Job Details

  • Title: QC Associate Scientist
  • Code: RCI-8847
  • Location: Summit New Jersey (NJ) 07901
  • Posted Date: 12/02/2019
  • Duration: 10 Months
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  Job Description

Description:

1. Purpose and Scope of Position

Under supervision, the QC Associate Scientist is responsible for supporting the testing and release of incoming materials used in CAR-T manufacturing during clinical and commercial phases. Additionally, when needed, provide support with the authoring of technical documentations.

2. Required Competencies: Knowledge, Skills, and Abilities

  • Ability to follow and apply Global Regulatory and cGMP requirements
  • Ability to author technical documents using clients QC templates
  • Knowledge of analytical techniques such as HPLC, GC, FTIR, Osmolarity and pH, hands-on experience preferred
  • Ability to meet timelines in all assigned projects and acclimate to changing priorities
  • Ability to follow, review and revise SOPs
  • Ability to work in a collaborative team environment
  • Ability to recognize and communicate simple and complex problems with relevant team member, department management and cross-functional peers
3. Duties and Responsibilities

  • Perform and document release testing of incoming materials
  • Sampling of test materials and retain samples based on sampling plans
  • Perform visual inspections in warehouse settings with different temperature zonings
  • Manage shipment of samples for tests performed at contract testing laboratories
  • Assist management with investigations and deviations
  • Collaborate with teams to identify and implement process improvements
  • Complete all work in a timely manner.
Assist document revision, project, CAPA, and investigation/deviation tasks.
  • Assist in drafting technical documents, such as SOPs and protocols/reports
  • Communicate effectively with management regarding task completion, roadblocks, and needs
  • Proactively and contribute to the continuous improvement throughout investigation/corrective action lifecycles
  • Performs other tasks as assigned
4. Education and Experience
  • Bachelor’s Degree required, preferably in Science
  • 2+ years of relevant work experience, preferably in a regulated environment
  • An equivalent combination of education and experience may substitute.
5. Working Conditions
  • The incumbent should be able to distinguish colors and possess correctable vision to 20/20, annual eye exam is required
  • The incumbent must analyze numerical values on a daily basis
  • The incumbent will be working a laboratory setting up to six (6) hours per day
  • The incumbent will be working around biohazardous materials, including chemical agents up to six (6) hours per day
  • The incumbent will be doing light to moderate lifting of objects under 15-20lbs