Location: Lancaster, SC
The position of Quantitative Researcher in Lancaster, SC requires a highly skilled Analytical Scientist who can independently validate new analytical methods and provide technical support to various corporate groups including Quality Control, Quality Assurance, and International Business.
This role will have the following responsibilities:
- Validate analytical methods to ensure the timely analysis and release of raw materials, finished products, and stability studies.
- Develop and execute protocols for transferring analytical methods to the QC department for product release.
- Proficiency in the use of Empower Software and other laboratory software for chromatographic, spectroscopic methods, and wet chemistry in a QC environment.
- Assist in the preparation, review, and approval of technical documentation in a timely manner.
- Evaluate testing methodologies and their applicability to different sample matrices, including the review of testing results from contract laboratories to ensure compliance with agreed methods and parameters.
- Stay updated with the latest technology and scientific trends and serve as a resource for the analytical science team. Mentor and train chemists in the proper execution and interpretation of validation studies.
- Conduct routine testing of raw materials, stability samples, finished products, and out-of-specification samples as required for Quality Control.
- Perform other assigned duties and follow instructions issued by the supervisor or designee to achieve company goals and objectives.
- Demonstrate effective communication with other departments within the organization and work well in a team environment.
- Regular attendance is mandatory.
The minimum requirements for this position are:
- Proficiency in troubleshooting laboratory instruments.
- Expertise in a wide range of laboratory instrumentation such as FTIR, HPLC, ICP, GC, UV-Vis, LC-MS, GC-MS, ICP-MS, HPTLC, and various test methods.
- Knowledge of statistical techniques, data trend analysis, and design of experiments is highly desirable. Proficiency in reviewing and interpreting laboratory data.
- Detailed understanding of routine laboratory operations.
- Thorough working knowledge of industry regulations, FDA and ICH guidelines, and experience in implementing and maintaining adherence to GLP/GMP in the pharmaceutical and/or nutritional supplement industry.
- Demonstrated ability to work in a dynamic, fast-paced environment.
Education and Experience:
- Bachelor's degree with 7 years of experience in the 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 are preferred. Extensive experience may be considered in lieu of an advanced degree.
- Preferably a degree in analytical chemistry, biochemistry, chemical engineering, or related fields.
- Required to work hands-on with the Analytical Chemistry team to accomplish tasks.