Deborah Monroe Email & Phone Number

Columbus, Ohio Area

Responsible for batch record auditing, finished product release, quality systems document development and Corrective Action/Preventive Action processes. Managed 12 employees (4 direct/8 indirect reports). • Managed document system for timely issuance of work orders, procedures, and product formulations.• Managed Batch Record system for product release to market.• Managed Corrective Action/Preventive Action program to effectively identify, address, and properly document nonconformities and prevent recurrence.• Managed Complaint Coordinator who conducts Domestic and International consumer complaints.• Provided quality metrics for key performance indicators. • Controlled product release to market via Hold Program • Facilitated WCM Plant Service Level Agreement development and Schedule Adherence Meeting Standards• Key participant in internal and external regulatory audits and inspections.• Planned and administered annual operating budget of more than $1.5MM.

Columbus, Ohio Area

Responsible for two retort sterilization and two aseptic filling lines. Managing 104 employees (14 direct/90 indirect reports). Accountable for key performance indicators, operating goals, and continuous cost, productivity and capital improvements. Leading activities in accordance with safety and GMP standards. Utilizing problem solving techniques, team building strategies to meet or exceed performance standards. • Initiated Supervisor/Exempt OJT certification program.• Developed employee training matrices for each line.• Delivered performance improvements in Employee Health and Safety and Training Metrics.• Developed round-the-clock coverage rotations for exempt and non-exempt employees.• Sponsored BEx Project to reduce batch change over times.• Led selected SMEs in developing plant-wide Root Cause Analysis Training Program.• Successfully completed 2013 Global Leadership Development Program.• Planned and administered three annual operating budgets of $10MM.

Columbus, Ohio Area

Responsible for batch record auditing, finished product release, quality systems document development and Corrective Action/Preventive Action processes. Managed 16 employees (4 direct/12 indirect reports). • Managed document system for timely issuance of work orders, procedures, and product formulations.• Managed Batch Record system for product release to market.• Managed Corrective Action/Preventive Action program to effectively identify, address, and properly document nonconformities and prevent recurrence.• Provided quality metrics for key performance indicators. • Controlled product release to market via Hold Program • Facilitated WCM Plant Service Level Agreement development and Schedule Adherence Meeting Standards• Key participant in internal and external regulatory audits and inspections.• Planned and administered annual operating budget of more than $1.5MM.

San Francisco Bay Area

Responsible for two slab and one extrusion bar manufacturing line. Also, responsible for Plant Sanitation Program. Managed 104 employees (5 direct/115 indirect reports). Accountable for key performance indicators, operating goals, and continuous cost, productivity and capital improvements. Lead activities in accordance with safety and GMP standards. Utilized problem solving techniques, team building strategies to meet or exceed performance standards. • Sponsored GMP/Sanitation Kaizen to improve plant housekeeping and sanitation.• Managed WCM Shop Floor Team.• Supported implementation of Compliancewire Training System.• Drove and assisted with implementation of Zarpac.• Expanded use of internal systems to operations including Maintenance Maximo and Material Inventory Tracking System.• Launched use of Zarpac Equipment Efficiency Tracking System.• Sponsored BEx Project to increase line uptime.• Sponsored BEx Project to reduce dough loss Material Usage Variance.• Implemented 5s Program.• Developed operator OJT certification program.• Planned and administered annual operating budget of $11MM.

