● Initiated, tracked, and managed Corrective and Preventive Action (CAPA) processes from identification to resolution, ensuring timely and effective issue resolution.

● Collaborated with cross-functional teams to investigate root causes, develop corrective and preventive actions, and implement solutions to prevent recurrence of issues.

● Monitored CAPA progress and ensured that actions were completed within established timelines, maintaining compliance with industry regulations and internal standards.

● Designed, developed, and implemented a custom project management tool in Smartsheets to streamline workflow, improve team collaboration, and enhance project tracking of Drug Substance Manufacturing.

● Created a database and reports within smart sheets for projects below $25000 to consolidate best plant metrics of Cost Savings, Cost Avoidance, and Sustainability.

● Assisted in the development standardized risk management plan templates.

● Assisted in the Manufacturing Epogen Product following GDP and SOP Guidelines.

• Writing and Initiating IR, Deviations, CAPAs, Change Controls, OOS, Job Aide Construction

• Creating Equipment Specific SOPs involving Troubleshooting, Primary Maintenance, Cleaning

• Creation of OJT and Training systems for Manufacturing: CAR-T, Aseptic Technique, Media Fills

• Batch Master Record Creation and Implementation

• Tech Transfer and Onboarding of new manufacturing instrumentation

• Upstream manufacturing of stem cells using Amniotic Membrane from Placenta

• lead trainer for centralized manufacturing staff.

• Aseptic Gowning and Aseptic Technique

• Downstream Activities: Fill Finish into glass vials with visual inspection and labeling.

• Upstream Activities: Seed Train in Cell Factory, Expansion into Flasks, Adherent Cell Culture

• Initiating Deviation, Deviation Investigation, and Deviation Closures

• Intiating, Writing, and Closing of OOS, IR, CAPAs

• Change Controls

• Batch Record Review

• Lead trainer