Associate Specialist, Quality Control - Temp to Perm
Morristown, NJ Quality
Job Type
Temporary
Description


About Celularity

Celularity Inc., headquartered in Florham Park, N.J., is a biotechnology company leading the next evolution in cellular medicine by developing off-the-shelf placental-derived allogeneic cell therapies for the treatment of cancer and immune and infectious diseases. Celularity is developing a pipeline of off-the-shelf placental-derived allogeneic cell therapy product candidates including T cells engineered with a chimeric antigen receptor ("CAR"), natural killer ("NK") cells, and mesenchymal-like adherent stromal cells ("MLASCs") and exosomes. These therapeutic candidates target indications across cancer, infectious, and degenerative diseases. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it will be able to develop therapeutic solutions that address a significant unmet global need for effective, accessible, and affordable therapeutics.


Summary

The entry level Assoc. Specialist, QC - Temp to Perm role is responsible for supporting biobanking/ manufacturing requests.  This includes the ability to interface with multiple groups, independently perform tasks, interpret results, and generate reports.  

  

Required Competencies: Knowledge, Skills, and Abilities

  • Ability to understand the cGMP environment, follow the procedure and requirements for internal and external testing sample handling, prepare technical documents, and apply good laboratory practices.
  • Ability to coordinate with external organizations for sample and data status tracking.
  • Problem-solving ability/mentality; technically adept and logical.
  • Ability to communicate effectively with peers, department management, and cross-functional peers. 

Duties and Responsibilities


Will Perform testing 

  • Visually inspect products for particulates and use appropriate equipment 
  • Complete all work on time and be able to work independently.
  • Support raw material, in-process, final product, and stability testing when needed.
  • Support schedule for shipment preparation.
  • Support other lab work, such as Flow and viability determination, etc., and prepare final samples within a specified timeline.

Track sample status concerning receiving, pending testing, and data acquisition.

  • Maintain contact with internal and external organizations for status updates via email, phone, etc.
  • Provide regular status updates to supervisor and team as appropriate.

Participate in the processing of maternal blood samples received from various donors.

  • Prepare maternal blood components for storage and shipping to outside vendors. 
  • Communicate with external testing labs as appropriate.
  • Review Transfusion-Transmissible Disease results and file reports in compliance with effective SOPs and the regulations they align with.
  • Comply with HIPAA, OSHA, FDA, and other regulatory agency conduct requirements. 

Perform peer review of testing data and create Certificates of Analysis.

  • Review all data following applicable procedures and cGMP requirements.
  • Complete all reviews following required release timelines.
  • Communicate effectively with peers and demonstrate teamwork regarding obtaining results, completing reviews, and requesting corrections required.

Performs other tasks as assigned.

Requirements

Education and Experience

  • Bachelor's degree in a scientific discipline is preferred.
  • 0 – 3 years of relevant work experience, preferably a recent graduate.
  • An equivalent combination of education and experience may substitute.
  • Experience working in a clean room environment.

Working Conditions

  • The incumbent will analyze numerical values and handle samples daily.
  • The incumbent will work in a laboratory setting for up to seven (7) hours daily.
  • Flexible scheduling required: Mon – Fri or, if needed, Tues – Sat schedule.
  • Some light lifting may be required occasionally

This job description describes the general nature and level of work the person assigned performs. The primary duties and responsibilities represent those functions essential to this job's performance.


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


Must be authorized to work directly for Celularity in the U.S.


No agency submittals accepted  


Celularity is an Equal Opportunity Employer