Yariet Guzman Diaz

Work on and potentially lead efforts to establish new programs to support Drug Product facility including start-up of formulation, filling, inspection, assembly, and pack and label team.
• Perform assessments of existing procedures/documents to gauge appropriateness for the inclusion of drug product operations; where current documents are not adequate, identify path forward for establishment of procedures.
• Develop, write, review, and approve SOPs, specifications, and other documents to support drug product operations. This includes documents for operation and facility SOPs, quality training, batch documentation, etc.
• Accountable for maintaining project timelines associated with quality assurance initiatives to support the evolving business.
• Oversee the Creation, Control and Maintenance of Visual Inspection Qualification Kits.
• Facilitates VI technician qualification.
• Will be back up for VI AQL Inspectors.
• Perform On-The-Floor quality review of documents, such as: equipment logs, training records, testing results, batch records and supporting documents (electronic and paper based).
• Performs On-the- floor Visual Inspection Observation of Inspectors technique.
• Review and approval of documents including executed Batch Records and SOPs (electronic and paper-based).
• Execute daily operations per management guidance in a dynamic environment.
• Perform daily on-the-floor duties to ensure facilities, equipment, materials and documentation comply with SOPs and safety standards.
• Provide guidance during on-the-floor manufacturing processes (i.e., validation, protocol, and production runs).
• Support audits and inspections (i.e., internal and external).

• Perform quarantine and segregation of drug product and drug product intermediate, as needed.
• Performance of area and line clearances as required.
• Contribute to the continuous improvement culture by identifying areas of opportunity and wastes.

