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Reference Standard Co-Ordinator

Newark Metro Area, NJ

Posted: 10/08/2019 Job Type: Scientific Job Number: JN -102019-25764


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

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.

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