James Cramer Email & Phone Number

Cambridge, Ma, Us

Cambridge, Massachusetts, United States

Cambridge, Massachusetts, United States

Cambridge, Massachusetts, United States

Lexington, Massachusetts

Somerville, Massachusetts

Somerville Ma

• Manage movement of bulk shipments between internal and external partners including coordination of activities and preparation of supporting documentation/invoices.• Represent Clinical Drug Supply (CDS) on shipment related matters to ensure timely delivery of drug substance and finished goods to internal, external sites, and vendors.• Raise clinical order issues to management and key customers (Clinical Planning, External Manufacturing, and QA) and propose mitigation strategies on a routine basis.• Responsible for initiating deviations and CAPA implementation in a timely compliant manner.• Work globally with Clinical Logistics as well as cross functionally with peers in supporting departments (label and packaging and materials management) to maintain consistent practices in order to reduce risk and costs while allowing for an efficient and robust supply-chain.• Responsible for the procurement of clinical shippers and supplies for distribution• Process necessary Oracle transactions related to Order Management (from shipment/receipt to close-out of order) according to standard operating procedures, GDP, and cGMP’s• Cycle Count / Inventory Reconciliation • Remain in compliance with all applicable regulatory and internal policies related to domestic and international transportation• Safely operate all motorized equipment including forklift truck, electric pallet jacks, lifts, and company vehicles. • Utilize data acquisition system (DAS) for alarm monitoring and record notes in PAMS• Generate reports from Business Objects; prepare labels using Bartender• DOT, IATA, and Hazardous Material certified

Saugus Ma

• Residential electrical work (Wiring Kitchen appliances, lights, outlets, and switches)• Ran wire for service upgrades• Located root causes of potential electrical issues and resolved the problem

Arlington Ma.

• Operated and monitored the ice cream manufacturing process from beginning to end to ensure tight production deadlines and FDA regulations were met.• Maintained accurate batch records of manufacturing activities, including ingredient input and operational changes• Operated Homogenizer and Press to bring product to appropriate temperature in conformance with FDA regulations• Monitored pasteurization equipment during batch process and took corrective action for task failures• Performed equipment preventive maintenance including changing seals and minor repairs• Cleaned piping equipment using CIP system and manual cleaning as necessary• Received raw materials for processing and selected samples for quality control testing• Transferred pasteurized product for further processing based on production requirements• Monitored packaging line to ensure conformance with quality control standards• Worked in conjunction with other production personnel to resolve problems