Ensure that shipments comply with requirements concerning item/country, pricing, and documentation, declaration and country requirements. Coordinate with Augusta Planning team and Master Scheduler to determine the availability of product. Negotiate & prioritize alternative delivery schedules when required. Partner with customers regarding manufacturing changes in product availability, quantity changes, alternative schedules, transport options, product specifications and provide updates throughout the process. Facilitate annual Customer Supply Agreements with Customers outside the United States to outline shipping requirements. Facilitate resolution of shipment temperature excursion investigations with Augusta Manufacturing Science &Technology Group when required. Assisted with the coordination of Clinical Trial material production and delivery. Primary On-Call and management for Tank Farm bulk material scheduling and supplier relations. Responsible for monitoring P-CAP system for Affiliate product action request & facilitation of request closures. Compiled, analyze, & report monthly Supply Chain Customer Service metrics. Oversight of Supply Chain change controls, deviations, Standard operating procedure updates and Q-Plan items to ensure 0% backlogs monthly . Created Customer Service manual to outline steps required to perform the Intercompany Customer Service Assistant role.

Inspection of Quality Managed receivable materials prior to release to be used in the manufacturing process. Support for QA Documentation and Archive Room Coordinators for processing of Standard Operating Procedure reviews, revisions and customer service needs for documentation retrieval and/or filing. Team member for the integration of the Regulus Documentation System and SAP Netweaver project for the site. Performs testing of incoming goods per the appropriate Standard Operating Procedures and product specification requirements. Responsible for the review, revision, and processing of standard operating procedure changes as required for process changes. Management of team logbook to ensure logbooks were updates, reviews and archived in a timely manner. Responsible for creating and maintaining the retain sample management process.

Monitored manufacturing processes to ensure compliance to Standard Operating Procedures for the Formulation Filling and Packaging areas. Performed sampling, inventory, storage and annual inspection of Active Pharmaceutical Ingredients (APIs) and Finished Product retain samples. Performed routine sampling of Raw Materials for Release and Re-evaluation testing. Assisted QA Group Leader in implementing a system for archiving documentation of all required records, logs, and instructions necessary for compliance with cGMP. Inspection of Quality Managed MRO materials (e.g., sterile gowning supplies). Created Specifications for Ex-US countries for inspection of packaging material. Issued batch records to appropriate manufacturing areas when QA group was unavailable.

Generated, logged and issued batch records to the appropriate manufacturing area for production.Secondary to the Quality Assurance Documentation Group to ensure standard operating procedures were generated, reviewed, approved and filed according to procedures. Coordinates packaging, shipping and retrieval of archived files to off-site warehouse for storage, to include preparation of supporting documentation. Ensure appropriate document code numbers and record retention dates were assigned to documents being archived. Managed Logbook project yearly to ensure all logbooks issued to each department older than one year was properly reviewed, archived and new logbooks issued for the current year. Responsible for ensuring originators/responsible individual for specified departments were notified and provided with a listing of documents due for annual or periodic review.Conducted audits of standard operating procedures in each department to ensure all departments were in compliance with current revisions. Customer Service Support for all documentation needs throughout the facility. Active member of the companies Employee Activity, Diversity, Finance, Muster and Area Safety Team Committees. Provide Corporate Regulatory Affairs with updated documentation to support in the preparation of the annual submissions to the FDA.

Assisted in the development of Installation, Operational, Commissioning Qualification for validation protocols. Ensured proper formatting of all validation protocols and reports prior to documents being routed for review and approval. Maintained electronic database for the tracking and approval of all protocols. Validated Provox automation display changes to ensure only documented changes were made. Created discrepancy reports for the automation reports for the Automation Team.

Organized meetings for the Board of Directors, Banker Meetings, and Annual Workshops. Responsible for company finances and budget for administrative and program funds. Developed Excel spreadsheet to track grant funds and bank loans for the organization. Created new filling system for the Rehabilitation Housing Program for accuracy and accountability of project expenditures and documentation. Accountable to Board of County Commissioners, Florida Housing Finance, DCA and U.S. Department of Commerce – EDA for grant funding requirements. Performed site visits with homeowners and contractors to inspect the progress projects.

Independently handled the relocation and restructuring of new office for the company. Initiated new Accounting system to lower accounting cost by $1,000.00 monthly. Handled the processing of all required documentation for the construction of new and remodeled homes. Responsible for the daily operation of the office to include typing, filing, contract preparation, job costing of contracts, scheduled meetings, and annual review of subcontractor’s insurance and license information.

Prepared documentation for the shipment of hazardous materials to vendors. Processed and filed tax documents pertaining to projects conducted in the states of Alabama and Mississippi. Processed payroll for company employees. Maintained Vehicle Maintenance Reports, Drivers Logbooks, and Expense Reports for all company vehicles. Processed project expense reports and job costing for invoicing.

Maintained inventory of supply room stock inventory. Dramatically enhanced accountability of facility inventory by immediately posting property adjustment actions with 99% accuracy. Issued, retrieved, and maintained accountability of unit arms room weapons. Processed incoming personnel to unit. Submitted requisitions and invoices for supplies, tools and equipment to replenish warehouse stock. Assisted the unit mail rook clerk with pick-up, collecting and issuing of unit mail on a routine basis. Provided back-up support for unit administrative office when needed. Supported the Awards NCO by processing and issuing award certificates to individuals recognized for exceptional performance within the unit.