Manages material needs/requirements for CAR-T production per Standard Operating Procedures (SOPs) in controlled and/or classified environments under the supervision of Warehousing Operations Management.
Material Handlers must adhere to regulatory requirements while performing job functions.
Job duties are performed within a team according to an assigned, production shift schedule.
Communication of production deviations and assistance with quality investigations are required, as applicable.
Performs inventory control: cycle counts, material stocking, scrapping, at a minimum.
Manages material expiry, allocation, kitting, and maintains material condition requirements.
Quantifies and maintains materials in production dispensary.
Performed apheresis receipt of incoming raw materials and prepares final product shipments for couriers.
Maintains timing according to the production schedule to ensure on-time logistics.
Records material handling data and information in a clear, concise, format according to proper GDPs.
Works in a team based, cross-functional environment to complete warehousing tasks required by shift schedule.
Must be able to work in an environment with blood derived components.
Other duties may be assigned, as necessary.
Performs other tasks as assigned.
Required Skills:
Bachelor's degree OR Associate/ Medical Technical degree and 0-2 years of Manufacturing or
Operations experience OR High School diploma/GED and 2-4 years of Manufacturing or Operations experience.
Knowledge of cGMP/FDA regulated industry.
Basic mathematical skills.
General understanding of cGMPs.
Technical writing capability.
Proficient in MS Office applications.
Inventory control and/or management.
Background to include an understanding of biology, chemistry, medical or clinical practices is a plus.
Available to work OT when business requires.
Flexible to work across both Summit and Warren NJ sites.
Willing to work staggered day shift hours.
WORKING CONDITIONS (US Only):
Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
Physical dexterity sufficient to use computers and documentation.
Sufficient vision and hearing capability to work in a job environment.
Ability to lift from 25- 50 pounds.
Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
Cleanroom garments and personal protective equipment will be required in designated areas which cover the head, parts of the face, core body, and legs/feet.
Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
Flexibility to clean room garments and personal protective equipment (PPE).
Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.
Routine exposure to human blood components.
Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Anthony: anthony@alphaconsulting.Com
ALPHA'S REQUIREMENT #23-00900
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
