Kenneth Moore Email & Phone Number

Durham, North Carolina, United States

Review and approve GMP related documents (i.e. manufacturing and quality control records, stability results, environmental monitoring, calibration, and maintenance reports etc.) pertaining to chemical intermediates APIs, drug substances and drug products for accuracy, completeness, and compliance with UT policies, procedures, and cGMPsPerform Quality Assurance (QA) functions to include but not limited to: area clearances, in-process checks, raw material release, logbook reviews, and AQL Inspections to support manufacturing activitiesCreate, revise and approve labels in support of manufacturing operationsReview and collaborate on draft Batch Records, Protocols, Summary Reports, Standard Operating Procedures (SOPs), Raw Material Specifications, etc.Author SOPs related to Quality Operations activities, as assignedPerforms Internal and Contract Manufacturing Organizations (CMO) batch record review and release for clinical and commercial products, including all equipment prep, intermediate products and solution preparation, as applicablePerform review of Solution Preparation Records and Column Packing RecordsParticipate in quality system project initiativesPerform monthly logbook reviewsProcess rejected lots and product identified for destructionOn-site contact for manufacturing and quality control personnel related to batch record documentation, manufacturing labeling, and other quality operations responsibilitiesProvide support for SAP Master Data changesReview external product temperature excursionsProvide documentation and SME support for regulatory inspections. (FDA, MHRA, etc)Support CPV and APR processes by providing requested data as neededParticipate in quality system project initiativesOther duties as assigned

Durham

• Process incoming material receipt transactions, control and issuance of materials, and preparation of outbound, product shipments.• Issue raw materials to manufacturing to support work order requirements. • Track inventoried and non-inventory material stock levels and perform regularly scheduled physical inventory counts. • Coordinate with Quality Assurance Department to ensure that materials are tested and released in a timely manner. • Process outbound product and product sample shipments in support of the distribution schedule, including but not limited to booking carriers, preparing bills of lading, and obtaining receipt confirmations.• Use SAP Warehouse Monitor to move, transfer and account for all materials, raw and finished, in the plant.

Wake Forest, Nc

• Researched, investigated all inventory variances and made the proper adjustments to inventory• Used SAP Warehouse Monitor to ensure that all inventory, picking, and packing transactions were keyed in a timely manner. • Used SAP to schedule and coordinate the transportation of articles, received in and shipped out of the facility.• Conducted continuous inventory counts, investigated inventory discrepancies and created reports on inventory trends. • Provided Feedback to Workflow Supervisor on quality of transaction movements from warehouse• First point of contact on information concerning all SAP Warehouse Management Core Transactions.• Supervised the activities of a 10 person / 3 shift, Workflow team.

Red Hat Linux Packet Tracer VMware MySQLTFTP Server Ghost Cast Server; Working on major deployment/ upgrade of new workstations and laptop computers to all the employees of Durham city and its government.Assisting with the major project of upgrading and networking the City's Data Center.Provide General End user, PC support including the Imaging (Norton Ghost) of multiple computers with a standard City operating system with the use of Ghostwriter program.Utilized "VNC" to remote into another computer and proceed with technical support. Transferred individuals computer profiles from one machine to another by using Universal Naming Conventions. Monitor the connectivity of all departments and make suggestions to improve communications on the City's domainProvide network support, by assisting management in administering and designing the network system, performing equipment installations, providing technical support and overseeing the hardware and software inventory.Participate in the installations of network equipment and providing technical advice with new technology.SKILLS:Computer/Technical/Communication SkillsProficient with Linux/UNIX operating systems, Cisco router/ switch configuring, and C++ programming.Knowledge of Microsoft Windows configuring and management; including Active Directory and Universal Naming Convention (UNC) activities.Knowledge of VMware/ CentOS virtual computer environments.Educated in Cisco routing protocols and networking small to medium networks to the CCNA level.Alumni of Cisco Networking Academy

Responsible for initiating the processing/ start of each customers unique silicon wafers, which holds many microchips (die).Verified, organized and presented individualized customer's manufacturing instructions and documentation, from the Process Engineers and presented them to the Manufacturing Department, for the processing of Silicon Wafers.Responsible for maintaining the plant's inventory of processed and unprocessed silicon wafers.Prepared product for domestic and international shipment, using correct documentation. Utilized multiple inventory programs (SAP, MAS200, & MESA /Camstar), to maintain proper inventory levels and insure movement of the material in the supply chain model.

Prepared CTM (Clinical Trial Material) that was pharmaceutical, for shipment to sponsors and client sites.Duties included picking, packing and shipment of CTM utilizing proper regulatory shipping methods, in a clean room environment.Maintained all relevant paperwork and stock records used throughout the warehousing process including shipping documentation (both international & domestic).Ensured that all computer transactions had been carried out in a timely and accurate manner Per current SOPs and GMPs, ensured that all material was labeled, stored properly and protected from damage and/or deterioration. Responsible for the training new and existing employees on new and/or revised SOPs and GMPs.Received and inspected all incoming material.

Contacted client companies about their account status with the Training Network.Assisted clients with selecting the correct safety training materials for their unique programs, including those which met all OSHA requirements.Responsible for generating new leads or list of possible customers.

Supervised the daily activities of a 6 member inventory control team.The Liaison between inventory control team members, managerial staff, production operators and customers by utilizing daily production meetings, weekly team lead meetings and e-mail.Implemented a Microsoft Access program, which tracked weekly product movements and helped explain any financial and physical variances.Conducted and analyzed all data concerning weekly cycle counts and annual physical inventories.Helped implement a Receiving Audit Program, which tracked and followed the accuracy of merchandise received and stored into the warehouse.

Bachelor Of Science (B.S.), Computer And Information Sciences And Support Services

A.A.S., Associate Of Applied Science, Network Technologies

A.A., Associate, The Arts

English, Elementary Education And Teaching