Tech

EvertonUSA and Manchester United USA Social Media Coordinator

Administration & Clerical

•   Social Media Director for EvertonUSA.
•   Social Media Contributor for OneUnitedUSA (Manchester United USA)
•   Event Coordinator and Liaison for Everton F.C. and EvertonUSA.
•   Tour coordinator for soccer supporter groups to Liverpool and Goodison Park

Event/Charity Liaison for Everton F.C. and Global Football America. Coordinate events/tours for Globall Football America in association with Everton F.C.

Operations Liaison

•   Change Management and Liaison between departments
•   Logistics Laison
•   AX Migration and Implementation throughout two facilities in the United States.
•   AX Production and Project Management Module Super User.
•   AX MRP Master Planning, Scheduling and Materials Management.
•   AX Production Routes and Formulas Creation.

Production Planner

Polypeptide Labs
•   Proposing and implementing corrective and preventive actions related to Manufacturing based on audit observations/ recommendations, regulatory inspections, continuous improvement, or otherwise
requested by customers, QA or Senior Management;
•   Reviewing all batch production records, applicable chromatograms, forms, logs and other records to ensure that they are completed and signed prior to transferring them to QA for review; completing all
applicable forms for product review and release;
•   Reviewing and approving documents for other departments on behalf of Manufacturing department
(SOPs, Forms, Specifications, Protocols, Reports, etc. when required/applicable);
•   Creating, revising, approving or rejecting all Manufacturing Documents (MD), forms, procedures and specifications that are necessary for the production of GMP grade peptides and impacting the identi-
ty, strength, quality and purity of the product, reference standard or raw material/components. Ap-
proving these documents on behalf of Manufacturing department;
•   Participating in investigations, risk assessment and other activities when required by Quality System
procedure or policy (such as customer complaint, returns, OOS, etc.);
•   Initiating and reporting all production deviations, out-of-specifications and other discrepancies to QA
and performing investigations, risk assessment and corrections in complete and timely manner; ensur-
ing that such records are closed prior to lot release;
•   Reporting of manufacturing process/steps, preparation of reagents/buffers, verifications/readings of equipment and recording all other required activities on appropriate MDs, forms and other records in
accurate and timely manner.
•   Conducting Line Clearance and ensuring that Line Clearance is performed by QA when required by applicable document;
•   Training Manufacturing personnel to the appropriate level on Manufacturing Documents, SOPs and other applicable documents prior to performing tasks; ensuring / verifying completion of appropriate
level of training for all activities;
•   Using MDs, forms, logbooks and notebooks, that are approved and controlled by QA, for recording
data;
•   Requesting / ordering appropriate raw materials, containers and other applicable items for produc-
tion; using only raw materials and supplies in the manufacture of GMP grade peptides that have been
released by Quality Control according to the approved raw material specifications, stored according
to specified storage conditions, and are within their expiration/ retest dates;
•   Evaluating, justifying and proposing any changes in manufacturing processes or equipment. Initiating
and completing Change Controls for changes in production, materials, facility and equipment when applicable;

Documentation Specialist

Warehouse and production Supervisor involved in interviewing, training and improving work processes.
Scheduled weekly employees overtime and regular hours.
•   Warehouse/Production process management and Warehouse 5S implementation.
•   Inventory Control.
•   Production of Soccer athletic wear. Heat press names, numbers and logos.
•   Nike Event preparation and work. Inventory and retail help.

Warehouse and Production Supervisor

•   Technical Writing; Create/write Work Instructions/SOP's.
•   Operate Hamilton and Tecan Bead MicroLab

Manufacturing Technician/Technical Writer

Lead and assign daily tasks and operations related to aseptic Bulk manufacturing or Filling and Inspection to meet the production Schedule which involve ultrafiltration skids, process tanks, and
automated CIP/SIP (manual set up) systems all through HMI. Also procurement and weighing of raw
materials to be places into stainless steel vessels.
•   Oversee training and adherence to standard operating procedures (SOPs). Maintain a "Right the First
Time" operation.
•   Serve as primary reviewer for all in-process documentation (batch records) as well as the point of contact for all issue resolution
•   Document and approve product and process discrepancies utilizing the TRACKWISE System
•   Schedule and perform routine and advanced duties that are required to maintain the production
facilities and inventory through MRP systems.
•   Remain fully trained in the execution of all aspects of area of responsibility
•   Manufacturing representative for area in scheduling. Work closely with all support departments and other manufacturing leads on scheduling and issue resolution. Prepare shift hand over sheets as
appropriate.
•   Participate and remain current in all departmental medium qualification requirements
•   Lead resources responsible for the authoring, drafting and revising of departmental procedures and practices through MasterControl and Trackwise agile systems
•   Be an active contributor to the departmental staff meetings by occasionally serving as a facilitator
•   Form and support various cross function teams designed to support continuous improvement
measures
•   Interact with outside vendors including the outside cleaning service
•   Worked with purchasing and planners to insure manufacturing inventory was current and fulfilled.
•   Serve as a point of contact for operational/equipment issues
•   Lead facility inspection preparation and readiness for regulatory and partner audits
•   Ensure all (HAZ waste) EH&S policies, procedures and guidelines are maintained and training is
complete for staff.

