Mitchell Dale Email & Phone Number

Wheeling, Illinois, United States

Northfield, Il, Us

Quality Manager for Division 40 (Exam Gloves) and Division 41 (Surgical Gloves)

Rosemont, Illinois, Us

Tokyo, Jp

• Oversaw 24/7 IV bag operation of Welding, Incubation, Pasteurization, Initial Inspection, and Final Visual Inspection processes.• Managed 8 direct reports (supervisors) and a total of 200+ indirect reports (hourly associates). • Managed $10M annual budget (labor, materials, consumables, supplies)• Partnered with training manager to create new defect alignment training for improved consistency between inspectors that increased correct inspector detectability and defect assignment by 35%. This decreased Acceptable Quality Limit Failures from 60% to less than <5% within 2 months (Six Sigma Green Belt Project)• Partnered with quality assurance director to create defect library and limit sample templates to align on acceptance criteria which decreased false defect detection by 33%. This effort created specific product specifications for IV bags and allowed alignment between manufacturing, maintenance and quality groups.• Led Change Control for IV defect synchronization for global regulatory conformance within different pharmacopeia guidelines (China, US, Europe)• Created inspector qualification training sets based on internal probability of detection (POD) study data to align with inspection pharmacopeia guidelines• Created/Implemented 3 improvement projects that led to over $2M in labor/material cost savings• Owned Change Control for removal of redundant inspection step which included performing Failure Mode Effects Analysis (FMEA) to identify risks and demonstrate alternative identification steps that would catch defects if they were produced• Owned Change Control for removal of unnecessary process step which included working with regulatory affairs to identify if specific markets required the process step to be performed• Audit facing representative for inspection department who gave tours, explained processes and answered auditor questions. Fully responsible for all internal and external audit findings for department.

Tokyo, Jp

• Oversaw 12/7 IV bag operation of Welding, Incubation, and Final Visual Inspection processes.• Managed 2 direct reports (supervisors) and a total of 60 indirect reports (hourly associates)• Worked with Project Manager and oversaw final inspection area construction based on industry leading recommendations for ideal inspection conditions. Supported validation and qualification processes for equipment operations once new rooms were constructed.• Developed Tier 1 and Tier 2 boards to track daily and weekly metrics and coached team on how to pareto misses and implement the appropriate action items for immediate resolution and prevention of future misses. • Improved manual process efficiency by 235% in first 3 months and demonstrated sustained stability over subsequent year without increased AQL failures nor defect rate detections• Worked with training department to create 4-hour semi-annual training for specific defects based on customer complaint and AQL finding data. This provided continuous improvement loop to continually understand which defects the inspectors struggled based on data driven results from the quality team and external markets.• Trained Level II Deviation Investigator in Trackwise System. o Assessed Impact of deviation including identifying which batches could be affected.o Performed Root Cause Analysis (RCA) based on various investigative tools (i.e. 5 Why, Fishbone Diagram, FMEA, Personnel Interviews, Data Analysis). o Suggested corrective actions and preventive actions based on findings and monitored effectiveness of implemented actions to issue RCA was correct.• Implemented new Powered Industrial Truck (PIT) training based on Crown training material for OSHA compliance. • Created PIT training profiles in LMS and incorporated new training material into system along with qualified trainer assessments to ensure effectiveness of training before employee operates equipment.

Tokyo, Jp

• Managed production floor of 36 hourly employees across 11 different work centers.• Reduced Machine Changeover average from 11 hours to 7 hours (40%+ reduction) during 6-month tenure utilizing single-minute exchange of die (SMED) tactics. Created changeover standard work and rolled out to other shifts for consistency. • Completed Lean Six Sigma Blue Belt Project for reduction of microbial testing time by 50%• Trained to perform bioburden microbial testing on machine • Assisted with environmental monitoring of aseptic room and aseptic gowning testing for employees• GEMBA walks with operators to collaborate and generate improvement ideas to promote continuous improvement brainstorming across shift.• Implemented autonomous process checks to allow operators to self-check their work and ensure seamless shift transition.

