Scientist III

Quality Control Chemistry is responsible for qualification of equipment, software and authoring the documents including qualification, SOP etc. The candidate will perform bioassays, analytical testing, rheology evaluations, and statistical data analysis to ensure product quality, safety, and compliance with regulatory standards. Experience with Hamilton systems, statistical software, and rheology, CCIT, FT-IR instrumentation is preferred. Additional functions include method validation/verification, tech transfers etc. in the Quality Control laboratory. Description Perform routine and non-routine bioassay testing for raw materials, in-process samples, stability samples, and finished products. Operate and maintain Hamilton Microlab Star automated liquid handling systems for bioassay preparation and sample processing. Familiar with BioStat, PLA, SoftMax Pro etc. statistical software for Hamilton bioassay testing. Conduct qualification activities for laboratory instrumentation including but not limited to Hamilton, Rheometers, FT-IR, CCIT, UV Spectrophotometer etc. Prepare technical reports, SOPs, protocols for qualification of instruments and investigation documentation in compliance with cGMP, FDA, and ICH guidelines. Support method qualification, validation, and transfer activities. Perform instrument calibration, troubleshooting, maintenance, and documentation. Work effectively with others to achieve shared goals and perform weekly trending meetings for qualification/upgradation activities. Interact with external vendors on technical matters requiring coordination for qualification activities. Work independently with minimal supervision and direction in compliance with cGMPs. Practice safe work habits and adhere to ThermoFisher's safety procedures and guidelines. HSE It is required that individuals care for their own safety and wellbeing. Individuals must promote a safe working environment for employees and contractors working in their area of responsibility. The individual must support site HSE policies as well as ensure that work performed is compliant with local HSE regulations. Individuals must complete all required HSE trainings. Everyone is required to report all accidents and incidents and support investigations in their areas of responsibility. Individuals must ensure timely closure of HSE actions owned by their departments. Requirements Basic Qualifications Bachelor's Degree in Life Sciences discipline and 6-8 years' experience in cGMP lab environment, or a Master's Degree in Life Sciences discipline and 5 years' experience in cGMP lab environment. Proficient in Outlook and Microsoft Word and Excel and lab-based data management systems. Scientific technical writing ability. Preferred Qualifications Hands-on experience with BioAssay (Hamilton Microlab Star) with BioStat, PLA or SoftMax Pro software. Rheometers, FT-IR, UV Vis Spectroscopy and CCIT. Experience with instrument and software Qualification. Knowledge of lab-based data management systems. Familiarity with FDA and USP global compendia requirements. #J-18808-Ljbffr Merck & Co.