Purpose and Scope of Position

Manages cold chain and patient material receipt, release, dispensing, inventory, and shipping for CAR-T production per Standard Operating Procedures (SOPs) in controlled and/or classified environments under the supervision of Supply Chain Operations Management. The position must adhere to regulatory requirements while performing job functions. Job duties are performed in alignment with CAR-T production schedules, may require weekend work. Communication and initiation of production deviations and assistance with quality investigations are required, as applicable. Overtime may be required at management discretion including on weekends.

Required Competencies: Knowledge, Skills, and Abilities
o Ability to work as team
o Intermediate written and verbal communication and mathematical skills
o Introductory Proficiency in MS Office applications
o Inventory control and management including lot / batch segregation, expiration dating, and temperature storage requirements
o Advanced warehouse management system experience
o Background to include an understanding of biology, chemistry, medical or clinical practices preferred, not required
o ERP experience preferred, not required
Duties and Responsibilities
o Records patient material handling / operations data and information in a clear, concise, format according to proper cGxP requirements
o Performs inspection and receipt of incoming patient materials per cold chain shipping requirements in coordination with defined specifications and in collaboration with Incoming Quality Control
o Performs inventory control: cycle counts, material stocking, scrapping, destruction
o Completes inventory / material transfer and movement within facility
o Manages material expiry, lot / batch control, allocation and maintains material condition requirements
o Maintains timing according to the production schedule to ensure on-time material transfers and availability
o Completes transactions within an electronic data management system, i.e. Oracle
o Performs inspection and receipt of incoming Apheresis and PBMC and prepares final product shipments for couriers
o Quantifies and maintains materials in production dispensary.
o Perform apheresis receipt of incoming raw materials and prepares final product shipments for couriers.
o Maintains timing according to the production schedule to ensure on-time logistics.
o Records material handling data and information in a clear, concise, format according to proper GDPs.
o Works in a team based, cross-functional environment to complete warehousing tasks required by shift schedule.
o Must be able to work in an environment with blood derived components.
o Completes training requirements in accordance to defined schedule / curricula
o Periodically reviews and provides input on revisions to SOPs related to functional responsibilities
o Provides support for investigations and issue resolution
o Assists with resolution of inbound issues (receiving, suspect damages, shipment errors)
o Identifies process and performance improvement opportunities
o Collaborates cross functionally with Manufacturing, Quality, Materials Management, Process & Technology.
o Other duties may be assigned, as necessary
Education and Experience (As Applicable)
o Bachelors degree and 3 years of applicable Pharma experience
o An equivalent combination of education, experience and training may substitute
o Must have a valid driver's license
Working Conditions (US Only)

Physical Requirements

• Must be able to work in a cleanroom environment and perform aseptic processing
• Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
• Ability to crouch, bend, twist, and reach
• Physical dexterity sufficient to use computers and documentation
• Must be able to work in Lab setting with biohazards/ various chemicals/ strong magnets
• Ability to stand /sit/walk for long periods of time and work different hours of the day
• Ability to lift/ push/ pull 50 lbs independently
• Must be able to perform activities with repetitive motions
• Must be able to wear clean room garments and personal protective equipment (PPE).
• Must be comfortable being exposed to human blood components.
• Maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements. Must be comfortable in a clean room environment, which is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.
• Based on work assignment, may be recommended (or required) to have medical and visual screening testing in accordance with the companys Occupational Health Program

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

Job Type: Contract

Salary: $25.00 - $34.00 per hour

Schedule:

• 8 hour shift
• Overtime
• Weekend availability

Experience:

• Medical Material Handling: 5 years (Preferred)

Work Location: One location

Speak with the employer
+91 8474991237

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