Associate Specialist CAR T Warehouse Kitting and Dispensing - Warren

Employment Type

: Full-Time

Industry

: Warehousing/Logistics



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Regular

Role Description:

The Associate Specialist of CAR-T Warehouse, Kitting, and Dispensing reports to the Senior Manager of CAR-T Warehouse, Kitting, and Dispensing. This role is accountable to warehouse facility, and materials movement, kitting, and dispensing operations for a multi-product clinical manufacturing facility for Celgene Chimeric Antigen Receptor (CAR) T-cell Therapies and will be an individual contributor. Responsible for implementing and owning documentation of materials management, inventory control/cycle counts, shipping/receiving, and kitting and dispensing including training, SOPs, deviations, and CAPAs to maintain a compliant, effective, and efficient operations that meet or exceeds site goals and objectives.

Required Competencies: Knowledge, Skills, and Abilities

  • Proficiency in desktop applications (PowerPoint, Word, Outlook, Excel, SharePoint)
  • Proficiency in process mapping and documentation
  • Proficiency in user requirement documentation
  • Intermediate written and verbal communication skills
  • Problem-solving aptitude with attention to detail
  • Basic presentation development and delivery skills
  • Basic knowledge of cGxP regulations
  • Basic knowledge of computerized system testing
  • Basic knowledge of warehouse operations
  • Basic knowledge of S&OP processes
  • Ability to work independently for extended periods of time
  • Ability to work collaboratively as a team member
  • Ability to interpret / write technical documents
  • Ability to gown into Grade C and D classified environments
  • Ability to travel < 10% of time
  • Duties and Responsibilities
  • Own Warehouse, Kitting, and Dispensing SOPs, Deviations, CAPAs.
    Support Business Operations and Supply Chain Organization in collecting and analyzing data to improve processes, reporting and communication.
    Assist in the development and creation of communication plans across departmental areas. Coordinate activities and project milestones to implement changes and improvements.
    Collects, analyzes and reports key information impacting the site supply chain operations.
    Collaborate with departmental leads to create, manage and publish KPIs and metrics.
    Lead the development of a communication plan that keeps internal stakeholders appropriately informed of departmental initiatives and progress reports.
  • Create and manage departmental SharePoint sites to facilitate collaboration and communication across Cellular Therapy Organizations.
  • Collaborate with site and departmental management to develop business requirements for business process improvements within site operations.
  • Performs business impact assessment on changes to business systems (ERP, MES, boundary systems) and processes.
  • Executes User Acceptance Testing for any system warehouse, kitting, dispensing operations.
  • Collaborate internal and external departments to gather business requirements, prioritize, develop, design, create data source definitions and deliver reports from ERP or Ad Hoc reporting tool(s).
  • Provides training to users on departmental applications.
  • Develop business process models, process maps, process outlines and documentation to assist in evaluating and optimizing business operations.
  • Seek and support continuous process improvement
  • Maintain and update site procedures and supporting documentation for supply chain operations functions.
  • Perform other tasks as assigned.
  • Education and Experience
  • Bachelors degree in a related field from an accredited college or university required (Science or Supply Chain Degree preferred)
  • 1+ year relevant work experience required, preferably in a pharmaceutical manufacturing environment
  • An equivalent combination of education, experience and training may substitute for a degree
  • Working Conditions
  • 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.
  • 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.
  • 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.




    Associated topics: clerk, coordinator, entry level, logistics operation, operator warehouse, supply chain, trainee, unloading, warehouse agent, warehouse intern

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