Job Details

  • Title: Quality Control Analyst
  • Code: RCI-CELG-8602
  • Location: Summit New Jersey (NJ) 07901
  • Posted Date: 10/08/2019
  • Duration: 12 Months

  Job Description

Seeking a candidate to handle the daily operation of Development and commercial reference standard program for Stability Group within Analytical Development function at client’s site.

 

Responsibilities include:

 

  • Coordinates with Analytical Project Leader to ensure timely qualification and requalification of Reference Standards or Reference Materials.
  • Responsible for proper storage and inventory control of Reference Standards or Reference Materials in the designated secure area.
  • Purchases, stores, and handles Reference Standards from compendia sources for routine use according to compendia instruction under the supervision of the Analytical Project Leader.
  • Maintains inventory and list of Reference Standards and Materials.
  • Distributes Reference Standards and Reference Materials to users, such as Laboratory Analysts and contract service providers.
  • Sends notifications to Analytical Project Leader when the inventory is low.
  • Disposes of remaining quantity of Reference Standards or Reference Materials from the designated secure area when the requalification is discontinued.
  • Prepares Purity Statement based on qualification/ requalification data.
  • Will report to Director Analytical Development.

 

Skills/Knowledge Required:

 

  • BS/MS Chemistry (Organic or Analytical) or relevant discipline with equivalent experience.
  • Manager open to Ph.D. Chemistry candidates.
  • Should have knowledge in the analytical testing required to generate reference standard purity statements
  • Minimum 2 - 4 years recent cGMP/GLP pharmaceutical laboratory experience.
  • Prior reference standard handling experience required.
  • Good communication skills.
  • Able to work well in team environment to achieve results.
  • Exhibits sound scientific judgment based on reasonable assumptions and available information.
  • This position required on-site presence, Mon-Fri.