Job Details

  • Title: QC Sample Management Technician
  • Code: RCI-8980
  • Location: Warren New Jersey (NJ) 07059
  • Posted Date: 01/14/2020
  • Duration: 12 Months
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  Job Description

The primary responsibility of this position is to support QC sample management and QC incoming material for Developmental Quality Control Operation Department. The scope includes daily processes associated with sample or material receipt, movement, storage, inventory, distribution, documentation and shipments within the cGMP operation for CTDO Developmental QC for CAR T.

Responsibilities will include but are not limited to the following:

  • Ensures the chain of custody of QC samples are maintained throughout the complete life span of samples: Receipt, handling, storage and destruction of QC samples at the site.
  • Responsible for sampling QC incoming materials in collaboration with warehouse personnel and CAR T QC incoming material team.
  • Organizes shipment of samples to external laboratories.
  • Supports on-site execution of the stability program samples per study protocol by ensuring stability samples are properly placed on stability time points with correct storage condition.
  • Management of parallel samples, reference and retention samples at the site.
  • Create and revise SOP, FORM, WP, and TRN related to sample management.
  • Provide range of support of QC services such as ordering and receipt of lab supplies.
  • Establish and maintain Inventory of QC incoming material, QC Material retain, QC samples and QC Regulatory retains.
  • Initiates and investigates CAPA and Deviations as applicable.
  • Develop understanding and assembly of weekly process schedule assignment for drug product samples and incoming QC materials.
  • Assist in analytical sample trouble shooting and investigations as needed.
  • Demonstrate general understanding of root cause analysis and CAPA methodologies.
  • Assist with preparation and execution of equipment installations related to sample management.
  • Perform other tasks as assigned.
Skills/Knowledge Required:
  • Bachelor Degree with 0-2 yrs of relevant work experience required, preferably in a regulated industry.
  • Sample management experience is a PLUS.
  • Ability to work collaboratively and cross-functionally with peers.
  • Strong communication skills (oral and written). Proficient with computer software programs/ applications and capable of preparing technical reports as required.
  • Demonstrate an initiative for advancement within department/organization
  • Ability to conduct training for new employees within the group.
  • Strong attention to detail.
  • Ability to work independently for extended periods of time with minimal supervision.
  • Ability to follow and understand detailed instructions accurately.
  • Ability to work with cold chain room, or don sterile gowning during sample transfer.
  • Ability to periodically lift up to 50lbs when required in support of sample transfer, cleaning activities and equipment set up.
Desired:
  • 1+ years in a Quality Control laboratory or sample management experience.
  • 1+ years of device, Biologics, or relevant industrial experience
  • Proficient in Microsoft Word/Excel/Access