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Title : NVG- LIMS Specialist -230
State : New Jersey   Date : May 17, 2021
Experience Level :  
Position Type : LIMS Specialist      
Description
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.

Work Location: East Hanover, NJ  

Job Title: LIMS Specialist

Duration: 6+ months (extendable) contract on W2


Duties:
  • The agreed service concerns the input of stability programs (test articles, conditions, pull points, testing regime) as well as the input of specifications for the affected products into GLIMS based on given documents (e.g. stability protocols, analytical specifications).
  • Up to know, stability protocols have been issued as pdf documents that are stored in a document management system (Subway).
  • The stability protocol describes the program of the stability study: which batches have to be tested at which timepoints with which analytical methods.
  • The task of the contractor is to access these protocols and translate the program into the GLIMS system (LIMS system from Labware). To do that it is also required to create analytical specifications for the tested products. These specifications describe the analytical methods, that need to be performed for the product, in detail (in terms of number of results to be reported, number of reported digits). The source for this information is also available in Subway in so called Analytical Specifications. The approval of both, the stability programs and the specifications will be done by internal personnel. For these activities training on the GLIMS system is required to get access.
  • To current knowledge, this affects 19 stability studies from 9 different projects. Typically (but different for each study) a stability study consists of 2 batches (for each batch one program needs to be defined in GLIMS; sometimes there are up to 4 additional conditions that are treated as separate batches), three storage conditions (intended with 8-12 pull points, accelerated with 4 pull points and stressed with 2 pull points).
Skills:
  • Junior level - 2 - 3 years of experience
  • Familiar with good documentation practice principles
  • Practical knowledge on data management and/or documentation, in regulated environment, beneficial
  • Experience on Labware LIMS beneficial – if not more time for training required
  • Helpful to know something about stability studies and analytical background
  • English fluent
Education: Bachelors degree.



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Many Thanks,   

Sree Kanth
Recruitment Manager
Sree@newageclinical.com

NewAgeSys, Inc.
Direct: 609-945-1736 Fax: 609-228-4079
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Princeton , NJ 08540 
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