Job Description

Location (mandatory): Pearl River, NY 10965 (On-site) Quality Control Chemist supports a GMP-regulated Quality Control laboratory environment focused on pharmaceutical and biopharmaceutical products. This role involves performing routine analytical testing, documenting results in electronic systems, and supporting the release and stability testing of highly regulated products. The successful candidate will work in a collaborative team environment while maintaining compliance with cGMP requirements and established laboratory procedures.

• 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.

• 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

• 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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