Chemist A
2 months ago
Dayton, New Jersey, United States
Aurobindo Pharma USA
Full time
Job OverviewThe R&D Chemist A will play a crucial role in the development and validation of analytical methods for incoming raw materials and finished products. This position requires a strong understanding of Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs) to ensure compliance with regulatory requirements.
Key Responsibilities- Method Development and Validation: Actively involved in the development and validation of analytical methods for raw materials and finished products.
- Testing and Analysis: Perform testing and analysis of raw materials, in-process materials, and finished products to ensure quality and purity.
- Documentation and Record-Keeping: Prepare and review documents such as SOPs, test procedures, and specifications for raw materials and finished products.
- Equipment Operation and Maintenance: Operate and maintain general analytical instruments, including HPLC, UPLC, GC, UV/Vis, and IR spectroscopy.
- Quality Control and Assurance: Perform quality control and assurance activities to ensure compliance with regulatory requirements.
- Collaboration and Communication: Collaborate with cross-functional teams, including formulation, quality control, and regulatory affairs, to ensure seamless execution of projects.
- Education: Minimum BS/MS in a scientific field.
- Experience: Minimum 1-3 years of experience in pharmaceutical R&D and 2-4 years in QC setting.
- Skills: Strong analytical and problem-solving skills, ability to learn quickly, and decision-making skills.
- Regulatory Knowledge: Knowledge of USP, ICH, FDA, and DEA regulations.
The Chemist A must be able to bend at the waist and knees, twist at the trunk, and lift up to 25 lbs. The position requires working in the laboratory and sitting for extended periods. The Chemist A must also be able to wear laboratory protective gowning and equipment, including goggles, face shields, respirators, and protective gloves.