Quality Assurance Shop Floor Specialist III at Legend Biotech (2025-03 – Present)
- Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process.
- Supervise manufacturing and manufacturing support activities for cGMP compliance through spot checks/internal audits. Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing issues.
- Real time review of all documentation, and reporting, in support of process unit operations, in accordance with Good Documentation Practices (GDP).
- Review, revise, or draft Standard Operating Procedures (SOPs).Support on process aseptic process simulations of the processes to ensure sterility of the product/process is not compromised.
- Support material release in SAP for In-house reagents. Strive to reduce non-conformances in supported areas by proactively driving compliance. Support Investigations team by providing quality and compliance input for continuous improvement and remediations.
- Serve as a backup for approving printed labels and documents prior to use on the manufacturing floor.
- Work in a team based, cross-functional environment to complete tasks required to meet business objectives. Support regulatory inspections and audits as needed.
- Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements.
Quality Assurance Shop Floor Specialist at Bristol Myers Squibb (2023-01 – Present)
- Responsible for quality activities supporting Manufacturing Operations in accordance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.
- Functional responsibilities include ensuring manufacturing compliance with applicable procedures, providing a real-time review of manufacturing records and logbooks, and working with Manufacturing Operations to resolve issues.
- Perform product label reconciliation for manufacturing operations.
- Perform FMP walk-throughs of manufacturing and site areas.
Quality Control Lab Technician III at Abbvie, Lifecell Corporation (2022-03 – 2023-01)
- Responsible for supporting QC Laboratory Team in activities associated with the daily operations of QC Microbiology.
- Follow SOPs to perform Quality Control laboratory testing and inspection.
- Operate standard laboratory equipment and performed routine environmental analysis (Air sampling, surface culture).
- Stay current on Good Laboratory Practices and Good Documentation practice. Documented experiment findings in technical lab reports and data graphs.
- Trained new personnel on proper usage and maintenance of laboratory equipment. Documented test results, compiled data and reported on findings to support the overall quality of our product.
- Regularly cleaned and sterilized equipment to avoid cross-contamination and minimize safety risks.
- Maintain Aseptic Processing and Sterile Gowning Qualification
Quality Control Lab Technician II at Allergan, Lifecell Corporation (2018-09 – 2022-03)
- Follow SOP's to perform Quality Control laboratory testing and inspection.
- Operate standard laboratory equipment and performed routine environmental analysis (Air sampling, surface culture).
- Stay current on Good Laboratory Practices and Good Documentation practice.
- Documented experiment findings in technical lab reports and data graphs. Trained new personnel on proper usage and maintenance of laboratory equipment.
- Documented test results, compiled data and reported on findings to support the overall quality of our product.
- Regularly cleaned and sterilized equipment to avoid cross-contamination and minimize safety risks.
- Maintain Aseptic Processing and Sterile Gowning Qualification.
Production Operator Technician II at Lifecell Corporation (2014-07 – 2018-09)
- Responsible for leading the team in a control and regulated medical device environment.
- Responsible for promoting safety, teamwork and meeting processing goals and demands. Responsible for scheduling processing lots, ensuring that all technicians are following the procedures. Exposed to processing human skin which includes both assessment and processing alloderm finishing good.
- Follow the standard aseptic technique procedure Exposed to clean environment processing procedure.
- Operate heat sealers, laminar flow hoods, die press machines for manufacturing tissue-based products.
- Observe and monitor the quality of raw finished products before, during, and after production.
- Compliance with GMP and ISO requirements.
Sales Associate at Ann Taylor Factory Store (2009-09 – 2014-12)
Assisted customers with clothing selection and payments. Recognized as best sales associate for providing excellent customer service and product knowledge.
Sales Associate at DSW (2007-01 – 2009-07)
Provided excellent customer service to customers in a fast-paced, high-volume store. Processed financial transactions for purchases efficiently and accurately. Assisted colleagues to ensure smooth business operations
