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.