Roles and Responsibilities:
- Validation of analytical methods to ensure analysis and prompt release of raw materials, finished products, and stability studies.
- Design and execute method transfer protocols of analytical methods oriented to the timely manner release of product by the QC department.
- Proficient in Empower Software and other laboratory software use in QC environment for chromatographic, spectroscopic methods as well as wet chemistry.
- Aides in the timely preparation, review and approval of technical documentation.
- Assess testing methodologies and their application to different sample matrix and will include evaluation of testing results from contract laboratories to be sure that the agreed methods and testing parameters were properly followed.
- Maintains current knowledge of latest technological and scientific trends and serves as an analytical science resource for the rest of the group. Mentor and train chemists in the proper execution, including interpretation of validation studies.
- Assist with routine testing of raw materials, stability samples finished products and out of specifications as needed in Quality Control.
- Perform other assigned duties and follow verbal and written instructions issued by supervisor or designee related to meeting company goals and objectives.
- Communicate effectively with other departments within the organization and function within a team environment.
- Regular attendance is required.
- Must be proficient on laboratory instrument trouble shooting.
- Proficient in most of the laboratory instrumentation such as FTIR, HPLC, ICP, GC, UV-Vis, LC-MS, GC-MS, ICP-MS, HPTLC and test methods.
- Knowledge of statistical techniques, such as data trend analysis and design of experiments, is highly desirable. Proficiency in reviewing and interpretation of laboratory data.
- Detailed knowledge of principles of routine laboratory operations.
- Thorough working knowledge of industry regulations, FDA and ICH guidelines; experience implementing and maintaining adherence to pharmaceutical and/or nutritional supplement GLP/GMP is strongly desired.
- Demonstrated aptitude to function in a dynamic fast-paced environment.
Education and Experience
- A Bachelor’s degree with 7 years of experience in validation of analytical methods for nutraceuticals and/or pharmaceutical samples in a GMP environment. A Master’s degree and a minimum of 3 years of technical experience is preferred. Extensive experience may be accepted in lieu of an advanced degree.
- A degree in analytical chemistry, biochemistry, chemical engineering or related fields is strongly preferred.
- A need to work on the bench to accomplish tasks along with the Analytical Chemistry team
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