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.• Package, label, and ship filled product to meet market needs.• Maintain logbooks and documentation of all activities according to company SOP and cGMP guidelines.

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