• Provide investigation support as event initiator by clearly and accurately documenting the details of an event, including actions taken to contain the event, in the Deviation Management System (DMS) and Electronic Quality Management System (EQMS), and as event owner by leading the investigation team to ensure completion of the event or investigation in a timely manner.
• Provide support on the implementation and effectiveness monitoring of corrections, corrective actions, and preventive actions (CAPA) from investigations of non-conformances, deviations, and trends, audits, risk mitigations, and process activities, such as validation and engineering modifications within the Electronic Quality Management System (EQMS).
• Review and approve the content of the Master Batch Records (MBR), Generic Master Batch Records (GMBR), Parameter Value List (PVL), Parameterized Batch Records (PMBR), and Equipment Related Specification (ESP) within Manufacturing Execution System (MES) PAS-X by ensuring the accuracy of the Changes and Reasons as part of the Collaborative Design Process and confirmation of all applicable information contained in the MES configuration specifications and validation documents, and active participation in the PrePE to review the functionality of the MBR or ESP in MES Pre-Prod environment.
• Approval of MES relevant recipes in Manufacturing Execution System (MES) PAS-X.
• Approval of new or existing recipes, formulas, operations, routings, and validity rules in Oracle Process Manufacturing (OPM) system.
• Lead and support projects for the creation, configuration, and updates to electronic batch records in Manufacturing Execution System (MES) including Master Batch Records (MBR), Generic Master Batch Records (GMBR), Parameter Value List (PVL), Parameterized Batch Records (PMBR), and Equipment Related Specification (ESP).
• Lead QA Visual Inspection Subject Matter Expert (SME) for the shift by coordinating daily activities to assure process flow, coordinating oversight walkthrough to ensure the completion of preventive maintenance of area and equipments using Blue Mountain Regulatory Asset Manager (BMRAM) system, and coordinate meetings related to and any necessary activities (i.e., manufacturing operations, process sciences, change controls, investigations)
• Provide training to Quality Assurance, Validation, and Manufacturing personnel on proper Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), QSR, Data Integrity (DI), procedures, technical reports, and execution of Electronic Batch Record (EBR) in the Manufacturing Execution System (MES) PAS-X.
• Review and approval of executed internal Drug Product (DP) Manufacturing Records (MRs), Batch Sheets (BS), Electronic Batch Records (EBRs), and their supporting documentation to ensure compliance with applicable written procedures, processing parameters, Standard Operating Procedures (SOP), current Good Manufacturing Practices (cGMP). and any applicable Drug License or Applications.
• Review and approval of Aseptic Process Simulation (APS) records.
• Provide on the floor oversight support during Aseptic Process Simulation (APS) protocols to ensure the receiving, reconciliation, handling, inspecting, enumerating, incubation, and turbidity reads of APS samples.
• Developed customized inspection checklists tailored to unique project requirements, ensuring adherence to specifications and regulations.
• Demonstrated adaptability by rapidly learning new technologies and equipment, maintaining expertise in fast-paced industries.
• Provided expert guidance to junior team members, fostering a culture of continuous learning and improvement within the department.
• Performed root cause analysis on identified defects, leading to targeted improvements in manufacturing processes.
• Minimized production delays by promptly addressing non-conformance issues discovered during inspections.
• Maintained comprehensive records of all inspection findings, highlighting areas for improvement and tracking progress over time.
• Contributed to cost-saving initiatives by identifying opportunities for increased efficiency during routine inspections.
• Collaborated with cross-functional teams to address quality issues and implement solutions for improved product performance.
• Upheld impeccable safety standards throughout the workplace by consistently enforcing policies upon detecting violations during inspections.
• Championed continuous improvement initiatives within the department, ultimately enhancing overall inspection performance and accuracy.
• Improved safety protocols by identifying potential hazards during inspections and recommending corrective actions.
• Ensured compliance with industry standards through meticulous attention to detail during inspections.
• Increased efficiency by streamlining the inspection process and eliminating redundant tasks.
• Reduced equipment downtime by conducting thorough preventative maintenance checks on a regular basis.
• Delivered high-quality reports detailing inspection results, facilitating data-driven decision-making among management teams.
• Optimized workflow by effectively prioritizing and scheduling inspections according to project timelines and resource availability.
• Conducted risk assessments for various projects, identifying potential issues before they escalated into costly problems.
• Played a pivotal role in passing regulatory audits through rigorous preparation efforts and thorough documentation practices.
• Established strong relationships with stakeholders through clear communication of inspection findings and recommendations for improvement.
• Enhanced inspection accuracy by implementing advanced inspection techniques and procedures.
• Reviewed production activities and documentation to check conformance to optimal procedures.
• Rejected unacceptable items and recommended corrective actions.
• Assessed first articles off production runs, completed related documentation and determined level of conformance with specifications.
• Completed receiving, in-process and final inspections on different manufactured components.
• Inspected various units using instruments and proper techniques for reliable results.
• Kept testing instruments and apparatus in good working conditions.
• Checked units for foreign objects, rattles and loose internal hardware with shakedown techniques.
• Tested raw materials, packing components and product samples for regulatory compliance.
• Followed quality assurance policies and procedures to verify work of production team.
• Analyzed repeated malfunctions and deviations to trace root causes and assist with preventive measures.
• Examined products for imperfections and defects.
• Followed standard operating procedures for inspections and tests.
• Recorded inspection and test results on data sheets.
• Monitored product quality at all stages of production process.
• Updated quality control records and reports.
• Trained other workers in inspection and testing procedures.
• Checked color, shape, texture and grade of products and materials against established templates, charts, and samples.
• Followed safety protocols while handling hazardous materials.
• Provided feedback to production team regarding product quality.
• Operated and maintained testing equipment.
• Sampled products to verify compliance with standards
• Provided technical support to production personnel.
• Assisted in developing inspection and testing protocols.
• Repaired faults, reassembled products, and completed additional tests.
• Utilized quality control software to track and analyze product data.
• Investigated customer complaints to take necessary corrective actions.
• Perform analyses according to company procedures which include specifications, test methods, sop's, pharmacopoeia (USP, EP & JP) requirements and current regulatory guidelines in timely manner in order to support the production process, following instructions according to planning.

