14 days ago
The Quality Control Chemist, Finished Product reports to the Finished Product Group Leader. The primary purpose of the job is to perform testing and make calculated decisions on the acceptability of process validation samples, raw materials, finished products, stability samples, and developmental samples in a regulated laboratory environment in support of timely disposition of manufactured products. Analyze and interpret results in written and oral format. This is a contract assignment lasting up to 6 months.
- The primary responsibility is to perform routine release tests of raw materials and finished products including wet chemistry analysis, dissolution, content uniformity, assay, particle size distribution, density, water determination by KF, and other tests according to the in-house specifications and methods and USP monographs using classical wet chemistry and instrumental techniques.
- Perform routine tests like assays, related compounds, chromatographic purity, residual solvents, particle size distribution, Infra-red spectroscopy using different techniques and instrumentation like UV, HPLC, GC, IR etc.
- Operate Empower software with custom calculations
- Evaluates test results and decides acceptability of the samples based on the test results. Reviewing and releasing of the raw data, documentation and results for certificate of analysis.
- Write draft technical documents like specifications, analytical methods, method verification protocols and reports, method transfer documents, investigation reports etc.
- Maintain accurate lab notebooks and complete all related analytical reports, write summaries, and keep proper documentation in compliance with SOPs.
- Follow SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices. Maintain the laboratories with good housekeeping practices and in compliant with cGMP.
- Other duties related to departmental activities may be assigned by management based on situation and necessity
- Bachelor’s Degree in Chemistry or related scientific field and 3+ years’ industry experience as a Chemist
- Master’s Degree in Chemistry or related scientific field and 1+ years’ industry experience as a Chemist
- Knowledge of current GMP guidance, applicable USFDA and ICH guidelines and regulatory requirements (such as USP/ICH requirements)
- Ability to make observations with instruments and analysis techniques
- Basic knowledge of instrument techniques like HPLC (Waters, Dionex), GC, IR, KF, metrohm titrator, etc. and software for instruments like Empower, Chromeleon etc.
- Ability to carry out necessary computations and to draw and interpret graphs.
- Basic knowledge of method validation, method transfer and method verification of the analytical methods.
- Basic to advanced level of computer skills.