Michael Zotto

⦁ Execute rigorous gowning procedures to enter sterile environments daily.
⦁Use Aseptic Technique for viable environmental monitoring methods ranging from passive, and active air sampling via settle plates and portable SAS units to direct contact plating of both equipment and personnel, and nonviable samples with portable Lasair III units.
⦁Taking a lead role in implementation of LIMS software. And have trained several team members on how to progress samples through their lifecycles.
⦁Write investigations for deviations in procedure alongside QA, and use collected data to determine root causes and possible product impact.
⦁Use Facility Cameras to routinely audit aseptic technique of personnel in Grade A and B areas, and perform video reviews of any deviations from procedure.
⦁ Consolidate, aseptically transfer, and read thousands of viable samples after every shift to ensure data integrity.

• Responsible for execution of manual and automated Fill Finish operations from washing, preparing and wrapping parts for fill machines, to inspecting filled syringes for any defects.
• Demonstrated aseptic technique in front of management regularly, and intervention qualified to assist with any problems during routine product fills.
• Managed and troubleshot equipment such as autoclaves, parts washers, packaging serialization machines etc.
• Guaranteed work area is sanitized to highest standards available and assisted with CAPA whenever necessary.
• Rigorously followed and offered critique on SOPs and implemented curriculum training sheet for department

• Organized work to meet demanding production goals.
• Inspected products and machines to maintain quality and efficiency.
• Examined incoming materials and compared to documentation for accuracy and quality.
• Have processed and taken hundreds of samples for QC Micro, Chemistry, and Validation for testing
• Compliant with all SOPs, cGMPs and GDPs and always show up to work properly gowned

• Answered incoming phone calls and addressed questions from customers and healthcare providers.
• Worked alongside pharmacists using QS1 software to ensure that medications are dispensed both safely and efficiently
• Counted and labeled prescriptions with correct item and quantity.
• Stocked, labeled and inventoried medication to keep accurate records.