Reference Standard Co-Ordinator
Newark Metro Area, NJ
Seeking a candidate to handle the daily operation of Development and commercial reference standard program for Stability Group within Analytical Development function.
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.
BS/MS Chemistry (Organic or Analytical) or relevant discipline with equivalent experience.
Minimum 2 - 4 years recent cGMP/GLP pharmaceutical laboratory experience.
Prior reference standard handling experience is highly desired.
Good communication skills.
Able to work well in team environment to achieve results.
Exhibits sound scientific judgment based on reasonable assumptions and available information.