QC Analytical Chemist - III
SGS Consulting
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.
Vacancy posted a month ago
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