- Daily monitoring of air quality in clean areas using swabbing procedure and Neogen Accupoint Advanced Reader (ATP Testing), according to the established SOP- Collect and perform quality control analysis of purified water used for daily production- Track and report environmental monitoring data to the Quality Manager weekly, to ensure samples are within limits- Oversee employees proper gowning in the cleanroom- Prepare culture media for Bioburden Testing- Prepare, test and create reports of raw materials, in process and final products manufactured daily- Work collaborative with R&D to perform microbiology tests of blends- Conduct sterilization of lab equipment on autoclave used for routine tests- Organize and perform sterilization of liquid and solid waste for disposal- Participate as an active member in investigation of OOS results, being responsible for testing and creating the report, using designated form- Perform monthly calibration of Soleris Next Generation equipment, using manufacturer designated probes- Review and give inputs of SOP's related to the Microbiology Laboratory- Keep and fill out lab logbook and electronic files- Prepare Certificate of Analysis (CofA) for raw materials expiration dates retest and final products that are sent to the clients

- Support the Physical Chemistry and Microbiology Laboratory on collection, review and logging samples received daily for testing- Performed daily equipment verification, for proper function, such as pHmeter, conductivity meter and automatic titrator- Log in final products received for stability tests and performed weight verification, according to the stability test protocol, used for the weight loss test- Washed and sterilized glassware and other materials used on PC and Microbiology Labs

- Performed visual analysis of final products and compared with the specification sheets provided by the Quality Supervisor- Performed physical tests, such as nonwoven GSM and air of +10 package of finished product daily, using proper instruments- Trained and filled out the training log of 20+ peer quality control inspectors- Conducted investigation and of OOS and filled proper paperwork- Performed weekly verification of scales, according to Metrology guidelines, as established on the SOPs- Worked closed to Production and Logistics Departments to ensure products that fail to meet specifications are put on hold or in quarantine until proper investigation is conducted- Created daily reports of the production and submitted it to the Quality Manager at the end of the shift

- Responsible for daily monitoring of manufactured products to ensure the standards were met - Compared raw materials with the supplier and in house CofA's and evaluated the standards were compatible before releasing it to production - Ensured production processes were being performed according to GMPs - Performed statistical and data analysis monthly and submitted information to the Quality Manager - Oversaw and control raw materials intake by the production department. according to established SOPs - Supervised and trained 30+ laboratory and quality inspector personnel

- Reviewed quality control processes at the start up of the machines in the line production - Trained 50+ personnel from production and quality departments on GMPs and designated SOPS - Coordinated schedule of personnel vacation and payroll - Oversaw consumer's complaints and prepared plan of action and investigation of root causes - Prepared Quality Indicators monthly reports - Conducted Analysis of Corrective and Preventive actions - Performed audits of services and raw materials suppliers for compliance with QMS requirements

- Coordinated the development of primary and secondary packaging, according to the guidelines established by the company - Maintained product platforms up to date, to ensure customer's satisfaction - Coordinated machine qualification and package tests to validate designs with new suppliers and completed the associated documentation - Performed product improvement tests and validation of new specifications - Collaborated with the manufacture of packaging dummies for packaging approval

- Performed the analysis of all raw materials prior to entering the plant and compared to established standards - Participated in the development of new materials and qualification of new suppliers

- Performed inspections on the finished product, according to the SOPs - Inspected in process products in the product lines, and reported OOS