QC Analytical Chemist - III Job at SGS Consulting, New York, NY

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  • SGS Consulting
  • New York, NY

Job Description

Job Responsibilities:

  • Perform laboratory testing of: Raw materials Drug substances Drug products In-process samples Stability samples
  • Raw materials
  • Drug substances
  • Drug products
  • In-process samples
  • Stability samples
  • Conduct routine wet chemistry and analytical testing using laboratory instrumentation, including: HPLC GC UV-Visible Spectroscopy CGE ICE Polarimeter Osmometer pH Meter Conductivity Meter TOC Analyzer
  • HPLC
  • GC
  • UV-Visible Spectroscopy
  • CGE
  • ICE
  • Polarimeter
  • Osmometer
  • pH Meter
  • Conductivity Meter
  • TOC Analyzer
  • Accurately document and review analytical results using electronic laboratory systems (LIMS).
  • Follow all cGMP requirements, laboratory procedures, SOPs, and regulatory guidelines.
  • Participate in peer review of data and laboratory documentation.
  • Maintain laboratory equipment and ensure testing is performed according to approved methods.
  • Support internal and external audits by maintaining thorough and compliant documentation.
  • Complete required training in laboratory operations, safety procedures, and quality systems.
  • Strictly adhere to safety procedures while working with high-potency oncology products.
  • Use personal protective equipment (PPE) and respiratory protection when required.
  • Comply with OSHA and site-specific safety requirements.
  • Work in a laboratory-based, electronic paperless documentation environment utilizing LIMS.
  • Collaborate with quality, compliance, and laboratory personnel.

Skills:

  • GMP/cGMP
  • Quality Control
  • Analytical Testing
  • Wet Chemistry
  • HPLC
  • GC
  • UV-Visible Spectroscopy
  • CGE
  • ICE
  • Polarimeter
  • Osmometer
  • pH Meter
  • Conductivity Meter
  • TOC Analyzer
  • LIMS
  • Empower Chromatography Software
  • Documentation
  • SOPs
  • Regulatory Compliance
  • Data Management
  • Audit Support
  • Electronic Laboratory Systems
  • Pharmaceutical Industry
  • Biopharmaceutical Industry
  • PPE
  • OSHA
  • Attention to Detail

Education/Experience:

  • Bachelor's or Master's degree in: Chemistry Biochemistry Pharmaceutical Sciences Related scientific discipline
  • Chemistry
  • Biochemistry
  • Pharmaceutical Sciences
  • Related scientific discipline
  • Minimum 5 years of experience in a GMP/cGMP Quality Control laboratory environment.
  • Experience within the pharmaceutical or biopharmaceutical industry is required.
  • Hands-on experience with analytical instrumentation such as HPLC, GC, and UV.
  • Strong understanding of GMP documentation practices and regulatory compliance.
  • Experience working with electronic laboratory systems and data management tools.
  • Ability to follow detailed procedures and maintain a high level of accuracy.
  • 5–7 years of pharmaceutical QC laboratory experience.
  • Experience using Empower chromatography software.
  • Previous involvement in audit-ready environments.
  • Experience reviewing laboratory documentation and SOPs.

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