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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