LEAD PRODUCTION OPERATOR

Operations; Process Management; Insure REES security is validated and refrigerators/freezers are
within range. Calibrate scales, thermometers and nodes.
•   Insure sterility through autoclave and RNase away steps.
•   Manufacturing of solution with chemical base. Assembly of in-line filter and purification systems and dispensing into various sizes utilizing hoods and glove boxes.
•   Conduct the subdivision/aliquoting of raw material into 1MG - 1KG using various scales/balances and a very detailed SOP. Products range from health hazards of 1-4.
•   QC/QA management for ISO9001 audits. Primary operations contact for private and ISO9001 audits.
•   Document preparation such as writing/creating SOP's, FDA letters for customs and manifests for hazardous materials. Also create MSDS and Certificate of Analysis.
•   Initiate and utilize CAPA's (Corrective action/preventive action) by completing action plans; resolving
problems; identifying trends; determining system improvements; implementing change.
•   Project Management; Recruiting/Hiring, selecting, training, assigning, scheduling, coaching, counseling, and disciplining employees.
•   Deal with all validation and regulatory affairs under the guidance of the CEO.
•   Communicating job expectations; planning, monitoring and reviewing job contributions; planning and enforcing policies and procedures.
•   Purchasing; Responsible for data entry of all purchase orders and receipt of vendor confirmations.
Answer phone calls from vendors and company sales reps. Daily inquiries to vendors via telephone, email, fax, and mail. Schedule delivery appointments and late load inquiries. Manage & maintain
purchasing files. Acquire, maintain, & provide all regulatory info as requested. Gather
product/promotional material for sales meetings. Sourcing and setting up new vendors/items as needed.
•   Meet financial objectives following LEAN standards and by forecasting requirements; Ability to budget, forecast and plan.
•   Increase company profitability and customer satisfaction by purchasing materials in a timely manner
and at the lowest cost.
•   Lead manufacturing and production team purchasing by negotiating with vendors
•   Shipping of Hazardous materials which entail creating Shippers declarations and package by IATA
and HAZMAT standards. Shipments are prepared with a 100% accuracy goal; cosmetically and according to all IATA and CFR regulations. Contact carrier representative to make arrangements and to issue instructions for shipping and delivery of materials which entails creation of FEDEX, UPS or DHL
shipping documents. Pack, seal, label, and affix postage/shipping documents to prepare materials for
shipping. Product(s) shipped/received range from -80 - +20C.
•   Drive local deliveries.
•   Receiving using QuickBooks; examine contents and compare with records, such as manifests, invoices, or orders.
•   Issue lot numbers, create CofA's and labels for new or returning products utilizing Microsoft Access and EXCEL.
•   Overall; demonstrated integrity and ethical standards. Strong leadership, motivation and managerial
skills. Manage time effectively and adapt quickly to changing priorities. Superior organizational skills.
Accuracy and attention to detail. Team player who works productively with wide range of people and is comfortable in fast-paced environment.

Project Management & Shipping/Receiving 

Worked as a lab assistant for Gen-Probe Clinical Laboratory where I was responsible for assisting with the manufacture, filling, and testing of kit components by formulating bulk reagents, filling
container/closures for up to runs of 20,000 vials per day.
•   Operate and maintain equipment such as pH meters, balances and filling equipment.
•   Ensure laboratories are fully stocked and maintained in a neat and clean condition.


09/2000 to 10/2004

MATERIAL HANDLER / MANUFACTURING LAB ASSISTANT

Kourosh Toumadje is an EvertonUSA and Manchester United USA Social Media Coordinator at Global Football America in San Diego, CA.

Kourosh Toumadje

Kourosh Toumadje

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