Hasante Johnson

Trained and mentored new employees to maximize team performance.

Maintained clean and well-organized production areas to avoid Deviations or unnecessary rework delays due to hazards or inefficient layouts.

Verify preparation of Stopper Assemblies, Fill line assemblies and or pump assemblies were consistent with batch records and SOP's. Operate Sterilization equipment autoclave's and deprygeon ovens. Review and revise Batch Records and SOP's to ensure effectiveness. Lead shift Tier meetings to communicate critical information for ongoing processes or delays. 5S areas and participated in Gemba Walks.

• Monitor, clean, prepare and operate sophisticated automated cell processing, cell expansion, and fill and finish equipment for autologous stem cells transplants
• Handle propagation of human cells, including T cells
• Perform Filter testing
• Experienced in Purification, Formulation, Filtration, media preps, cell counting and vortex of cells
• Excellent BSC aseptic /sterile techniques while working in a grade A and B clean room environment
• Follow and adhere to SOPs CGMP regulations with the ability to accurately complete documentation associated with commercial manufacturing
• Ability to think critically with proven troubleshooting and analytical skills
• Experienced in MES/PASX, SAP, Oracle EBS, HMI, MS Word, Excel, track wise, Microsoft outlook and Blue Mountain
• Communicate with different departments for escalations such as MSAT, QA, QC, Facilities and Document Control

• Operates production equipment such as Floor scales, bench top scales, and analytical scales
• Operates off daily production schedule and prioritize to work efficiently
• Perform weight checks and helps maintain accurate inventory levels of raw materials
• Operates Bio safety cabinets and demonstrates aseptic techniques
• Runs washers, autoclaves and assembles solution prep tanks
• Assembles and cleans process equipment
• Monitors processes and performs SIP, CIP, and manual cleaning
• Completes production records and maintains clean room environment to comply with regulatory requirements
• Able to Execute basic troubleshooting
• Knowledge of PASX, SAP, GQC LIMs, HMI, Microsoft office and SharePoint systems
• Able to work in a large-scale manufacturing facility and complete documentation in adherence with GMP and ISO requirements

• Operate Fluid bed for wet and dry granulation
• Verify raw materials for product names and weights prior to processing
• Add API and excipient for wet granulation
• Set-ups adjust and disassemble equipment for production and cleaning
• Visually inspect products for defects and quality prior to discharge
• Document fluid bed readings in accordance with cGmp and Sops
• Operate, clean and set-up Fette 3090, Fette 3100, Kikusui Gemini 855, Sejong P2105
• Check tablets for physical defects such as sticking, chipping, and capping during the entire run of compression
• Responsible for in-process checks average weight, thickness, and hardness
• Preformed Logo checks during compression

• Operate solid dose equipment
• Routinely performed line-specific duties including line inspection and release
• Assisted with the work center changeovers and product movements
• Set up and adjusted equipment including tablet fillers, capers, induction sealers, bottle labelers, check weighers, cartons, and palletizers as needed
• Examined products to detect defects or other visual problems
• Trained and certified in SAP and MES systems

• Operated Fluid bed for wet and dry granulation
• Verify raw materials for product names and weights prior to processing
• Add API and Excipient for wet granulation
• Set-ups adjust and disassemble equipment for production and cleaning
• Visually inspect products for defects and quality prior to discharge
• Document fluid bed readings in accordance with GMP and SOP