Bloomingdale, Illinois, Us

• Managed production floor of 60 employees across 20 different work centers.• Promoted Continuous improvement card program within team which leveraged their expertise to implement several improvement initiatives that created a safer environment and improved efficiency.• Promoted safety in department to improve Safety Activity Program Participation by 200% within first 6 months.• Designed and implemented continuous improvement ideas which increased Units Produced per Labor Hour (UPLH) by 10% in 2018. • Utilized single-minute-exchange of dice (SMED) principles to create standardized work for changeovers along with identifying process steps that can be performed before machine went down. Decreased average changeover times across 20 work centers by 11%• Restructured departmental organization based on understanding departmental responsibilities which increased uptime for machines.• Rearranged department personnel to create developmental opportunities for aspiring employees desiring career growth.• Reorganized rework process flow to improve product traceability and reduced inventory discrepancies.• Increased First Pass Quality by 15% by incorporating training on documentation, ERP transactions, and quality checks. • Developed defect limit samples for different categories (Critical, Major, Minor) and aligned with quality to ensure consistency between departments regarding what is considered a defect.• Trained of FDA Food Safety Modernization Act (FSMA) and worked with quality to incorporate preventive controls including implementing allergen testing to prevent cross contact• Trained on Hazard Analysis Critical Control Points (HACCP) and worked with maintenance and quality to identify potential hazards and incorporate machine controls and microbial testing to monitor potential growth.

Franklin Lakes, New Jersey, Us

Supervise Production Activities in a Union Environment.Ensured scheduled production assignments are delegated appropriately and jobs are completed within the shift.Implemented safety guidelines to improve and promote internal safety along with maintaining a low OSHA rate.Troubleshot equipment and scheduling issues to make sure product is done within the validated time limit and quality specifications.Administered disciplinary action within union guidelines as needed to ensure safe and productive work environment.Headed new ECRs for new equipment to improve production efficiency

Franklin Lakes, New Jersey, Us

Performed scheduled quality testing of in-process samples.Reviewed production order documentation for cGMP errors and reduced quality GMP metric by over 100%.Developed database for equipment maintenance records to increase traceability of repairs/replacement for active equipment.Updated procedures and manufacturing formulas when needed via engineering change requests to improve readability and reduce redundancies within documents.Maintained up-to-date procedure index binders to allow all operators access to effective procedures for reference.Daily calibration and maintenance of pH meters.Maintained Primary Visual Display (PVD) board to give operators and management awareness of monthly reports including quality, safety, and finance metrics.Monitored product operations to ensure manufacturing formulas are followed, documentation is cGMP compliant, and verified prescribed temperatures at various stages of processes.Spearheaded migration project of planned maintenance work into an organized and thorough database to improve traceability and efficiency of maintenance work orders.Coordinated schedules to ensure all divisions are able to complete their duties within the prescribed deadlines.

Franklin Lakes, New Jersey, Us

Obtained information via manufacturing records and pH recordings of different products for data entry.Entered and organized data into a presentable document for easy viewing and understanding.Extrapolated data to find root causes for prior manufacturing problems.Updated and changed format of different manufacturing formulas to mimic an already successful PP3 manufacturing formula.

Taught and mentored camp counselors on safety and appropriate interaction with kids.Held counselors accountable to contract they signed with Springhill prior to job beginning.Conversed with parents that had questions or issues with the camp to help them feel more secure about the safety and reliability of the activities the kids would undergo on a daily basis.Communicated expectations with church leaders to help them understand what exactly would be needed from them and let them know what activities we would have the children doing to help them be knowledgeable of what was occurring on their property.Shared with parents the expectations and activity calendar to make them feel comfortable and aware of what was going on a day-to-day basis.Led morning meetings and afternoon meetings to let counselors know what activities would be going on that day and communicate any issues that occurred the day before.Set up and regulated high adventure activities to maintain a safe but fun environment for the kids and counselors to enjoy while ensuring all measures are being followed to reduce injury probability.

Bachelor Of Science (B.S.), Biology. Psychology. Exercise Science

Master Of Arts - Ma, Industrial And Organizational Psychology