• Conduct Laboratory Quality Management Program (QMP) monthly metrics and Quality Management Review. Collaborate with management team to organize, monitor, and analyze monthly key performance metrics. • Executed internal audits based on CAP/CLIA and NY regulations. Assisted external audits. • Lead nonconformances (NCs) and CAPA activities; work with Lab Management to verify root causes and implement corrective actions. Verified effectiveness through regular monitoring. • Spearheaded… Show more • Conduct Laboratory Quality Management Program (QMP) monthly metrics and Quality Management Review. Collaborate with management team to organize, monitor, and analyze monthly key performance metrics. • Executed internal audits based on CAP/CLIA and NY regulations. Assisted external audits. • Lead nonconformances (NCs) and CAPA activities; work with Lab Management to verify root causes and implement corrective actions. Verified effectiveness through regular monitoring. • Spearheaded the training and competency program to meet business goals. Collaborated with departments (e.g. Lab Ops, HR, Compliance) to develop and assign trainings through eDMS.• Enhanced documentation standards by writing new SOPs and revising existing documents.• Complete quality assurance operational requirements by managing the QMS database, equipment qualifications, the Approved Supplier List (ASL), and DHRs.• Selected, recruited, and trained Document Control Specialist. • Managed Post Market Surveillance activities for timely product monitoring.• Maintain domestic certifications and registrations.• Create and update Standard Operating Procedures (SOPs), optimizing existing procedures and enhancing regulatory compliance.• Manage Post-Market Surveillance activities, proactively addressing potential product issues and safeguarding patient safety. Show less

• Processes and controls storage of Quality Records which includes change requests, procedures, specifications, protocols, reports, drawings, electronic and hardcopy archives, and notebooks.• Interacts directly with users of controlled documentation to ensure internal conformance to Company Quality Control requirements.• Routes and releases controlled documents.• Reviews format and conformance necessities to documents; including but not limited to signature, dating and Good… Show more • Processes and controls storage of Quality Records which includes change requests, procedures, specifications, protocols, reports, drawings, electronic and hardcopy archives, and notebooks.• Interacts directly with users of controlled documentation to ensure internal conformance to Company Quality Control requirements.• Routes and releases controlled documents.• Reviews format and conformance necessities to documents; including but not limited to signature, dating and Good Documentation Practice• Assists in Food and Drug Administration (FDA) inspections and Notified Body audits regarding marketed products, as requested.• Tracks, and facilitates timely documentation review, approval, and implementation.• Distributes documents in accordance to control procedures to ensure only most recent versions are available for use and that they are available as needed.• Communicates with internal customers to ensure necessary changes are concise and complete.• Provides support to internal customers with documentation needs.• Updates electronic document profiles with personnel changes, e.g., Doc Owner, approved changes, etc. Show less

• Coordinate, support, and collaborate with Project Managers, Directors, CRAs, and Pathologists regarding project status and issues. • Lead, trouble-shoot, and accomplish tasks provided by Project Managers in order to complete project goals. • Worked directly Quality Assurance to ensure company’s documents accommodate to quality control requirements and Good… Show more • Coordinate, support, and collaborate with Project Managers, Directors, CRAs, and Pathologists regarding project status and issues. • Lead, trouble-shoot, and accomplish tasks provided by Project Managers in order to complete project goals. • Worked directly Quality Assurance to ensure company’s documents accommodate to quality control requirements and Good Documentation Practices (GDP).• Accession patient specimens, inventory and archive client’s samples in accordance to SSP, and amend reports. • Process and control storage of Quality Records for over 200 protocols. • Perform aspects of a clinical trial project in compliance with CAP and CLIA guidelines.• Use internal platforms, and excel/excel safe to track tasks' progress, and data entry. Show less