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The Chemist II is responsible for performing analytical testing of raw materials, in-process samples, finished products, and stability samples to ensure compliance with quality standards and regulatory requirements. This position supports laboratory operations in a GMP-regulated environment and contributes to data integrity, continuous improvement initiatives, and overall laboratory excellence.
Responsibilities:
- Perform analytical testing using established methods, including HPLC, GC, TOC, and wet chemistry techniques.
- Independently conduct complex analytical testing with minimal supervision.
- Support method transfers, method verifications, method validations, and stability studies.
- Review and interpret analytical data to ensure accuracy and adherence to specifications.
- Troubleshoot analytical methods and laboratory instrumentation.
- Maintain accurate and compliant laboratory documentation.
- Review laboratory records and analytical results for completeness and accuracy.
- Assist with SOP revisions, method updates, and continuous improvement projects.
- Collaborate with Quality, Manufacturing, and Research & Development teams to support product quality and operational objectives.
- Support implementation of new laboratory technologies and process improvements.
- Ensure compliance with cGMP, GDP, and regulatory requirements.
- Follow data integrity principles and maintain accurate documentation practices.
- Support audit readiness activities and regulatory inspections.
- Adhere to laboratory safety policies and procedures.
- Train and mentor junior laboratory personnel on testing procedures and instrumentation.
Requirements:
- Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
- 2-5 years of Quality Control or analytical laboratory experience in a GMP-regulated environment.
- Experience with analytical instrumentation such as HPLC, GC, UV/Vis, FTIR, dissolution systems, and TOC analyzers.
- Experience with chromatography data systems, preferably Empower 3.
- Strong understanding of cGMP requirements and laboratory compliance standards.
- Experience supporting investigations involving OOS, OOT, and deviations.
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