Leon Nash Email and Phone Number

Evaluate customer complaints and internal complaints when received by Quality Lab. Perform visual and functional evaluations, measurements, and testing as well as coordinating and overseeing testing performed by others and making sure it is executed properly. Evaluate customer complaints using laboratory instruments which include Keyence Microscope,Coordinate Measuring Machine, CT-Scanner, X-Ray and Optical Comparator device.Ensures that project and team members stay on target to meet established goals and timeline, utilizing filtering features in MS Project to aid in this activity.Assists team members and other departments as necessary or where appropriate to meet established goals, timeline, and budget.Coordinates, executes, and summarizes test trials. Develops, executes, and summarizes experimental protocols. Trending and reporting of the data as needed. Assist with developing and implementing improvements to production processes along with performing evaluations of defect samples.

The Integration of New Filler and Cartoner equipment for Toothpaste line at Facility. (Aug-2107)*Assisted with the FAT of the Filler Equipment (RT60 Prosys Filler).o Worked with Prosys staff to learn the RT 60 Filler equipment and all the functionality of the RT 60 Filler required in order to operate equipment in an efficient manner and train operators. *Assisted with the SAT of the Filler Equipment (RT60 Prosys Filler) upon arrival.* Assisted with the Commissioning implementation involving the New Filler and the New Cartoner.*Project was completed within due date as the Suite dedicated for Toothpaste at this site was able to resume production prior to proposed completion date. The Removal of Yeast from Barley Malt Raw Material (March2018-Oct2018)*Worked with Vice President of Quality and Member of Technical Industrial Development*Develop protocol for engineering study for the Heat Treatment process of the Barely Malt Extract used in Malt toothpaste here at this site. *Executed protocol to heat raw material at desired temperature to eliminate the yeast in a Raw Material used in Malt toothpaste at this site. *Successful completion of protocol and implementation of new Heat Treatment process for this Raw Material with the duration of use within all future Malt toothpaste Lots. Implementation of Nitrogen to RT 60 Filler Equipment for Nitrogen Purge -June2018-Dec2018Researched about Nitrogen and the Different type of Grades to use for the value in which it was needed for this site and product line. Initiated and executed Change Control and Capa’s needed to address issues related to packaging lines. *Vision system project- Collaboration with Optel group with the Qualification and Validation of the Vision systems currently operating at this site in efforts to remove 100% 200% inspection. Systems which were unable to be qualified prior to my arrival.

Performed several investigations in regards to customer complaints. Closed investigations in timely matter to avoid extensions. Work on CAPAs in relation to complaints. Helped get backlog of customer complaints up to date.

Supervised, trained and mentored a group of 6-8 Quality Technicians, to help efficiently reduce the amount of rejected material/waste, ensuring documentation is recorded right first time in real time, knowledge related to CRF-21 guidelines, ways to prevent 483 observations from occurring during FDA audit. Created Standard Work sheets as a way of accountability for QA Technicians, along with tracking and trending any Quality related issues, performing investigation if needed. Weekly line assignments created for QA Technicians to be able to address any issues that may have occurred in their assigned area at that time. Required QA Technicians to perform training at 100% upon due date, or new revision of SOP and other related documents. Supported Gemba Walks throughout the Facility, Gemba Walks are walks throughout the facility to involving leadership team to ensure company in with compliance of Sops, FDA regulations and etc. Volunteered to take over Customer Complaint task for a year until the position was filled. Performed investigations by reviewing batch record along with performing retain Inspections related to products being returned by customer through 3rd party. Held daily meetings with QA Technicians to discuss quality issues or any areas of concerned related to safety, production. Served as a member on MRB, as I was responsible for rejecting product for waste when needed to help close out investigations and ship product to customers. Participated in audits whether internal or by 3rd party organization. Worked on Kaizen projects to help minimize the amount of Micro excursions populating throughout Packaging Lines; defect projects, good documentation project, projects involving raw material issues. Familiarity with SAP functions related to Quality Dept., Infinity QS Certification, OSHA 10

Conducted routine and scheduled inspections of plant areas, equipment and personnel to ensure cGMP compliance. If discrepancies in cGMPs, procedures, systems or techniques are observed, work with Operations management to perform root cause analysis, assist in the initiation and investigation of deviations and the development of CAPAs to correct issues. Responsible for pre-release batch record reviews and resolution of any potential product issues prior to batch release to packaging and distribution. In short, ensure all cGMP and company requirements are met prior to formal product release. Actively worked on the floor to provide oversight to QA technicians and Operations personnel to ensure compliance with standard operating procedures. Proactively identified any opportunities for improvement to product, process, and systems relating to production or QA activities. Helped to ensure compliance with DEA requirements for the site were followed. Build and maintain a staff of professional, highly motivated and knowledgeable individuals. Participate in selection of personnel and provide for their effective and thorough training. Establish standards of performance in accordance with company guidelines and evaluate performance against those standards for all staff members, to include preparing and conducting performance evaluations. Accomplishments Revised SOPS to reflect changes needed to address compliance/ quality issues. Instilled CFR-21 training to Quality team to help assist with FDA preparedness. Skills Used Hardworking, dedicated, trust worthy, stay educated , builds rapport, communicates well, furthermore knowing that Quality is number 1 priority helps everything else fall in

 General knowledge and promotion of the products; sold all store products. Worked with vendors concerning price and availability of the products. Kept track of buy-backs, special orders and damaged product. Handled customers’ complaints and resolve problems. Ranked with the “Top Employee of the Month” position 3 times consecutively. Awarded for most credit applications in district on several occasions. Maintained good relationship with the regular and permanent customers.