Roles and Responsibilities:
Testing
- Assist with routine testing and review of raw materials, stability and finished product samples and assist with Out-Of-Specifications as needed in the Quality Laboratory.
- Training
- Assess training needs for Quality Laboratory Personnel and maintain training matrices to identify progress and deficiencies.
- Build training modules to support business needs for testing raw materials, intermediates, and finished products.
- Assist laboratory management with the onboarding program for new laboratory personnel.
- Maintain a quarterly development program to train laboratory personnel in latest technological/scientific trends and instrumentation. Webinars, scientific articles, and SME presentations will support this.
- Develop Subject Matter Experts (SME's) in laboratory techniques to support training for laboratory personnel.
- Develop, implement and maintain program for Train-the-Trainer.
- Development of Quality Laboratory personnel with hands-on instrument training or live lectures.
Compliance
- Develop a competency program to periodically confirm personnel expertise and re-training needs to support laboratory accreditations such as ISO 17025.
- Assist laboratory management with re-training to support identified CAPAs as a result of laboratory investigations.
Method Transfer
- Lead technical support of transferring analytical methods to the Quality Control group.
- Mentor and train Chemists in the proper execution, including interpretation of validation studies.
- Provide support for the Calibration Program.
Support of Laboratory Systems
- Support Administration of the Empower program and Development of Superusers to support business needs in all laboratory shifts. This includes support ensuring Laboratory Data Integrity align with expectations from regulatory agencies.
- Assist maintenance of instrumentation parts/consumables system.
- Assist with the in-house instrumentation preventative maintenance (PM) program including administration of third-party services.
General
- Perform other assigned duties and follow verbal and written instructions issued by Supervisor(s) 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.
Minimum Requirements:
- Provide training support to first and second shift Quality Laboratory personnel with minimum impact to lab performance.
- Proficient in analytical methods for chromatographic, spectroscopic, titrimetric, and wet chemistry analyses.
- Proficient in Empower Software and other Laboratory software such as Tiamo used in a Quality Laboratory environment for chromatographic, spectroscopic methods as well as wet chemistry.
- Must be proficient in Laboratory instrument trouble shooting of HPLC and GC.
- Strong understanding of Laboratory instrumentation such as FTIR, HPLC, ICP, GC, UV-Vis, LC-MS, GC-MS, ICP-MS, HPTLC.
- 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 in 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.
- Able to communicate effectively and cooperatively within all levels of an organization. Strong communication skills - both verbal and written.
- Demonstrated aptitude to function in a dynamic fast-paced environment.
Education and Experience
- A Bachelor's degree in Analytical, General Chemistry, Biochemistry, Chemical Engineering, or related field is strongly preferred.
- Prior experience as a trainer or in the education field is preferred.
- 10 years of experience performing analytical methods for nutraceuticals and/or pharmaceutical testing in a GMP environment.