Sakita George

Experience

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  Genentech

  Aug 2005 - Jun 2018

  Performs various DS manufacturing tasks including buffer prep and formulation operations using automated Delta V system. Performs solution preparation, sterile filtration and support master production schedule. Follow(SOP) in a cGMP environment and reviewed logbooks check for accuracy. •Conducted environmental monitoring tests utilizing Met One and MASS 100. •Operated production equipment utilizing vessels and portable tanks to perform CIP/SIP.•Administered, review, and authorize spec scan assay utilizing the spectrophotometry for process samples. •Provided support to Validation and Engineering by testing for operational qualifications and process qualifications to execute protocols studies for equipment utilization testing. •Performed Formulation Ultrafiltration/Diafiltration process operations, dilution and conditioning pool adjust operations, and final bulk fill operations. Show less Lead the execution of downstream operations, prioritize and plan area workload efficiently, communicate updates to supervisor and shift pass down meeting. Summarized events or deviations through electronic DMS submissions for QA batch record review. Adhere to site strategic goals. • Identify and resolve potential cGMP issues and ensure compliance with supervisors.• Provided technical guidance to assist Maintenance, ISG and Engineering for troubleshooting, PCO, process equipment, shutdown and restart activities.• Review and maintain records to comply with regulatory requirements utilizing Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP).• Applied and adopt LEAN continuous improvement approach: o Daily efficiency of 5S tool to sustain clean room environment. o Effective use of kanban cards to maintain efficiency of production supplies ordered. Show less Lead the Dispensary operations, manage the flow and storage of raw materials, inventory and proper staging in a safe and orderly manner ensure kits are completed for US and DS manufacturing production.• Operated glass washers for process equipment/parts and document load uses.• Operated Syncade MES to execute workflows to complete material dispensing operation.• Utilized scales including analytical scales/floor scales in weigh booths for dispensing.• Planned workload to ensure activities are performed effectively to support manufacturing.• Dispensed media and buffer components (solid and liquid components) into multi component kits according to batch record instructions and SOP procedures. Show less

  • Senior Bioprocess Technician

    Aug 2015 - Jun 2018

  • Lead Bioprocess Mfg. Technician

    Feb 2010 - Aug 2015

  • Lead Pharmaceuticals Materials Specialist

    Aug 2005 - Feb 2010
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  Bachem

  May 2019 - Jul 2021

  Facilities Technical Coordinator

  Provide support to the Site and/or Facility Managers / Engineering with operational activities in maintenance and operations, accounting and finance, vendor oversight, equipment and supplies, compliance and proactively develop and maintain client relationships ensuring that expected service levels are achieved.• Create and track purchase orders in SAP and process invoice approvals. • Generation and reporting of Facilites KPi's/Metrics. • Generate, review and reconcile of work order management in a timely manner in order to minimize asset downtime. • Interact constructively with employees, managers and cross functional peers. Show less

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  Thermo Fisher Scientific

  Jul 2021 - now

  Responsible for overseeing utility system installation; execute in start-up, commissioning and qualification for a new building project and interacts with cross-functional departments to provide support and guidance in the processing of quality, GMP compliance of the facility supporting the Operations Team in the management, execution and timely closure of Nonconformance reports (NCMRs), Corrective and Preventive Actions (CAPA), and Deviations (DEVs) Represents Operations to provide support to the Facilities and Engineering Departments. Show less

  • Facilities Compliance and Operations

    May 2022 - now

  • Facilities Specialist

    Jul 2021 - May 2022