Roles and Responsibilities:
- Analytical Development Specialist reports to Analytical Development Management.
- Receive, submit and coordinate client requests for testing, review and generation of summary report/COA's for special request samples for both Maryland and South Carolina.
- Manage sample inventory, disposal of samples, contract lab testing as needed and follow up with contract lab results to ensure timely completion of the project.
- Coordinate meetings and maintains open communication between Innovation Team, Quality Control and Quality Assurance as needed. This will include the schedule of meetings, preparation of meeting agendas, meeting notes and minutes, including action items.
- Track area performance through measurable metrics and developing process improvements to improve response times and service quality.
- Keep track of the status of special request sample testing, coordinates necessary testing and review with the Quality Control Management.
- This position will work closely with the Stability Coordinator on the performance of new formulations on stability.
- Aid in the timely preparation, review and approval of technical documentation such as specifications and label claims.
- 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.
- Maintain current knowledge of latest technological and scientific trends and serves as an analytical science resource for the rest of the group and will include interpretation of the results.
- Assist with routine testing and review to ensure prompt completion of the special request samples.
- Communicate effectively with other departments within the organization and function within a team environment.
- Regular attendance is required.
- Perform other assigned duties to meet company goals and objectives.
Summary of the Position: The Analytical Development Specialist will provide project management for ongoing special request sample program with Product Development Team. This position will be responsible for daily customer communication and contact internal and external Analytical Development customers to ensure timely/accurate completion of the projects. Serves as project manager for clients' samples, keeping clients informed of status and TAT and lab informed of client requirements.
- Knowledge in Empower Software, other laboratory software's and laboratory instrumentation use in QC environment for chromatographic, spectroscopic methods as well as wet chemistry preferred. Including experience with operation of laboratory instrumentation such as HPLC, GC, FT-IR, LC-MS, ICP-MS and others.
- 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, Pharmacopeia's and ICH guidelines; experience implementing and maintaining adherence to pharmaceutical and/or nutritional supplement GLP/GMP is strongly desired.
- Knowledge in Stability Program
- Must able to function in a dynamic fast-paced environment.
- Excellent customer service skills, attention to detail, and ability to be persistent while maintaining tact.
Education and Experience
- A Bachelor's degree in Science with 5 years of experience in nutraceuticals and/or pharmaceutical environment or equivalent.
- The qualified candidate should possess experience in quality control or research and development. Must have strong understanding of experimental design, chemical theory and analytical instrumentation.