Tonbara Apreala

• Worked on a unique ground-floor, startup opportunity in Infant Nutrition as site sanitation manager.
• Successfully prepared the site for FDA inspection readiness and approval, overseeing the site’s sanitation, waste management, and pest control programs.
• Drive the site’s efforts to proactively develop procedures and processes for prevention of food safety incidents through deployment of best-in-class sanitation standards, reducing and mitigating risk.
• Served subject matter expertise role on sanitation, pest control and waste management questions during FDA and other regulatory inspections as the site prepared for product launch, including leading investigative role in corrective action and preventive action root cause analysis of complex pathogen, foreign material and pest control challenges.
• Defined clear targets, and objectives and communicated to other team members, including meeting cleaning frequencies as established in the Master Sanitation Schedule.
• Established team priorities, maintained schedules and monitored performance.
• Recruited, interviewed and hired employees and implemented mentoring program to promote positive feedback and engagement.
• Organized and oversaw assignments to drive operational excellence.
• Streamlined and monitored quality programs to alleviate overdue compliance activities.
• Controlled resources and assets for department activities to comply with company, industry, and government standards and regulations.
• Evaluated employee performance and conveyed constructive feedback to improve skills.

• Provided direct supervision, coaching, and leadership expertise to a shift of distribution personnel that progressed through various stages of team development in the clinical supply chain distribution operation, involved in picking, packing, and shipping of clinical trial drugs to various clinical test sites around the globe, assuring that all materials delivered by the company comply with cGMP, operating procedures, and other applicable regulations.
• Led chartered teams to reduce picking errors by 55% involving picking of incorrect quantity of primary components, using practical process improvement tools and team leadership skills to drive technician performance improvements, resulting in more than 55% reduction in picking of incorrect primary components.
• Completed certification program as a corporate practical process improvement (PPI) train-the trainer.
• Led chartered site-wide cross-functional teams to train and use the principles of practical process improvement (PPI) business system techniques to increase on-time-delivery (OTD) of frozen shipments by 5%, by improving processing time by 20%.

• Provided guidance and oversaw the Plant Services team operations, involved in the management and development of the Sanitation, Pest Control and Waste management programs for the facility with a continuous improvement focus, while ensuring training and technical support for employees in the department and maximizing efficiencies.
• Achieved superior results, including successful FDA and SQF Level III inspections by managing through a Sanitation Supervisor and department unit leaders, as well as a sanitation team of 36 skilled hourly associates, crewed primarily on second shift, to provide sanitation services within a 611,000-square foot frozen food manufacturing facility

• Managed the Sanitation Department and directed all activities necessary for the cleaning and sanitizing of production and packaging equipment and facilities; included dry storage areas, on a daily basis in multiple facilities and ensured that all duties were performed in accordance with USDA ( United States Department of Agriculture) SSOP (Standard Sanitation Operating Procedures) HACCP (Hazard Analysis Critical Control Points) FDA (Food And Drug Administration) GMP (Good Manufacturing Practices) all safety policies and procedures and other established policies and requirements necessary to produce quality products through effective and cost efficient sanitation program.
• Developed, facilitated, and delivered food safety and sanitation training to all department employees in efforts to achieve team development and regulatory compliance and SQF Level II Certification (FDA, USDA, SQF)

• Managed a shift operation through involved in receiving, warehousing, and shipping of raw materials and intermediate products to vaccine manufacturing operations, assuring that all materials delivered by the team comply with cGMP, operating procedures, and other applicable regulations.
• Actively engaged in activities involving cost containment, efficiency, productivity, operational excellence, and safety
• Coordinated efforts resulting in more than 50% reduction in raw material warehouse staging errors by leading a team in yellow belt day program, involved in identifying and implementing quick process improvement opportunities.
• Facilitated kaizen events involving associates from the shop-floor and leadership, engaged in discussions regarding transfer of job tasks from managers to the shop-floor in support of empowering the shop floor and enabling managers to support a new operating model.

Directed a team of operations personnel in the Glassware and Sterile Supply Department by providing guidance, team development and technical expertise in completing the warehousing, assembly, sterilization, and shipping of bioreactors to various viral vaccine manufacturing operations as well as managing the cleaning and sterilization of returned glassware equipment. Led, Coached and Mentored junior supervisors, quality management, and engineering internship personnel under the general direction of an Associate Director.
• Delivered on department’s goals resulting in more than 90% Right First Time, Schedule Adherence and Internal Customer Service Level Metrics for 2012, decreased overall Deviation Alerts by 35% in 2011 and 2012, and eliminated overdue action items and corrective actions.
• Supported Kaizen events in shop floor with the purpose of determining the various value streams in the department, and using it to identify the need for cycle time reduction, the need to implement a pull process, and the value of process controls and analysis in various work streams in the department.