Andrew Maisel Email & Phone Number

Bothell, Washington, United States

Spokane, Washington, United States

Portland, Oregon Area

* Coordinate the New Product Implementation process between multiple departments.* Draft and revise SOPs and SSOPs to maintain compliance with regulatory standards.* Interface with customers in order to supply them with their documentation requirements as regulated by GFSI and FSMA.* Currently working as a project coordinator for a Microsoft Dynamics NAV.

Portland, Oregon Area

• Reviewed Certificates of Analysis for correctness, and compared with specifications.
• Coordinated with vendors to resolve questions or errors on specifications or C of As.
• Operated laboratory equipment: LOD, pH, IR Thermometer, Digital Salt Meter, and Brix Meter.
• Trained others on the operation of laboratory equipment.
• Sample receipt and chain of custody recording for all laboratory samples.
• Monitored and maintained inventory for laboratory supplies.

Managed NPI process from proof of concept to initial launch batch production. Planned timeline for New Product Introduction, and coordinated activities with multiple departments. Entered and maintained product information in Microsoft Dynamics ERP system. Drafted product specifications, and Master Manufacturing Records for new products.

Managed Change Control process for changes to existing products, processes, and equipment. Managed entry of new products into MAS90 ERP system. Worked on implementation team for ETQ Quality Management Software.

Sandpoint, ID

• Logging, routing and tracking all requested documentation changes and revisions.
• Maintenance of all controlled documents within the quality system.
• Tracking and implementation of periodic review of controlled documents within the quality system.
• Coordinating all requested changes and revisions submitted during the review process. Included formatting and coordination with cross functional departments to assure all documents were maintained within a controlled.

Sandpoint, ID

• Drafting and executing installation and operational qualifications for new and existing equipment.
• Responsible for assistance in the execution of performance qualifications and process validations.
• Coordination of approval of validation protocols.
• Performed in process, and finished good quality inspections as part of execution of qualifications using a variety of inspection equipment.

Sandpoint, ID

• Performed internal quality audits for FDA and ISO 9001 compliance.
• Back-up for production shift supervisor, including shift supervision.
• Responsible for operation of production equipment.
• Responsible for in-process quality inspections and producing acceptable product.
• Responsible for accurately completing batch documentation.

Sandpoint, I

• Supervision and leadership of on shift production operators.
• Responsible for coordination of production schedule and assignment of production tasks.
• Performed internal quality audits for ISO 9001 compliance.

Sandpoint, ID

• Responsible for shipment of all production items via Common and Truck carriers.
• Trained in and responsible for all Hazardous material shipments.
• Responsible for receipt and initial inspection of all received components and materials.
• Performed internal quality audits for ISO 9001 compliance.