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Analytical Chemistry Data Review Associate

Location: Durham, NC, United States
Job # 9907078
Date Posted: 09-11-2017
Analytical Chemistry Data Review Associate
Durham, NC 27703

Pay Rate: $22-$25/hour (DOE)
Start: ASAP
Contract to Hire

Our client is a growing, dynamic Fortune 100 company focused on developing inhalation combination therapies for the treatment of highly prevalent chronic respiratory diseases, including chronic obstructive pulmonary disease (COPD) and asthma.  We are seeking to hire individuals that bring energy and passion to deliver the medicines that provide patients and healthcare provider’s therapies to achieve better clinical outcomes. 

Duties and Responsibilities:
  • Peer review of R&D laboratory documentation and data to appropriate standards including: protocols, SOP's, methods, and specifications.
  • Peer review of results and documentation of product development studies including statistical data reports (JMP)
  • Peer review of HPLC chromatography  and associated documentation
  • Six or more years GMP pharmaceuticals laboratory experience
  • Experience testing inhalation products preferred, especially MDls. with a variety of active pharmaceutical ingredients at different stages of development.
  • Three or more years of HPLC experience in a GMP/QC setting. ChemStation software preferred.
  • BS. MS, or PhD  m Chemistry, Pharmaceutical Sciences or a similar applicable discipline.
  • In-depth knowledge  m at least one of the following areas: analytical instrumentation, MDI
    performance methods, assay and related substances methods, or instrument qualification.
  • Experience  with controlled  documents. documents for regulatory submissions and knowledge of
    GMP requirements  is desired
  • In-depth understanding of relevant ICH. USP, EP, and FDA guidance documents as well as cGXPs in support of MDI product testing is desired
  • Must be able to effectively communicate verbally and through writing
  • Must be willing to shave facial hair for respirator use as part of lab responsibilities as needed.
If qualified, please respond back with a resume saved as word document to be considered.
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