Operations; Equipment, Facilities, Materials Management Maintains knowledge of 21 CFR 1271 regulations and AATB GuidelinesResolve operational issues as they arise in a resourceful and prompt manner to prevent impact on the operation. Direct necessary systems to ensure facility and equipment compliance is maintained and processing materials and support areas do not hinder processing. Work with cross functional areas to support compliance, technology transfer and routine operations. Establish objectives and strategies for process improvement, spatial, and function expansion of the operation.

Maintain and promptly resolve any issues that arise on both facilities as well as with the clean room facility to prevent and shorten the time of disruptions to production and operations to ensure goals are metDevelop and manage equipment inventory and comply with all maintenances, calibrations, verifications, IQ/OQ/PQ’s and services for equipment in the facility to minimize non-conformances and ensure the Technical Division has all the proper equipment needed for operationsPlan, execute, and manage the construction and reorganization of staff of the facility to meet growth needsManage the construction project of a new facility to include a clean room and its supporting areas for the Technical Operation DivisionManage the allocation of budget, resources, contracts, and performance of contractorsTrack Project Issues, risks and change requests through project life cycle, escalating severity and priority of items that may delay the projectWork diligently and closely with permit expeditors, clean room contractors, architects, and general contractors to ensure all appropriate permits, drawings, submissions, inspections and CO’s are in place in order to transfer the manufacturing facilityMaintain proper organization and communication with vendors, contractors, and property managersLead and execute the transitioning of all equipment maintenances from paper to an electronic format using our current computer data software systemReview, Revise and Consolidate SOP’s, Work Instructions, and Attachments to improve work flow in the departmentReport, document, and perform investigation of non-conformances and deviations

Oversee material management (Raw Materials, Procurement, & Inventory).Optimize inventory utilization by setting up standing orders and establishing minimum thresholds for GMP supplies.Optimize the ERP & CDSS applications for inventory management, environmental monitoring, and purchasing. Train users on using the different systems.Oversee and perform purchasing activities as dictated by the Technical Division.Manage the company’s building and facility operations (construction, renovations, clean rooms, etc.)Equipment coordinator, manage equipment inventory & ensure that preventive maintenances, calibrations, and validations/qualifications are performed according to the manufacturers and regulatory requirements. Manage the facilities contracts and monitor the performance of outside contractorsReport, document, and perform investigation of non-conformances and deviationsManage the central monitoring system of the clean room facilityReport, document, and perform investigation of non-conformances and deviations

Use and improve database/report generation software applications.Develop and improve Quality Assurance and processing proceduresSupervise associates in the Receiving Inspection department.Perform internal quality assurance auditsDirect, monitor and evaluate all quality control inspections.

Software administrator.Implemented and improved the software system of the department, as well as activate user accounts and set users with appropriate rights. Compiled, updated, and maintained all CAPA quality assurance documentation & software.Developed solutions to problems with limited scope throughout organization.Coordinated & presented CAPA monthly meetings to upper management.Participated & supported internal and external audits.Implemented successful and efficient process to improve CAPA completion deadlines.