09/18/2023 Employment Type: Contract Job Category: Scientific Job Number: 576819 Is job remote?: No Country: United States

Job Description

This role is responsible for the dispensary area tasks including kitting and material flow, inventory management, Apheresis Receipt, Final Product Packaging (FPP), and other duties required to support the core functions.

Major Accountabilities: General: Adhere to all area governing SOPs, WPs, and batch records with a focus on Right First Time performance Ensure timely and accurate data entry Maintain training compliance Ensure value stream support areas are maintained in an audit ready state Provide flow to the work support when required/available Ensure equipment cleaning and maintenance is performed per governing SOP requirements Escalate any observed compliance or safety issues and support reconciliation of event

Proficient in various operating systems, including but not limited to LIMS, SAP, MES etc. Support monthly and annual cycle count Support all site/team projects and initiatives Act in accordance with Values and Behaviors

Dispensary Activities: Ensure accurate SAP/MES inventories are maintained for all components Ensure proper status segregation and storage of all conditioned and ambient materials Ensure Kanban system is accurate and materials are consumed per FEFO/FIFO Ensure kitting/staging of initial kits are complete for each shift and timely response to kitting requests for production

Ensure all gowning materials in the ISO8 staging area are maintained to adequate levels. Ensure dispensary area has ample supply of non-BOM items

APH/Pack Activities: Receipt and inspection of incoming Leukapheresis Final product packaging and shipping On time delivery of scheduled Day 0 apheresis for patient processing Receipt and storage of final product from scheduled patient processing

Ensure inventory accuracy of GMP and non-GMP LN2 storage locations. Ensure all materials and documentation is available and accurate so not to impede daily activities Key Performance Indicators: EBR right first time Cycle Count Inventories are accurate 98% training compliance of all associates No major or critical audit findings pertinent to the ISO8, APH/Pack areas

  • 1-3years of related experience in cGMP/FDA regulated industry. Warehouse experience preferred. SAP knowledge preferred Other Qualifications: Strong interpersonal, written and communication skills along with problem solving and follow-up skills are required. Must be well organized, flexible and work with minimal supervision. Ability to lift up to 50 lbs. Alternate shifts, weekends and overtime will be required Requires handling of chemicals such as corrosives, solvents & bio-hazardous materials Values & Behaviors: Ability to adapt and learn new systems Ability to collaborate with other groups, teams and departments in addressing inventory related issues.
  • Speak Up Mentality.
  • Demonstrate a high level of discipline and self-motivation. Maintains composure during stressful situations. Provides innovative solutions to complex or process improvement issues. Education
  • High School Degree or GED equivalent.
Pay rate range: $23-$25
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