Baresa Hall

Responsible for describing problems, identifying possible causes, collecting and organizing existing data, comparing causes to facts, identifying probable root causes, and determining the best solutions in order to control the manufacturing process.

· Responsible for managing multiple deviation investigations simultaneously.

· Provides follow up and scheduling to ensure batch release process is not impacted by outstanding deviations.

· Ensures investigations will withstand regulatory scrutiny and are compliant with cGMP regulations.

· Works with process experts and production personnel to fully understand and solve problems,

· provides technical expertise and recommends improvements.

· Writes Impact Assessments and Investigation Reports, works within TrackWise.

· Assigns corrective/preventive actions (CAPAs) as necessary in order to resolve problems.

· Performs continuous review and follow-up on investigations to minimize overall product impact and ensure the timely disposition of product that is directly affected.

· Informs Management on the progress of on-going investigations, provides information to and takes direction from the Deviation Review Board.

· Utilizes Word, Excel, Documentum and other electronic systems to complete tasks.

· Maintains compliance with company policies, training requirements, cGMPs and safety standards.

• Observed safety practices and upheld standards.
• Supervised processes to eliminate weak points or bottlenecks in business operations.
• Scheduled appropriate number of employees to complete production line tasks.
• Monitored tool use and performed repairs.
• Developed systems of organization and efficiency to increase production by [Number]%.
• Developed and enhanced personnel work instructions to clear up confusion and boost performance.
• Calibrated machines to maintain required productivity levels and adherence to quality standards.
• Enhanced data gathering, extraction and analysis for diverse workflows and procedures.
• Assisted engineers in developing, building, and testing prototypes and products.
• Inspected products and machines to maintain quality and efficiency.
• Made sure that products were produced on time and are of good quality.
• Investigated processes to develop maps and determine optimal improvement approaches.
• Built product subassemblies or final assemblies and monitored and adjusted production processes or equipment for quality and productivity.
• Mapped process workflows to enhance understanding of procedures.
• Tested products or subassemblies for functionality or quality and troubleshot problems with equipment, devices, or products.
• Examined incoming materials and compared to documentation for accuracy and quality.
• Managed quality assurance initiatives.
• Selected material quantities or processing methods needed to achieve efficient production.
• Inspected finished products for quality and adherence to customer specifications.
• Reviewed production schedules and streamlined processes.
• Prepared reports and technical documentation of day-to-day production processes.

• Trained new employees and delegated daily tasks and responsibilities.
• Managed inventory and ordered supplies to keep location well stocked with necessary supplies.
• Enforced company policies and regulations with employees.
• Delivered superior training and leadership to teams to boost performance and help team members achieve performance targets.
• Prepared shift summary reports for supervisor and communicated regularly on goals and progress.
• Scheduled staff shifts to secure adequate coverage and productive workflows.
• Developed and implemented new processes and procedures to streamline operations.
• Educated staff on organizational mission and goals to help employees achieve success.
• Maintained overall safe work environment with employee training programs and enforcement of safety procedures.
• Evaluated staff performance and provided coaching to address inefficiencies.
• Collected, arranged, and input information into database system.
• Gathered, organized and input information into digital database.
• Developed effective improvement plans in alignment with goals and specifications.
• Developed and updated tracking spreadsheets for process monitoring and reporting.
• Observed packing operations to verify conformance to specifications.
• Generated reports detailing findings and recommendations.
• Maintained database systems to track and analyze operational data.
• Supported creation of detailed, technical financial models to value potential acquisition targets.
• Resolved customer complaints and issues and offered thoughtful solutions to maintain customer satisfaction.
• Managed shift operations, supplied resources and monitored team performance to keep business profitable and running smoothly.