Position Title:   Associate, Patient Materials Operations, MSS
Duration: 06 Months
Location:    Summit West, S-12, 07901

Shifts: 

Associate, Patient Materials Operations (SUN-WED- 6am- 430pm)

 

Position Summary:
Handles patient material needs/requirements for CAR-T production per Standard Operating Procedures (SOPs) in controlled and/or classified environments under the supervision of Patient Materials Operations Management. Specialist 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.

Key Responsibilities:

• Performs tasks for Cell Therapy products to support product Value Stream outputs according to Current Good Manufacturing Practices (cGMP’s) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs).

• Maintains timing according to the production schedule to ensure on-time logistics.

• Performs apheresis receipt of patient materials and prepares final product shipments for couriers.

• Executes receipt and discard of ex-US Peripheral Blood Mononuclear Cells (PBMC) and ex-US Cryopreserved Material (CMAT).

• Supports Sample Retrieval, Sample Movements, and Sample Storage.

• Supports transfers of Manufactured Goods to off-site facility.

• Supports manual and electronic batch record executions, deviation investigations, and closure of CAPAs.

• Maintains timing according to the production schedule to ensure on-time logistics.

• Ensures all documentation is correct and addresses procedural/documentation errors expeditiously and effectively.

• Work with management to ensure adequately trained personnel are available to perform all manufacturing activities.

• Records patient material handling data and information in a clear, concise, format according to proper GDPs.

• Able to problem solve with minimal supervision.

• Works in a team based, cross-functional environment to complete 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.

• Willing to work staggered day shift hours.

Qualification & 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.

WORKING CONDITIONS (US Only):
•    The incumbent should be able to distinguish colors and possess correctable vision to 20/20.
•    The incumbent will be doing light to moderate lifting, carrying, or moving objects under
15-20 lbs.
•    The incumbent will be working in a laboratory setting up to eight hours per day.
•    The incumbent will be working around biohazardous materials, including chemical agents, up to eight hours per day
•    The incumbent may be exposed to fluctuating and/or extreme temperatures on occasion.
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.
 

 

 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $27.00/hr.