USA - Manufacturing Specialist - Abacus Service Corporation
Morris Plains, NJ 07950
About the Job
Description:
Cell Management Specialist
Location: On-Site - Morris Plains, NJ
The Cell Management Specialist is responsible for Apheresis Receipt, Final Product Packaging (FPP), Day 0 and Harvest transfers. Inventory Management and other duties required to support the core functions.
Key Responsibilities:
" 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 Manufacturing 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 Client Values and Behaviors Dispensary Activities
" Ensure accurate SAP/MES inventories are maintained for all components
" Ensure proper status segregation and storage of all conditioned materials
APH Receipt / Final Pack / Day 0 / Harvest 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
Follow-up communication to resolve outstanding issues with internal and external customers
Coordination of shipping, receiving, storage and processing of goods. May include imports/exports.
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
Role Requirements:
" 1-3 years of related experience in cGMP/FDA regulated industry; warehouse experience preferred.
" High School degree required. Bachelor's degree preferred.
" 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., assisted.
" Requires handling of chemicals such as corrosives, solvents & bio-hazardous material.
Rotational shift
Days: Tuesday - Saturday or Sunday - Thursday
has context menu
Cell Management Specialist
Location: On-Site - Morris Plains, NJ
The Cell Management Specialist is responsible for Apheresis Receipt, Final Product Packaging (FPP), Day 0 and Harvest transfers. Inventory Management and other duties required to support the core functions.
Key Responsibilities:
" 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 Manufacturing 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 Client Values and Behaviors Dispensary Activities
" Ensure accurate SAP/MES inventories are maintained for all components
" Ensure proper status segregation and storage of all conditioned materials
APH Receipt / Final Pack / Day 0 / Harvest 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
Follow-up communication to resolve outstanding issues with internal and external customers
Coordination of shipping, receiving, storage and processing of goods. May include imports/exports.
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
Role Requirements:
" 1-3 years of related experience in cGMP/FDA regulated industry; warehouse experience preferred.
" High School degree required. Bachelor's degree preferred.
" 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., assisted.
" Requires handling of chemicals such as corrosives, solvents & bio-hazardous material.
Rotational shift
Days: Tuesday - Saturday or Sunday - Thursday
has context menu
| Hours per Day | 8 |
|---|---|
| Hours per Week | 40 |
| Total Hours | 2,736.00 |
Source : Abacus Service Corporation