Quality Assurance and Document Control Manager with a history of enhancing compliance and reducing non-conformities by 12% at Innovex. Skilled in documentation management, process improvement, and achieving ISO certifications. Expertise in quality control systems, regulatory compliance, and team leadership in high-volume manufacturing. Proven ability to reduce defects, boost customer satisfaction, and improve operational efficiency.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Quality Assurance/Document Control Management
Innovex
Houston, TX
2021.12 - 2023.08
Sustained master registries for all active Work Orders, Purchase Orders, Deviation Reports, Non-conformance Reports, Corrective Action Reports, Root Cause Analyses exceeding business and regulatory compliance requirements.
Actively reviewed MTRs, NDE Reports, Heat Treatment Reports, and Coating Reports providing senior management with updated key findings.
Provided feedback to offshore and onshore executive management on status of project deliverables, potential risks associated with the project.
Review, update, and create processes, procedures, and work instructions for Quality Management System.
Implement updated and newly created processes/procedures, and employee training conducted as needed.
Played an instrumental role in preparing and implementing a Quality Management System resulting in receiving ISO:9001-2015/API certifications for the Inflates facility with no major findings.
Developed, implemented, and continue to provide support to ensure the new process has and is remaining compliant as required by the newly released process of receiving materials.
New process includes an updated Q/C Inspection workflow reducing missed non-conformities by 12%, reviewing all Material/Mill Test Reports and Inspection Logs against corresponding Material Specifications.
Created process utilizing Deviation Reports with suppliers to identify material not within the required range per material specification and/or drawings.
Senior Documentation Management/ Control Specialist
Hunting Energy Services
Spring, TX
2020.09 - 2020.11
Sustained master document registers for all active offshore projects exceeding business and regulatory compliance requirements.
Actively reviewed MTRs, NDE Reports, IGLs, and coating reports, updated senior management with key findings.
Prepared and controlled all offshore project and vendor deliverables and final data books.
Provided feedback to executive team on status of project, budget reports, risks associated with project.
Employed a new process to archive all project deliverables and active records, which removed redundancies by 75%.
Project Management and Coordination/Senior Administrative Specialist
Halliburton Energy Services
Conroe, TX
2018.11 - 2019.04
Performed a wide range of tasks regularly, such as making necessary arrangements for accommodations, transportation, and providing personal assistance in collaboration with other executive assistants; delivered exceptional logistical support to visiting executives.
Created and installed a state-of-the-art document management system for the engineering department that enhanced cross-department collaboration, gained better insight, and reduced paperwork for the Onshore Technology group.
Prepared reports on assigned topics by conducting in-depth research and compiling first-hand information.
Developed and executed an innovative method for processing requisitions that significantly decreased resources spent on project month-end reporting by 33%.
Drilling Services Systems Administrator/Document Management
Weatherford International
Houston, TX
2012.08 - 2018.07
Supplied strategic direction and roadmap for developing and implementing processes for nine product lines that reduced operating costs and streamlined said product lines.
Maintained an active role in testing and deploying new functionality in Creo, Inventor, SolidWorks, and Windchill PDM software.
Assessed needs for skills improvement and organized effective training sessions on Windchill PDM, JD Edwards, SharePoint, and numerous in-house systems for more than 35 employees.
Delivered application support and enabled several processes, such as customer liaison and data management for seamless business operations.
Provided documentation management ensuring the correct and necessary was properly released, latest and greatest revisions were available within Windchill, created/reviewed Quality documentation for the QMS.
Resolved issues proactively and eliminated bottlenecks by 65% by employing and enforcing a new process to communicate throughout the life of a project.
Appointed as a project manager by the executive management to head system migration for 30+ projects and selected and trained a top-performing team on new PLM system; surpassed go-live timeline within three weeks.
Analyzed 13,000 mechanical parts and technical specifications for system migration; attained zero downtime for engineering projects, while ensuring data integrity for all offline work.
Document/Quality Control Supervisor
Arc Designs Inc.
Houston, TX
2011.07 - 2012.04
Assumed a leading role in executing preparations for API 4F audit.
Formulated and instituted a cutting-edge document management process, which captured, stored, and retrieved paper and electronic documents, managed documentation for the quality management system.
Chaired safety meetings on a weekly and monthly basis, led site safety inspections, and designed corrective action plans; generated zero LTIs for four years.
Maintained and supplied all project and vendor deliverables throughout project and created and issued final data books.
Lowered ISO audit findings from 5 to 1 and ultimately reached zero findings by actively analyzing and revamping quality documents, consisting of quality manuals, quality plans, quality procedures, inspection, and test plans.
