Evan-Michael Weber Email & Phone Number

Largo, Florida, United States

• Write and review standard operating procedures and batch manufacturing records in compliance with cGMP regulations.
• Operate robotic antiseptic fill machines for the purpose of sterile injectable medication manufacture under ISO 8 and ISO 5 conditions.
• Perform process, equipment, and documentation validation through IQ, OQ, and PQ methods.
• Dispense and mix active pharmaceutical ingredients under ISO 8 and ISO 5 conditions.
• Perform experimental design to determine critical process parameters to produce consistent quality drug product in accordance with cGMP regulations.
• Collaborate with research and development team to optimize process parameters of commercial processes.

Largo, Florida, United States

• Worked alongside production department to ensure sterility of pharmaceutical products for injection in accordance with cGMP regulations.
• Performed environmental monitoring of clean room environments to ensure proper ISO 8 and ISO 5 environments.
• Performed routine testing of water for injection through membrane filtration to determine the presence and quantity of microorganisms.
• Performed growth promotion and inhibition testing on various agar and media to ensure their efficacy.
• Prepared and reviewed corrective and preventative action plans (CAPAs) for out of limit test results.
• Documented results and performance of tests in appropriate documentation and logbooks according to company SOP and cGMP guidelines.

Bachelor Of Arts - Ba, Psychology, 3.65 Gpa

Bachelor Of Science - Bs, Biomedical Sciences, 3.65 Gpa