Key Responsibilities:

• Be familiar with standard analytical lab equipment usage in the pharmaceutical industry.
• Compile and record data for documentation needed for testing and report preparation.
• Review and update SOPs related to quality control.
• Ensure regulatory compliance by working with GLP and GMP environments.
• Interact with Operations and Quality Assurance.
• Operate and implement analytical lab instrumentation.
• Maintain and manage accurate, precise documentation.
• Support testing to comply with schedules by team-oriented processing.
• Conduct laboratory evaluation of samples.
• Record data in LIMS following standard operating methods.
• Comply with standard procedures and quality control to improve products.
• Performs chemical analysis of raw materials, in-process materials, and finished drug products in accordance with OSHA, FDA, cGMP, and other appropriate regulatory requirements.
• Collection, handling, and documentation of raw materials, chemical reagents, laboratory standards, and sample vessels (handle and move compressed gas cylinders) by OSHA, FDA, cGMP, and other appropriate regulatory requirements.
• Calibration and preventative maintenance of analytical instruments by OSHA, FDA, cGMP, and other appropriate regulatory requirements.
• Review other analysts’ work.
• Maintain standard and supply inventory levels. Organize laboratory supplies and equipment
• Perform routine housekeeping activities; create and submit HOLD alerts, deviation reports, work orders, etc.

U.S. PERSON REQUIREMENTS

Due to compliance with U.S. export control laws and regulations, the candidate must be a U.S. Person, which is defined as a U.S. citizen, a U.S. permanent resident, or have protected status in the U.S. under asylum or refugee status.