Scientist III - Analytical Chemist - FSP

ParexelUnited States-New Jersey-Remote, NJ
Onsite

About The Position

Parexel FSP is seeking a Scientist III - Analytical Chemist to work as a full-time employee on a long-term assignment onsite at one of their clients located in Rahway, NJ. This role involves supporting cleaning verification and cleaning validation analysis for GMP manufacturing areas, conducting raw materials release testing, and preparing GMP documentation. The position requires adherence to safe laboratory practices and GMP compliance.

Requirements

  • BS in chemistry or a closely related field with at least 3-5 years of hands-on research experience
  • MS in analytical chemistry or a closely related field with at least 1-2 years of hands-on research experience
  • Hands-on experience with chromatographic analysis using various LC and GC techniques
  • General knowledge of separations science
  • Strong computer, scientific, and organizational skills
  • Excellent communication (oral and written) and attention to detail
  • Excellent organization to multi-task and manage multiple projects
  • Ability to work independently and as part of a team
  • Good understanding of GMP compliance requirements and ALCOA documentation principles

Nice To Haves

  • Experience with Empower chromatographic software and with analysis of drug formulations preferred
  • Hands-on experience with method development and validation preferred
  • Experience with raw materials release per USP/NF preferred
  • Experience with cleaning validation/verification preferred
  • Skilled in method and instrument troubleshooting, specifically for LC and GC methods and systems

Responsibilities

  • Support cleaning verification and cleaning verification swab analysis for GMP manufacturing areas
  • Conduct raw materials release testing using myriad of methodologies and techniques in a GMP laboratory
  • Support cleaning validation and cleaning verification analysis for GMP manufacturing areas
  • Data interpretation, processing, and reporting
  • Prepare GMP documentation including analytical reports and certification of analyses
  • Responsible for following safe laboratory practices and for maintaining the work area in a clean, orderly and safe manner
  • General understanding of analytical method development and method validation

Benefits

  • sick time
  • 401K
  • paid holidays
  • paid time off
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