Client 2 (Project Quality Engineer)- Served as Change Control Owner, overseeing the development, administration, and presentation of project change controls to the Project Change Management Committee.- Collaborated with cross-functional teams and Subject Matter Experts (SMEs) to gather detailed project information, create change management plans, and secure necessary approvals.- Directed the execution and closure of change control tasks, ensuring precise implementation and comprehensive documentation of all modifications.- Leveraged quality engineering expertise to uphold high standards in change control processes, maintaining strong compliance with regulatory requirements and quality management systems.- Demonstrated strong organizational and project management skills to manage multiple change initiatives, contributing to streamlined project outcomes.- Utilized exceptional written and verbal communication skills to clearly present change plans, ensuring understanding and alignment across project teams and stakeholders.- Applied a meticulous, detail-oriented approach to documentation and compliance, supporting accurate record-keeping and audit readiness.

Client 1 (Quality Assurance Operations)- Managed change control processes to ensure document accuracy and timely updates for SOPs and master batch records, maintained workflows in Trackwise, and ensured tasks were completed and executed on schedule.- Facilitated process improvements across teams as a SmartSheet SME and supported production group SOP updates for ongoing projects to enforce company and regulatory compliance.- Leveraged SmartSheet capabilities to identify needs, set objectives, and streamline processes across cross-functional teams: Metrology, Validation, Engineering, Process Improvement, Planning & Scheduling.- Streamlined Excel document access and functionality by converting crucial data into validated SmartSheet grids, approved for regulated cGMP use.- Developed comprehensive VeevaVault reports, containing key metrics, document status, and graphical analysis utilizing SmartSheet to automate Task Owner notification on upcoming and overdue Change Control items.- Enhanced data management and reporting accuracy, contributing to more informed decision-making and strategic planning.- Worked closely with BMRAM project team for R3 to R4 upgrade; reviewed and approved assets and work orders in BMRAM.- Performed end-to-end project workflows and compared current processes to identify limitations and mitigate risks.

- Managed 52 condominium units and upkeep of common areas of building and outside property.- Liaised between property owners and resolved disputes.- Worked with and determined yearly budgets and assessed need to increase HOA fees appropriately.- Determined projects and need for improvements around building for upkeep.- Worked closely with contractors for building maintenance and upkeep.- Led monthly, quarterly, and board meetings for building and residential needs.

- Analyzed quality standards for components, materials, or services. Applied measures, sampling methods, testing methodology, and other procedures to ensure that quality standards were met.- Applied quality principles, analyzed quality records, prepared reports, and recommended improvements.- Conducted inspection, verification, and validation of components or materials used in development processes.- Identified and addressed recurring problems with quality of product or reliability of testing procedures.- Documented quality issues and performance measures for management review.- Liaised with external vendors.- Assisted in setting up and launching new complaint management system and creating new SOPs. Trained department before launch to familiarize team with new aspects and use of system.- Led team-based cohorts and trainings during live launch.- Worked with coworkers and management to help streamline and improve system and local procedures.- Led project to improve cycle time for tickets to improve customer turnaround time.- Worked collaboratively with coworkers and management to improve and align internal processes with regulatory affairs and department’s approvers.

- Executed routine and non-routine analysis related to cGMP release and characterization testing using analytical techniques including qPCR, immunoassays (ELISA), chromatography (HPLC-ELSD), spectrophotometry, AUC, and electrophoresis (CE, PAGE, western blotting).- Completed assigned work schedule with attention to detail and accuracy.- Initiated laboratory investigations and authored deviation and OSS events / discrepancies in current quality system.- Led special projects on analytical and instrument problem solving by execution of assay.- Understood basic process improvement methodologies, learning and applying concepts of Lean lab and Six Sigma applicable to QC lab environment.- Facilitated training of other team members in organization.- Ensured calibration of analytical equipment and maintained lab.- Conducted review of logbooks and testing packets.

- Worked in and maintained GMP laboratory environment at OSHA VPP star site. - Tested pharmaceutical products in accordance with SOPs, using HPLC, wet chemistry, UV / VIS, GFAA, TLC, GC, Ion Exchange chromatography, Karl Fischer Moisture, and Automatic Titration.- Trained colleagues on new methodologies, including HPLC and GFAA. - Created and led group for chemical quality laboratory improvements. Worked with analysts, managers, and reviewers to identify and address discrepancies in work process to ensure timely, effective, and high-quality documentation practices.- Authored documents with standard chromatography integration guidelines alongside analysts and reviewers.- Produced testing note document SOPs for clarification of method.- Organized, maintained, and scheduled incoming testing to fulfill upcoming business needs.

- Worked with and assisted product developers on multiple projects, creating new formulas and products for in-house and consumer testing and executing experiments per experimental design.- Recorded and reported activities, observations, and results in laboratory notebook and LIMS.- Recorded and graphed analytical and sensory data on various projects, using Microsoft Word and Excel.- Worked with cross-functional groups to execute experiments and evaluate samples.