Location: Newark,NJ, USA
100% onsite position Work Schedule: 2nd shift (2:00pm-10:30pm) M-F Driving onsite and forklifting required PURPOSE AND SCOPE OF POSITION: 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. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities: - 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 Education and Experience: - 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. DUTIES AND RESPONSIBILITIES: - Performs inventory control: cycle counts, material stocking, scrapping, at a minimum. - Fork Lifting - 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. - 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 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 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 don 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.