Manage the retention, security and preservation of records produced by Blair County, Pennsylvania. -Administrator and configuration manager for OnBase DMS.-Designed and maintain RMS quality system and MS Access database.-Established Record Center facility providing remote on-demand scanning services.-Manage data migrations.-County webmaster.-Responsible for the restoration and preservation of fragile historical records-Supervise 2 - 3 employees.

Responsible for bookkeeping, tax preparation and filing.

Supervised the document and configuration control department for the Patient Care Division. This department managed engineering change requests, controlled documents, and archived corporate records. - Supervised nine employees.- Merged three engineering change control systems into one. This reduced process cycle time, and training costs while virtually eliminating procedural errors. - Revised document control processes to implement SAP R/3. Created a training program and trained approximately 200 employees in the new SAP change control process. - Developed the quality system for the storage, backup and destruction of all corporate records. Created a UI and database in MS Access for record tracking. Established quality system documentation; which, included procedures and the record keeping policy.

Led the product development team in the scale-up and transfer of new diagnostic immunoassays into production.Responsibilities included:- Prepared Gantt chart schedules and human and capital resource allocation plans.- Wrote controlled documentation required for purchasing, manufacturing and inspection.- Coordinated with departments in operations and marketing to ensure a smooth product introduction.- Scheduled pilot production, purchased raw materials, and prepared work orders.- Reviewed and approved batch records, inspection records and IQ/OQ/PQ reports.- Selected suppliers for new raw materials. - Worked with buyers and planners to set up MRP for new products- Provided management with projected standard costs, ROI, budget, and milestone reports.

Lead project engineer for facility, equipment and assay development projects. - Accountable for $1.8 million worth of capital projects. - Prepare project justification for VP of Operations and CEO including ROI, timeline, preliminary designs, etc.- Prepared the controlled documentation, contracts, and validation protocols.- Led projects involving as many as 40 team members including architects, engineers, scientists and contractors. - Worked with the EPA, state and city officials to obtain building permits. - Utilize safety-by-design to ensure employee safety and regulatory compliance. - Coordinated employee training and incorporated trainee feedback into the finalized procedures.- Managed project budgets and schedules and always finished on time and within the budget. Projects included:- Class 10,000 pilot production clean room facility including bulk production. filtration, dispensing, inspection and packaging areas.- Raw material and finished good warehouse facility including pallet racking, and operating procedures.- Walk-in 2 to 8° C work-in-process (WIP) cooler. - Fluid Air fluid bed granulation production and pilot facility.- Hull freeze dryer and a humidity controlled product handling room.- Two class 100 clean rooms.

Completed packaging design projects for diagnostic assays that ran on Hitachi blood analyzers. - Developed a new package design standard to reduce costs, shipping damage, environmental impact and warehouse space utilization.- Redesigned the packaging of the DLS division product line to the new standard.- Tasks included specification writing, package testing, tooling approval, material evaluation, and supplier auditing.- Selected and validated new packaging equipment.- Trained employees in equipment operation.EQUIPMENT: Pressure sensitive labelers, baggers, shrink wrappers, powder, liquid and tablet filler/cappers, label counters and rewinders, barcode printers and verifiers, conveyors, scissor lift tables. Test Equipment for drop, vibration and torque testingPACKAGING COMPONENTS: Printed chipboard and corrugated boxes, blow molded bottles, injection molded caps, printed inserts, pressure sensitive labels and thermoforms.

Developed new packaging and improved existing packaging for the twenty-six diagnostic products used in clinical trials and for sale. Also responsible for packaging of blood analyzer parts, circuit boards and other hardware. - Purchased an in-house desktop publishing computer system which resulted in tighter controls over labeling content, and reduced package development costs. ROI was 4 months. Printed material lead times were reduced from 2 months to 2 weeks. - Wrote purchasing, inspection and packing documentation.- Responsible for design, purchase and support of packaging lines.- Prepared cost analysis of packaging production processes.- Printed material tasks included graphic design, camera ready art approvals, and press checks. - Selected, audited and certified packaging suppliers. - Approved and purchased tooling.- Edited product instruction inserts to ensure accuracy and compliance with regulations.- Authored and designed all product labeling.- Was a member of a four person team responsible for product transfer from research and development to manufacturing. - Trained production personnel in the use of new procedures and packaging equipment.

- Administrated the change control system for documents and bills of materials.- Maintained the master files for these documents. - Wrote manufacturing documents such as SOPs, test specifications, and test methods.