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EMAIL AVAILABLE  PHONE NUMBER AVAILABLE  1803 Creekview Lane, Jamison, PA 18929 Biotechnology Quality Assurance Specialist with experience in ensuring compliance with US & Global regulatory standards and GxP implementation.PROFESSIONAL EXPERIENCEAdaptimmune- Philadelphia, PA. March 2024  Present Senior Specialist, Quality Assurance- Lot Disposition Supported the QA activities critical in obtaining FDA Approval for Tecelra, the first FDA approved cell therapy for solid tumors, by ensuring adherence to regulatory requirements and meeting key milestone dates. Preform comprehensive reviews of executed batch records, QC testing data, and batch file documentation, ensuring timely and accurate disposition of patient lots in compliance with regulatory standards. Collaborate with cross functional groups to develop and implement strategies for improving product quality and ensuring GMP compliance, contributing to the continuous improvement of QA operations. Provide support to Qualified Persons (QPs) to ensure thorough review of EU patient batch records. Perform regular line and room clearance to support manufacturing activities in aseptic suites, ensuring adherence to GMP standards. Manage the printing, issuance, and reconciliation of production, QC, and final product labels, ensuring label accuracy and compliance with regulatory requirements throughout the manufacturing process. Oversee inbound and outgoing patient product shipment by ensuring all controls are in place for patient safety and product efficacyPTC Therapeutics- Hopewell, NJ. October 2020  January 2024 Specialist, Quality Assurance Managed QA documentation lifecycles including the authoring, review, and implementation of specifications and Standard Operating Procedures (SOPs). Served as lead during regulatory audits by coordinating with cross-functional teams to prepare quality documentation. Contributed to a 2-week Pharmacovigilance audit conducted by the Health Products Regulatory Authority (HPRA) at the PTC Dublin, Ireland site. Collaborated closely with cross-functional teams to identify and address quality related issues through risk assessments, root-cause analysis, deviations, CAPAs, and lab investigations. Traveled to CDMO sites for routine quality compliance oversight and identify areas for improvement. Developed and managed the Vendor Change Notifications workflow to include company-wide functional groups and appropriate SMEs, streamlining the implementation of changes to raw materials, consumables, and software. Acted as quality approver of raw material testing methods on equipment and in-house or outsourced methods and validationsEDUCATION & CERTIFICATIONSTemple University, Philadelphia, PA May 2020Bachelor of Science in Public HealthDEKRA: Certified Internal Auditor PathWise: CAPA & Deviation Training Completion KNOWLEDGE & INTERESTSTechnical & Industry: SAP, Veeva Vault QMS, Master Control, Trakcel, Microsoft Office Suite, T-Cell & Gene Therapy, Biopharmaceutical Product Lifecycle, FDA, ICH, GMP Interests: Travel, Culinary Arts, Outdoors