08 set - Monza
Thermo Fisher Scientific
Work Schedule
7 1/2 hr shift
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Laboratory Setting, Will work with hazardous/toxic materials
At Thermo Fisher Scientific, you'll begin exciting work and join a team that values performance, quality, and innovation. We encourage you to excel as an integral part of our successful global organization. With revenues exceeding $35 billion and the industry's largest R&D; investment, we provide our employees with the resources and chances to create meaningful contributions.
Monza offers coordination with controlled drug regulations in Europe and the U.S. as well as disposable manufacturing technologies and fully coordinated secondary packaging services and has received regulatory approval from various international regulatory inspection agencies, including: ANVISA, JP PMDA, US FDA, EMA, GCC States, Canada, Russia, Taiwan, Turkey. The Monza site currently supplies over 20 countries - all the major international markets,
including the U.S., Europe, and Asia Pacific.
Responsibilities
- Perform sophisticated laboratory activities using analytical tools such as HPLC, GC, IR, UV-Spectrophotometer, supporting product development efforts and stability testing.
- Conduct testing of raw materials, in-process & finished products, formulations according to SOPs.
- Develop, transfer, and validate analytical methods, and compile data for documentation.
- Ensure all testing processes and documentation meet SOPs and cGMP standards.
- Provide support with autonomy in the review of simpler analyses performed by other analysts.
- Maintain equipment and materials in good condition and handle waste according to company procedures.
Requirements:
- Bachelor’s degree in chemical pharmaceutical, biology, chemistry, biotechnology, or a related field, or equivalent work experience and knowledge.
- Proficiency with MS Office suite.
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