Keith Donghia Email & Phone Number

Christiansburg, Virginia, United States

World's First Xenotransplantation Clinical Trial Facility

United States (Former Strides Pharmaceutical Plant)

Maintain material accountability against physical quantities and virtual stock amount in SAP during all processes including manufacturing, packaging, and testing of each material and/or controlled substance batch prior to being released for production use or shipping to a customerInvestigate deviations of company SOPs relating to controlled substances and evaluate appropriate action. Create, initialize and close any CAPA’s as requiredRevise and create company SOPs relating to receiving,… Show more Maintain material accountability against physical quantities and virtual stock amount in SAP during all processes including manufacturing, packaging, and testing of each material and/or controlled substance batch prior to being released for production use or shipping to a customerInvestigate deviations of company SOPs relating to controlled substances and evaluate appropriate action. Create, initialize and close any CAPA’s as requiredRevise and create company SOPs relating to receiving, holding and distributing materials, and controlled substances as requestedResponsible for generating and filing all DEA forms as they apply to the acquisition of controlled substances, quota, and destruction.Controlled Substance regulatory compliance focusing on product development activities, exhibit and submit yearly and increase quota applications, as well as tracking the use of yearly quotaCoordinating the destruction of controlled substancesCoordinate the organization and submission of Month End and Year End Reporting to the DEA for all applicable DEA Registrations and materialsCommunicate with local and federal DEA officials as neededKnowledge of 21 CFR Part 1300-End and 21CRF 210 and 211DEA experience in a pharmaceutical environmentAdditional experience within SAP MM, WM, PM and QM ModulesProficient in MS Office Show less

West Palm Beach, Florida (Acquired By Sofgen Pharma)

Manage and monitor the cycle count program within ERP (SAP) system including recounts, discrepancy and reconciliations, and adjustments per approval from Finance.Lead research and documentation of inventory discrepancies. Participate in both regulatory and internal/external financial audits and commitments. cGMP procedures, retrieve documents from the document management system, complete cGMP documents using good documentation practices. Ensure that the inventory quantities on hand are… Show more Manage and monitor the cycle count program within ERP (SAP) system including recounts, discrepancy and reconciliations, and adjustments per approval from Finance.Lead research and documentation of inventory discrepancies. Participate in both regulatory and internal/external financial audits and commitments. cGMP procedures, retrieve documents from the document management system, complete cGMP documents using good documentation practices. Ensure that the inventory quantities on hand are accurately stated and that any adjustments required are charged or credited on a timely basis. Assist with collecting, auditing, and preparing inventory transaction documents and reports. Collaborate to develop shipment schedule and prepare and transact all product and sample shipments. Audit ongoing transactions and reports entered for accuracy; correct discrepancies as needed and escalate results to the appropriate Finance and Operations team. Lead all the daily ERP (SAP) requests such as material transfers and production requests. Frequent contact with employees at all levels within the company. Assist with supply chain production activities. May represent supply chain department on assigned project sub-teams and or task forces as a key support resource.2 additional years cGMP & DEA Controlled Substance experience in a pharmaceutical environment2 years experience with SAP MM, WM, PM and QM Modules Show less

Stuart, Florida, United States

Collaborate with the owner to determine production supply requirementsPurchase supplies and materials according to specificationsCoordinate and supervise receiving and warehousing holding, and distribution procedures.Oversee distribution of supplies within the organizationControl inventory levels and ensure availability of material during emergencies (JIT).Supervise, evaluate and coach subordinates.Maintain relationships and negotiate with suppliers.Keep detailed… Show more Collaborate with the owner to determine production supply requirementsPurchase supplies and materials according to specificationsCoordinate and supervise receiving and warehousing holding, and distribution procedures.Oversee distribution of supplies within the organizationControl inventory levels and ensure availability of material during emergencies (JIT).Supervise, evaluate and coach subordinates.Maintain relationships and negotiate with suppliers.Keep detailed records on procurement activity, materials quantity, specifications etc.Assist in forecasting to plan future orders.Proven experience as materials managerFluent in Domestic and International Shipping Understanding of forecasting and budgetingWorking knowledge of SAP MM, WM, PM and QM ModulesProficient in MS OfficeExcellent organizational and leadership skills Show less

Boca Raton, Florida

Collaborate with other managers to determine production supply requirementsPurchase supplies and materials according to specificationsCoordinate and supervise receiving and warehousing holding, and distribution procedures.Oversee distribution of supplies within the organizationControl inventory levels and ensure availability of material during emergencies (JIT).Supervise, evaluate and coach subordinates.Maintain relationships and negotiate with suppliers.Keep… Show more Collaborate with other managers to determine production supply requirementsPurchase supplies and materials according to specificationsCoordinate and supervise receiving and warehousing holding, and distribution procedures.Oversee distribution of supplies within the organizationControl inventory levels and ensure availability of material during emergencies (JIT).Supervise, evaluate and coach subordinates.Maintain relationships and negotiate with suppliers.Keep detailed records on procurement activity, materials quantity, specifications etc.Assist in forecasting to plan future orders.Proven experience as materials managerFluent in Domestic and International Shipping Understanding of forecasting and budgetingWorking knowledge of SAP MM, WM, PM and QM ModulesProficient in MS OfficeExcellent organizational and leadership skills Show less

West Palm Beach, Florida (Acquired By Strides Pharma)

Managed Receiving / Production/ & Shipping Warehouses

Palm City, Florida

Direct responsibilities involved daily office operations entailed in safely assembling hip, knee, and spine surgeries from the initial case scheduling, to delivery and preparation of instruments and following through the entire device lifecycle including replenishment or replacement phases.Handled all required duties without oversight by management or administration while able to provide strong communication and accurately execute tasks each and every day  Maintained precise physical… Show more Direct responsibilities involved daily office operations entailed in safely assembling hip, knee, and spine surgeries from the initial case scheduling, to delivery and preparation of instruments and following through the entire device lifecycle including replenishment or replacement phases.Handled all required duties without oversight by management or administration while able to provide strong communication and accurately execute tasks each and every day  Maintained precise physical inventories for medical specialties such as orthopaedic, spine, temperature controlled tissue and joint preservation biocomposites.Regulated PAR levels while also preparing and executing audits of both hospital consigned or owned inventories in addition to conserving customer account relationsManaged courier logistics while coordinating regular and stat priority services to and from all patient care facilities. Show less

Port Saint Lucie, Florida

Inventory control duties from fulfilling sales orders, maintaining adequate PAR inventory levels, annual cycle counts with variance and adjustment reports.