Columbus Plant

Responsible for 2007 installation and 2008 start-up of 8 oz. Reclosable Plastic Bottle Line. Manage 55 employees (4 direct/50 indirect reports). Accountable for key performance indicators, operating goals, and continuous cost, productivity and capital improvements. Lead activities in accordance with safety and GMP standards. Utilized problem solving techniques, team building strategies to meet or exceed performance standards. • Managed installation and start-up activities of 65MM sq. ft. 8 oz. Bottle filling and packaging operation, including planning and managing $1.7MM budget for payroll and start-up expenses.• Developed Employee Relation approved hiring practices and guidelines for internal and external recruitment for manufacturing and support operations.• Participant and key approver in equipment selection, factory acceptance testing, validation and commissioning.• Participant and key approver in developing line and support group processes and facility layout.• Launched use of Zarpac Equipment Efficiency Tracking System.• Planned and administered annual operating budget of $10MM.• Sponsored BEx Project to increase line speed from 2009 standard 710 upm to 735 upm.• Sponsored BEx Project to reduce Material Usage Variance.• Lead BEx project to eliminate mid-week Clean-In-Place (CIP) with potential annual savings of $100M.• Implemented 5s Program.• Developed operator OJT certification program.

Columbus, Ohio Area

Responsible for activities to assure compliance with Corporate and Division CAPA-related policies and procedures. This included Non-Conformity Exception Reporting, Investigations, Corrective and Preventive Actions, Consumer Complaints, Management Review, and metrics reporting. Monitored and trended CAPA-related performance data for the purpose of preventive action, metrics reporting and continuous improvement. Coordinated completion of actions with other plant departments and Division Quality Assurance. Monitored progression of CAPA projects and corrective action reports to assure that effective actions were taken and completed in a timely manner.• Facilitated Perfect Batch Team. Improved Perfect Batch rate by 20%. • Completed batch record auditing for finished product batch release.• Performed in-plant training for proper documentation and use of Exception Reports, Investigation Tools, Corrective or Preventive Action Reports.• Implemented Quarterly Product Statistical Review Improvement Process with Analytical Lab Supervisor.• Developed plant procedure for Extraneous Matter Preventative Maintenance (PM) Procedure.• Led cross-functional plant housekeeping accountability team in 5s Strategy to assist departments in developing and improving GMP/Housekeeping Standards. This included developing responsibility zones, housekeeping preventative PMs, red tagging process, performance and results tracking.• Key participant in internal and external regulatory audits and inspections.

Columbus, Ohio Area

Responsible for the supervision of 10 mechanics, 4 electricians, and 4 instrumentation technicians in providing preventative maintenance, calibration and maintenance planned and demand work order completion. As Off Shift Manager responsible for the maintenance of good employee relations and ensuring regulatory compliance while assisting all departments in schedule adherence. This includes safety, quality and good housekeeping and sanitation standards. • Assisted in development of 2006 Budget Plan. • Led department in efficiency improvements to Maintenance Scheduling, this includes upgrading filing system, enhanced PM/Work Order development and approval process, PM Change Request Tracking• Database, and system enhancements. Implemented training to all plant employees on Shawware/Avantis Work Order Mgt. System. Developed key maintenance tracking reports.• Developed shutdown planning program to include early scheduling, communication plan, and performance tracking. • Led maintenance activities for decommissioning of 13 and 8 ounce can lines.• Recommended alternative labor utilization after a reduction in workforce without disruption to the business.• Led Supervisor team in developing GMP/Safety Observations Tracking database. Included writing detailed training manual, and training authorized users. Achieved 75% reduction in average outstanding GMP/Safety Work Orders.• Established/facilitated Maintenance Continuous Improvement Team with production/maintenance participants.• Served on Positive Change Steering Committee. Developed Employee Suggestion Program.

Columbus, Ohio Area

Responsible for supervision of 16 manufacturing operators whose primary assignment is 4 oz. and 8 oz. glass bottle filling. Team also trained to provide flexible coverage on 2 oz. and 13 oz. plastic bottle filling lines. As Off Shift Manager responsible for the maintenance of good employee relations and ensuring all regulatory compliance while assisting departments in schedule adherence. This includes safety, quality and good housekeeping and sanitation standards. • Initiated and co-facilitated Glassline PM Improvement Team with Maintenance Supervisor. Team objective was to develop a method of evaluating equipment PM schedule for increased production uptime.• Re-instituted individual performance discrepancy tracking method. • Transitioned Glassline Team to run production in 13 oz. Can Filling.• Facilitated Safety Initiative Team (2nd Shift Supervisors) in developing a Plant Wide Safety Improvement Project.

