Ariane Davis, Quality Pmp Email & Phone Number

8 years of Quality and Project Management experience in Biotech, Medical Device and PharmaceuticalsResponsible for 30-70 batches running on time per month with a Global CMOTaken a MSC drug product from Phase 1 to Phase 2. Also implemented plan for commercialization of MSC drug product.Chair Member Tampa Section 1508, American Society for Quality (ASQ) PMI - Project Management Professional, Cert #3713244ISPE and PDA Member Developed a comprehensive tracking system for the manufacturing process that ensured full traceability of each batch. This included establishing or exploiting in-process controls to monitor critical parameters throughout production, coupled with a dashboard designed to develop and track key performance indicators (KPIs). By integrating these systems, we enhanced visibility into the manufacturing workflow, enabling proactive management of quality and compliance throughout the entire process to support regulatory requirements and facilitate timely decision making on product line.With the help of engineers and IT, I configured the system to automatically log all user activities, capturing who made changes, what changes were made, and when they occurred. Additionally, I developed standard operating procedures (SOPs) for the proper use of electronic signatures, ensuring that they were unique to each user and linked to their identity. Training sessions were conducted to familiarize staff with these new processes, emphasizing the importance of data integrity and compliance.Enhanced Batch Record accuracy and functionality resulting in 20% reduction in batch discrepancies and implementing controls based on 50 lot research. Resolved discrepancies in product caused by CMO manufacturing affecting IFU by performing QC checks.Saved $10,000 annually by implementing a QC check of 50 units. This lead to a Change Control with the CMO to enforce pump calibration, which resulted in 70% reduction in returns.

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  University Of South Florida

  Cell/Cellular And Molecular Biology