Michael M.

• Developed a Quality Management System (QMS) under the ISO9001-2018 standard. · Designed and implemented a standardized and robust Quality Documentation System that ensured traceability throughout the departments. · Streamline testing processes by introducing automated tools, increasing efficiency and reducing errors. · Evaluated all documentation and SOPs for update, correction, optimization, and standardization. · Conducted regular audits to ensure adherence to established protocols, maintaining consistency and integrity across the organization. · Collaborated with cross-functional teams to identify root causes of product issues, leading to timely resolutions and continuous improvements. · Trained team members on quality assurance principles, fostering a culture of accountability and high performance serving as an internal advisor in the current company’s rules, policies, SOPs, and regulations compliance. Monitoring all company's activities to identify areas of opportunity through the quality process improvement approach. · Occupational Health & Safety leader in charge of reviewing and updating the company’s OHS SOPs, training all personnel about health and Safety best practices, and identifying areas of improvement. · Designed and implemented a robust OHS program to train and educate all personnel in best health and safety practices.

• · Developed a Quality System to qualify the best products through supplier quality audits and determine the best quality testing to offer customers. · Performed water analysis for proper filtration media and technology selection according to the company’s quality requirements. · Conducted water sampling for bacteria analysis and water quality level determination · Completed technical report on laboratory data interpretation · Maintained customer service relationships; including follow-up to ensure quality through all business activities. · Managed the business accounting activities to ensure compliance · Distributed the company budget amount operation, marketing, payroll, accounts payable, purchasing, etc. · Managed and supervised all sales and marketing activities · Trained and supervised company technicians. · Water purification system sales consultant achieving a consistent monthly increment of 10% through 25% of sales activities annually. · Production and field supervisor.

• High Purity Water equipment upgrade validation process certification. · IOQ and PQ protocol development and review for the qualification process. · Regulatory risk assessment, nonconformance investigation development, and report writing. · Improved regulatory compliance levels by conducting thorough risk assessments and developing effective control measures. · Ensured up-to-date knowledge of regulatory requirements through continuous research and monitoring of industry trends and changes in legislation. · Cleaning validation project schedule development. · Performed technical and risk assessments and cleaning validation process. · Configuration and validation of cleaning in place (CIP), equipment. · Cleaning validation method development for the new manufacturing equipment and transfer lines. · Validation Master Plan development to establish, standardize, and execute the cleaning validation. · Standard operating procedures (SOPs) development for the intended cleaning validation process. · Correction through the corrective actions and preventive action (CAPA) system.

• Under a Consent Decree, Quality Assessment supports the Evaluation Notifications of Events (NOE) Level III investigations. · Coordination, Tracking, and assignment of NOEs in conjunction with the Third-Party Contractor (Quantic Group), to the responsible personnel for final evaluation/approvals. · Evaluated Notifications of Events (NOEs) using the Excellent Through Quality (EtQ) system of the Quality Assurance system process deviations. · Assisted the Standard Operating Procedures process for updates and revisions as well as the approval of the procedure after being revised. · Completed and wrote investigations as well as CAPA evaluation/generation related to Quality Management System deviations (Nonconformance Levels 1, 2, and 3). · CAPA reviewer for the Investigation, action items, and change control for the investigation closure. · Quality Metrics and reports for the head of the QA department of Notifications of Events (NOEs) for the Site to be presented presentation in a monthly basis to the Site Leadership Team. · Project remediation, providing a technical assessment on quality and regulatory compliance of validation data, manufacturing investigation, NCs, and CAPAs. · Regulatory and Compliance support to correct NCs, manufacturing investigation, and CAPAs to prepare the company for the corporate Quality Audit Process. · SOP development, evaluation, and update to ensure compliance. · Performed Quality investigations to evaluate the issue(s), and determine the root cause(s) to improve processes through the implementation of corrective and preventive actions.

• · ISO 9001-2008 Quality Management System development and Implementation for the entire company · Performed and developed the Laboratory analysis procedures for the finished cosmetic products. · New product formulation support development and improvement to the formulation team. · Supported the production department as quality manager for the blending process, product rework, and product transfer and packing activities. · Provided training on GMP regulation, quality assurance, quality control, and product quality requirements. · Evaluated the laboratory analysis of the bulk, raw material, and finished products quality requirements. · Continual improvement techniques implementation to increase production and quality efficiency. · Production water test report evaluation to ensure the water quality and product quality were maintained. · Budgeting, planning, and purchasing the packaging materials and raw materials associated with the laboratory and manufacturing operations.

• Proven expertise in validation processes, protocol development, and Method Transfer. • Evaluate and Generate DCR (Document Change Request) & DCO (Document Change Order) • Proven expertise in chemical, analytical, and physical analysis of In-Process Materials, Raw Materials, Purity, and Potency of API. • Proven expertise in auditing and approving laboratory chemical processes and sensitive data to assure compliance with GMP, GLP, and company SOPs. • Evaluation and improvement in laboratory procedures. • Extensive experience in many assays techniques and equipment but not limited to GC, KF, IR, UV-VIS systems, GC-HS, Coulometer, TOC, conductivity, cleaning validation samples, and water tests,

Performing routine testing for the manufacturing raw materials as well as purified water. Performing laboratory testing for the cleaning validation swab and rinse samples. Laboratory analysis and validation data reviewing. Sample management and sample receiving using “Admin LIMS” software. Trackwise user, as a laboratory investigation originator. Review raw data as a second peer verifications. Open the laboratory incident and alert the laboratory managements and all departments involved. Immediately perform and document the initial steps to establish root cause. Responsible for the laboratory reagent inventory. HPLC Raw material and finish products analysis. Performing ELISA protein analysis for the cleaning validation swab and rinse samples. Water analysis for the identification of protein residues in manufacturing cleaned surfaces.

Perform sterility testing for the validations of product sterilization process. Protocol development for the validation of laboratory equipment such as: Incubators, GC, HPLC UV and FTIR Train personal in the analytical methods of the ethylene oxide sterilization process. Reviews test results against documentation specifications. Performed GC analysis and troubleshooting. Replacement of GC’s valves and detectors for qualification purposes. Performed safety audits. Follow up safety issues. Supported to the Microbiology analysis such as: agar plate, bacterial medium, lab equipment sterility by autoclave. Performed Water sampling and analysis to verified the reverse osmosis system operation. Water sampling and analysis from sterile rooms to verified ozone permit limits.