Christopher Smith Email & Phone Number

Grand Island, NY

Grand Island, New York

Responsible for Quality System continuous improvement project and system enhancements.

2437 William St. Cheektowaga, NY

Bar & Restaurant

Grand Island, New York

• In charge of cGMP Compliance for multiple Quality Assurance Systems, including Complaint & Deviation Management, Document Control, and Annual Product Review.
• Manage the Customer Complaint and Deviation Systems through nine investigators, ensuring the timely completion of quality stand alone investigations.
• Authored and executed a complete content overhaul of the Annual Product Quality Review, ensuring compliance to FDA, Q10, and EMEA standards.
• Author, transmit and… Show more In charge of cGMP Compliance for multiple Quality Assurance Systems, including Complaint & Deviation Management, Document Control, and Annual Product Review.
• Author, transmit and track required FDA correspondence (i.e., audit observations, field alerts, recalls).
• Manage all cGMP Documentation, including document retention and archiving, ensuring FDA Compliance.

Grand Island, New York

Managed Aseptic filling department on 2nd shift, including Vial/Stopper Preparation, Sterilization, Filling/Capping, Inspection, Packaging, and Warehouse activities.Authored and executed a waste reduction and departmental continuous improvement plan in line with lean manufacturing principles.Responsible for all aspects of the 2nd shift operation, including.