Experience

Iovance Biotherapeutics, Inc.

• United States
• Biotechnology Research
• 300 - 400 Employee

• Quality Operations Specialist

  • Oct 2022 - Present

  Helps to ensure compliance to cGMPs and facility procedures. Interface with functional groups, such as Manufacturing, Quality Control, and Document Control, to determine events (errors, deficiencies, discrepancies, deviations and other observations) and report to management. • Review batch records and related production documentation, ensuring resolution of all identified issues prior product disposition. Work with internal functions to address all identified issues in a timely manner. Reports errors, deficiencies, discrepancies and observations to management. • Disposition incoming raw materials • Apply quality compliance theories and principles to independently address a variety of issues of moderate scope. Provide guidance on controlled documents (content, quality, and document lifecycle), identifying gaps, addressing documentation needs, and suggesting process improvements • Maintain and report on Quality Metrics. • Initiate and participate in standard operating procedure (SOP) revisions to improve compliance. Maintain and report on Quality Metrics Show less



WuXi AppTec

• China
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Assurance Specialist I/II

  • Aug 2019 - Oct 2022

  Organize and manage activity for multiple clients and internal projects Review and approve: master batch record templates, controlled forms, standard operating procedures, work instructions, label and product specification sheetsKeep up to date with current good manufacturing and documentation practices, as well as FDA and EU standardsInteract frequently with supporting staff for data collection and to provide quality prospective on routine operationsCompile and review raw data, batch records, testing results, environmental monitoring data, and any further client specific documentation required for product release or Certificate of Analysis (COA) issuancePrepare final CoA based on testing/product specifications for product release Review and approve Non-conformance Events, Deviations and Laboratory Investigation ReportsTrain onboarding employees on document review and use of associated support systems, such as: Laboratory Information Management System (LIMS,) MasterControl, Blue Mountain Regulatory Asset Manager, and SAP Business One Review and approve executed batch records; Provide batch record review training to onboarding staff, as well as qualified manufacturing technical reviewersCollect semi-annual metric data for quality risk management agendaAssist with regulatory inspections and client audits Show less

• Manufacturing Technician

  • Apr 2018 - Aug 2019

  Collect, expand, and harvest various client specific cell lines; Collect and culture amniotic tissue and cells Prepare and organize solutions and materialOperate and maintain equipment such as biosafety cabinets, humidified and non-humified incubators, centrifuges, bioreactors, and controlled rate freezersAdhere to aseptic technique and good manufacturing practices (GMP) as well as safety practices with biohazard and dangerous chemicalsCollect and record processing data according to good documentation practices (GDP)Follow, execute, and make improvements to Standard Operating Procedures (SOPs) as well as prepared Batch RecordsUse of support systems: Laboratory Information Management System (LIMS,) MasterControl, Blue Mountain Regulatory Asset Manager, SAP Business One Show less



CVS Pharmacy

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Pharmacy Technician

  • Feb 2015 - Mar 2019