Operations Associate, Cell Therapy Supply Chain Devens, MA

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This Operations Associate Cell Therapy Supply Chain role is responsible to perform Supply Chain operations in direct support to the manufacture of Cell Therapy products. These operations may include:

Final storage of finished Cell Therapy drug product into cryogenic storage
Receipt and processing of incoming patients apheresis material
Packaging of finished drug product into cryogenic shipper for shipment to patient
Performance of material cleaning and kitting operations to ensure continuous supply of raw materials and consumables to support the manufacture of Cell Therapy products
Execution of warehouse activities including goods receipt raw material put-away and material disposal

The scope of the role is for Supply Chain night shift operations in support of commercial and clinical products manufactured at the Devens MA Cell Therapy Facility.

Shifts Available:

A2 6pm 6am rotational shift including holidays and weekends

Responsibilities:

Responsibilities may include but are not limited to the following:

General Work Activities

Maintain a safe work environment and wear appropriate personal protective equipment (PPE)
Deliver the right material to the right location at the right time while adhering to good manufacturing practices and standard operating procedures. The ability to recognize deviation from accepted practice is required.
Perform routine Material Operations activities across the Cell Therapy Facility including cleaning and replenishment of materials kit building inventory cycle counting and warehouse activities.
Perform activities to directly support the manufacture of commercial and clinical Cell Therapy products:
Final storage of finished Cell Therapy drug product into cryogenic storage
Receipt and processing of incoming patients apheresis material
Packaging of finished drug product into cryogenic shipper for shipment to patient

Documentation

Complete CGMP forms and/or paper/electronic batch records
Perform SAP transactions as required and per SOP to build kits replenish materials cycle count inventory and transfer material between bin locations
General understanding of working with controlled documentation in a Document Management System
Review incoming material paperwork for incoming patient material (apheresis) receipt
Use good documentation practices (GDocP) for all activities
Demonstration and general understanding of the concept and importance of Chain of Identity (COI)

Collaborate & Partner

Interact effectively with Materials Operations Staff Quality Control Quality Assurance and Manufacturing.
Collaborate with cross-functional employees & department managers to solve work-related problems and perform run-the-business activities
Support the event escalation and triage process as it relates to deviations & CAPAs

Work Requirements

Shift is 12hr (6PM 6AM); Panama schedule to coveroperations
Operate in a commercial CGMP multi-product environment
Job requires standing and walking within and between grade classified suites
Expectation of approximately 90% of time is spent in the operations space where the work is executed
Don Personal Protective Equipment (PPE) and specialized gowning as required by procedures & signage. May work with hazardous material requiring additional PPE including respiratory protection (employee must be physically capable to wear a respirator)
Must be able to follow all controlled gowning requirements for entrance to suites with various grade level classifications (Grade 8 and CNC)