Evansville, Indiana Area

Responsible for the supervision of twenty-one manufacturing employees in a 32 Ounce Can Processing and Packaging Operation, CIP/COP Team, eight Shipping and Receiving Attendants and one Receiving Control Clerk.• Completed Process Map of 32 oz. Packaging Operation to target areas for improved efficiencies.• Developed performance metrics, goals, and objectives for improved line efficiencies.• Lead cross-functional Continuous Improvement Team to recommend improvements of the production rework operation. Reduced clerical contacts from three to one by removing non-valued and repetitive functions. • Eliminated batch record delays and improved JIT on rework deliveries by streamlining the filing system from two channels to one.• Reallocated crewing from Glass Line Packaging, Ready-To-Hang Packaging and 32 oz. Packaging to create flexible labor coverage and reduce temporary agency headcount. Resulted in $353,600 annual savings.• Redesigned Discrepancy Reporting System to include Early Alert Notices. Designed training program and delivered training throughout the entire Nutritional Operation. Reduced potential for rework or recall.• Redesigned cleaning program and cleaning documentation systems for the 32 oz. Packaging Line and Dry Receiving Area. Resulted in combined annual overtime savings of $70,000.• Assisted in establishing a “Production Team Leader” position. Developed testing requirements with an area vocational college.• Maintained four labor and two expense accounts of a combined annual budget of $2.5M. Participated as a member of the Expense Team that evaluated total organization P & L Performance.• Initiated the first hourly worker Performance Improvement Program as a positive alternative to termination.

Evansville, Indiana Area

Responsible for supervising forty-nine manufacturing employees in tablet filling, liquid filling, blister filling, tablet printing and equipment washroom in a three-shift operation. Responsible for managing equipment and personnel in packaging projects that meet external and internal specifications; responsible for significant projects such as product launches, line automation, and labor utilization.• Developed and delivered a training program to enhance employee understanding of the organizational “Vision.”• Recommended equipment modifications and equipment upgrades on tablet filling line. Increased average output from 98 bottles per minute to 140 bottles per minute resulting in approximately $600,000 annual increased production.• Recommended equipment modifications and equipment upgrades on blister packaging line. Increase average output from 135 cartons per minute to 160 cartons per minute resulting in approximately $440,000 annual increased production.• As special assignment, supervised shutdown of Mt. Vernon Packaging operations upon corporate decision for plant closing. Completed shutdown two months ahead of schedule.

Evansville, Indiana Area

Supervised thirty manufacturing employees along with an additional employee responsible for Hazardous Waste Disposal, in cleaning details for Pharmaceutical Production at the Evansville and Mt. Vernon, IN facilities. Responsible for significant projects such as delivering team building training for the entire organization and special cost savings alternative team.• Developed housekeeping and sanitation program for Pharmaceutical Manufacturing after outsourcing the Facility Services housekeeping. • Developed task force of hourly production and housekeeping employees to implement cost effective measures while ensuring consistently sanitized and clean production facilities. Team effort resulted in an annual cost savings of $322,000 dollars.• As a special assignment, processed mapped the Distribution Services Department for a re-engineering study.

Evansville, Indiana Area

With team of five supervisors, managed 108 employees in cleaning details for the entire Evansville and Mt. Vernon, IN sites. This included 1.2 million square feet of office, labs, warehousing and manufacturing facilities; responsible for managing personnel activities such as performance, team building and training; scheduling; maintaining cleaning records; investigating and responding to customer complaints; requisitioning equipment and chemical purchases; responsible for significant projects such as safety team and special cost saving alternative team.• Selected as Team Leader of Facility Services Evaluation Team. Recommended contract services which resulted in annual savings of $2.5MM.• Developed the first company safety and environmental team of hourly workers. Approximately $100,000 of initial savings resulted in reduced Lost Time Accidents.• Established corrugate recycling contract resulting in $150,000 annual savings.