Brian Rosemann Email & Phone Number

Bannockburn, Il

- Analyze business processes and create system documentation including design and development plan, system requirements, and functional specifications. Ensure compliance of system documentation with procedures and regulatory requirements. - Facilitate risk assessment activities as part of the design control process. - Provide guidance in interpretation and correct application of the corporate Design Control Method and Design Control Process. - Review and approve… Show more - Analyze business processes and create system documentation including design and development plan, system requirements, and functional specifications. Ensure compliance of system documentation with procedures and regulatory requirements. - Facilitate risk assessment activities as part of the design control process. - Provide guidance in interpretation and correct application of the corporate Design Control Method and Design Control Process. - Review and approve documentation as part of system verification and validation to ensure it is complete, accurate, and compliant with cGMP requirements. - Manage the change control and medical device complaint processes ensuring compliance to 21 cfr Part 820 Quality System Regulation. Show less

Round Lake, Il

- Supervise 17 employees in facilitating complaint handling processes such as incoming phone call and regulatory reporting (approximately 15,000 complaints a month).- Triage teams’ workflows and create performance metrics to monitor goals and work in process for executive management. - Provide direct supervision of individuals including mentoring, performance management, and staffing decisions.- Collaborate with department Trainer to establish individual training plans… Show more - Supervise 17 employees in facilitating complaint handling processes such as incoming phone call and regulatory reporting (approximately 15,000 complaints a month).- Triage teams’ workflows and create performance metrics to monitor goals and work in process for executive management. - Provide direct supervision of individuals including mentoring, performance management, and staffing decisions.- Collaborate with department Trainer to establish individual training plans for all direct reports.- Manage internal process improvements and projects. Identify continuous improvement opportunities for the department and champion their implementation. Represent Product Surveillance on Product Improvement Teams, as well as CAPA investigations.- Assimilate and analyze information for Management Review. Show less

Round Lake, Il

- Create and analyze Field Corrective Action (FCA) metrics and reports for business review and Quality Leadership Team meetings.- Provide accurate and timely data for Regulatory requests, internal and external audits, and ad-hoc requests.- Team member on global process improvements with multi-functional organizations including regional and divisional representation.- Implement a peer review process to eliminate data errors; this directly impacted the First Pass… Show more - Create and analyze Field Corrective Action (FCA) metrics and reports for business review and Quality Leadership Team meetings.- Provide accurate and timely data for Regulatory requests, internal and external audits, and ad-hoc requests.- Team member on global process improvements with multi-functional organizations including regional and divisional representation.- Implement a peer review process to eliminate data errors; this directly impacted the First Pass Acceptance rate on approval of FCA documents.- Perform training on the Field Corrective Action process.- Manage Renal FCA team on an interim basis.- Subject Matter Expert for BioScience Field Corrective Action and Biological Product Deviation processes on an interim basis.- Perform the FDA 483 certification process for the Corporate FCA organization. Show less

Round Lake, Il

Work in Quality Operation Group within a pharmaceutical production facility that utilizes aseptic manufacturing technology. - Support the move of the GLP manufacturing facility pilot plant facility to GMP phase 1 clinical trial facility including validation activities, SOP updates, and process development. - Responsible for inventory levels, warehousing, and shipment of: raw materials, samples, final product, and processing supplies. - Manage a team of 3 employees in… Show more Work in Quality Operation Group within a pharmaceutical production facility that utilizes aseptic manufacturing technology. - Support the move of the GLP manufacturing facility pilot plant facility to GMP phase 1 clinical trial facility including validation activities, SOP updates, and process development. - Responsible for inventory levels, warehousing, and shipment of: raw materials, samples, final product, and processing supplies. - Manage a team of 3 employees in Injectable Formulation Technologies with the following responsibilities: receipt of, inspection, and dispensing of materials; in-process checks of the manufacturing process; change control; systems release; and environmental monitoring processes. - Work directly with Manufacturing to pro-actively schedule supplies and Quality support for the manufacturing process. - Review non batch specific documentation and data including: temperature charts, differential pressure testing, water and pure steam testing, facility cleaning, equipment logs, HEPA filter certifications, room air change testing, and various preventive maintenance tasks. Show less

Round Lake, Il

Manage a staff of 4 employees in the Calibration Laboratory within a commercial pharmaceutical production facility that utilizes aseptic manufacturing technologies. Operate the calibration program (approximately 4,500 calibrations per year) for the production facility and also support the maintenance and introduction of all critical systems within the facility including the aseptic manufacturing complexes.- Write and execute protocols for the Pasteurizer, Penicillin Facility Processes… Show more Manage a staff of 4 employees in the Calibration Laboratory within a commercial pharmaceutical production facility that utilizes aseptic manufacturing technologies. Operate the calibration program (approximately 4,500 calibrations per year) for the production facility and also support the maintenance and introduction of all critical systems within the facility including the aseptic manufacturing complexes.- Write and execute protocols for the Pasteurizer, Penicillin Facility Processes Compressed Air expansion, biologics facility temperature mapping in warehouse, incubator, and 5°C cooler. - Perform technical review of critical systems protocols for Pure Steam and Distilled Water. - Support the development of requirements and specifications for plant critical systems including environmental air systems (HEPA), pasteurization system, aseptic filling machine, process compressed gases, distilled water, pure steam, hydrogen peroxide, pest control, and temperature controlled environments.- Assist in the development, verification, and validation of plant systems including automated monitoring systems. Show less

Ba, Physics

Education record