• Perform quality control checks on products during the production cycle to ensure products meet safety regulations
• Provide Quality oversight to ensure that operations for pharmaceutical products are manufactured according to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and other applicable regulations
• Ensure that the organization of materials, equipment, and facilities comply with cGMP, cGLP practices, and FDA regulations
• In addition, verify that the process and procedures lead to a product that complies with these regulations
• Perform product Acceptance Quality Level (AQL) during the inspection stage and distribute reserve and/or stability samples to the appropriate area performing chain of custody on LIMS
• Drive continuous improvement of the core processes to ensure compliance
• Inspect, verify and document quantifiable characteristics of finished goods, comparing against customer specifications and company quality standards to achieve an acceptable product
• Provide analytical, planning, and coordination support on projects as assigned, reviewing, interpreting, analyzing, and illustrating data to stimulate and support enlightened decision making on deviation or any event that requires it
• Assist the managers and supervisory personnel to solve any production technical problems
• Review and approve the electronic batch record assuring the supporting documentation meets the requirements established in the MPs, Mos and referenced SOP in conjunction with GMP to release and disposition of lot
• Support documentation to confirm completeness, uniformity, accuracy and compliance with GxP
• Ensure deviations are addressed through the established QMS.
• Support and knowledge of SAP, MES, Trackwise, LIMS.
• Approval of Master Batch Records (MBR), Generic Master Batch Records (GMBR), Parameter Value List (PVL), and Parameterized Batch Records (PMBR) within MES.
• Maintained detailed documentation of test results, facilitating knowledge sharing across the organization.
• Enhanced team productivity by streamlining QA processes and adopting best practices.
• Improved product quality by developing and implementing comprehensive test plans.
• Fostered strong relationships with other departments such as development, support, and product management to promote seamless communication throughout the entire product lifecycle.

• Assist process mechanics and maintenance in the operation of injection molding machinery and equipment highly automatized with computer controls such as SCADA, HMI and Fanuc robots.
• Follow and adjust equipment settings and conditions to assure the metrics of quality being aware of expirations dates.
• Recover data yield and 'downtime' of equipment as required for cell leader and/or process improver.
• Maintenance of the 5S.
• Provide training and qualify personnel of the manufacturing area assuring compliance with the requirements of the role.
• Perform status labeling of raw material and products maintaining data integrity and ensure compliance with company SOPs, OSHA, and QSR regulations.
• Assist in validation process and certification of equipment.
• Set up and test industrial equipment to ensure that it functions properly. Operate and repair injection molding industrial equipment.
• Perform QC inspection of the final product.
• Adjust and replace defective or improperly functioning circuitry or electronics components, using hand tools of soldering iron.
• Lead and assist investigations into quality issues such as NCRs.
• Mentored junior team members, contributing to their professional growth and development.
• Established best practices for knowledge sharing, fostering a culture of continuous learning and improvement.

• Developed laboratory testing programs and data analysis while adhering to SOPs, batch records and work instructions.
• Enhanced product quality by developing and optimizing chemical processes and procedures.
• Coordinated and performed analytical tests to comply with established standards and specifications.
• Cleaned and organized laboratory and kept supplies well-stocked to save time, money and promote laboratory efficiency.
• Attention to detail to ensure the performance of analyzes to deliver results to clients on time following company approved SOPs.
• Performed testing methods of analysis such as: Gas Chromatography (GC), High-Performance Liquid Chromatography (HPLC), Biochemical Oxygen Demand (BOD), Sulfate, Inductively Coupled Plasma (ICP) Analysis, Flammability testing, Toxicity Characteristic Leaching Procedure (TCLP) and Waste Extraction Test (WET).
• Perform analyses according to company procedures which include specifications, test methods, sop's, United States Environmental Protection Agency (EPA) requirements and current Good Laboratory Practices (cGLP) guidelines in timely manner in order to support the production process, following instructions according to planning.
• Analyze purchase raw materials against established procedures assuring the compliance with regulations.
• Analyze finished product samples versus specified parameters, using Product Specifications (SPECs) and chemical procedures.
• Fill out monthly, quarterly, and annual reports for chemical laboratory.
• Responsible for the maintenance and update of Material Safety Data Sheet (MSDS), and Standard Operating Procedures (SOPs).
• Coordinate Biochemical Oxygen Demand (BOD) and Total Organic Carbon (TOC) testings for wastewater generated by commercial, industrial and institutional facilities.