<ul><li>Production Block Incharge Job Role: Operations, Control and Monitoring</li><li>1. All activities related to production and monitoring the process as per SOPs.</li><li>2. Communicate day to day process deviations and breakdowns of the equipment to concerned persons.</li><li>3. Check and implement the process for cleaning of equipment as per the schedules.</li><li>4. Responsible for housekeeping and implementation of day to day cleaning of process area & clean room.</li><li>5. Preparation, review and approval of monthly Reports and BPRs BCRs, OOS, Deviation, investigations reports, validation protocols reports, validation reports.</li><li>6. Responsible for preparation of daily production planning and ensuring the same.</li><li>7. Production planning, ensuring that the batches are produced as per planning and meeting the dispatch targets.</li><li>8. Ensure proper utilization of equipment and manpower as and when required.</li><li>9. Planning and monitoring during execution of the process validation.</li><li>10. Manpower planning. Monitor the project modification activities.</li><li>11. Responsible to handle production processes.</li><li>12. Implementation of new technology w.r.t. process equipments or facility.</li><li>13. Supporting quality assurance team for DMF submission.</li><li>14. Executing and supervising training, validation, qualification and calibrations protocols.</li><li>15. To perform visual inspection and certification of cleaned equipment after product change over cleaning as per standard operating procedure.</li><li>CGMP:</li><li>1. Following departmental standard operating procedures (SOP) and providing suggestions for SOP simplification and any other improvements.</li><li>2. Making sure all the documents and checklist are verified before and after manufacturing.</li><li>3. Ensuring retention and destruction of records are maintained in a department.</li><li>4. Verifying status labeling of accessories, in-process instruments, containers, area & equipment.</li><li>5. Performing contemporaneous (on time) document entries.</li><li>EHS:</li><li>1. Following Environment, Health and Safety policies and practices.</li><li>2. Making sure personnel health, hygiene and organization practices are followed.</li><li>3. To conduct risk analysis of product, system, equipment, process as per standard procedure.</li><li>Training</li><li>1. Attaining training as per training need and providing training to sub-ordinates through available software of Learning Management System (LMS).</li></ul> at MSN Group<ul><li>Production Block Incharge Job Role: Operations, Control and Monitoring</li><li>1. All activities related to production and monitoring the process as per SOPs.</li><li>2. Communicate day to day process deviations and breakdowns of the equipment to concerned persons.</li><li>3. Check and implement the process for cleaning of equipment as per the schedules.</li><li>4. Responsible for housekeeping and implementation of day to day cleaning of process area & clean room.</li><li>5. Preparation, review and approval of monthly Reports and BPRs BCRs, OOS, Deviation, investigations reports, validation protocols reports, validation reports.</li><li>6. Responsible for preparation of daily production planning and ensuring the same.</li><li>7. Production planning, ensuring that the batches are produced as per planning and meeting the dispatch targets.</li><li>8. Ensure proper utilization of equipment and manpower as and when required.</li><li>9. Planning and monitoring during execution of the process validation.</li><li>10. Manpower planning. Monitor the project modification activities.</li><li>11. Responsible to handle production processes.</li><li>12. Implementation of new technology w.r.t. process equipments or facility.</li><li>13. Supporting quality assurance team for DMF submission.</li><li>14. Executing and supervising training, validation, qualification and calibrations protocols.</li><li>15. To perform visual inspection and certification of cleaned equipment after product change over cleaning as per standard operating procedure.</li><li>CGMP:</li><li>1. Following departmental standard operating procedures (SOP) and providing suggestions for SOP simplification and any other improvements.</li><li>2. Making sure all the documents and checklist are verified before and after manufacturing.</li><li>3. Ensuring retention and destruction of records are maintained in a department.</li><li>4. Verifying status labeling of accessories, in-process instruments, containers, area & equipment.</li><li>5. Performing contemporaneous (on time) document entries.</li><li>EHS:</li><li>1. Following Environment, Health and Safety policies and practices.</li><li>2. Making sure personnel health, hygiene and organization practices are followed.</li><li>3. To conduct risk analysis of product, system, equipment, process as per standard procedure.</li><li>Training</li><li>1. Attaining training as per training need and providing training to sub-ordinates through available software of Learning Management System (LMS).</li></ul> at MSN Group
Project Administrator/Document Controller in Quality Assurance at Stacy And Witbeck IncProject Administrator/Document Controller in Quality Assurance at Stacy And Witbeck Inc
Quality Assurance and Quality Control Coordinator at Elite Pharmaceuticals, Inc.Quality Assurance and Quality Control Coordinator at Elite Pharmaceuticals, Inc.