Resume

• 65642

  Certified Quality Auditor

  ASQ

• 2012

  Interdisciplinary Studies

  An interdisciplinary degree of biotechnology and business management. Currently taking classes part time while working full time.

  Biology

  Business

  University of North Texas

  Organizational Behavior

  Operations and Supply Chain Management

  Molecular Toxicology

  Marketing

  General Toxicology

• 2003

  Bachelor of Science (B.S.)

  Biology

  General

  The University of Texas at Arlington

• 2001

  English

  Associate's degree

  Liberal Arts and Sciences/Liberal Studies

  Tarrant County College

• 1849

  Certified Biomedical Auditor (CBA)

  ASQ - World Headquarters

• Process Improvement

  Microsoft Excel

  Validation

  Quality Management

  LIMS

  Quality Auditing

  ISO 17025

  Quality Assurance

  FDA GMP

  Microsoft Office

  Corrective Actions

  ISO

  CAPA

  Internal Audit

  Quality Control

  Environmental Monitoring

  Microbiology

  Technical Writing

  GMP

  Supplier Quality

  Roberts

  Kelly

  Novartis

  Alcon

  a Novartis company

  Analytical Food Laboratories

  Philips

  Home Based

  Manages the clinical audit function within Q&R Compliance and Audit

  in addition to conducting clinical audits.

  Clinical Audit Program Manager

  Philips

  Completes audits to assess accuracy and quality of scientific data\n submitted to the regulatory agencies in support of new drug\n application

  biological licensing agreement

  animal drug application or\n medical devices application. Conducts investigations to ensure\n conformance to regulations and company standard operating procedures.\n Documents audit observations and makes recommendations for corrective\n action. Creates and maintains clinical quality assurance databases

  \n reports

  and files. Acts as an advisor on clinical quality assurance\n protocol amendments and/or biological licensing agreements. Also\n audits operating systems

  processes and procedures.

  Alcon

  a Novartis company

  Quality Control Analyst II

  As a member of the Environmental Monitoring team in the QC Microbiology department for manufacturing of Fort Worth North

  my duties include but are not limited to:\nResponsible for the review

  approval and release of environmental data associated with Fort Worth North product release. \nWrite Nonconformance investigations\nPerform Clean Room Requalifications \nPerform trend analysis of environmental data as needed\nReview and close alarms in relation to environmental impact. \nMake controlled document changes and LIMS template changes \nGarb Qualified

  and trained in air

  surface and personnel sampling

  Alcon Laboratories

  Inc.

  Philips

  Home Based

  Conducting international audits of clinical trials in accordance to GCP standards and local health authority requirements for Medical Devices.

  Sr. Compliance Auditor

  Maintained accreditation to ISO 17025

  NELAC and USDA. \nMaintained registration status to FDA and DEA. \nLead audits with our ISO accrediting body A2LA

  NELAC

  USDA

  FDA as well as client audits. Reduced audit-related deficiencies by 20 % my first year in the position. \nMaintained CUSUM control charts for all accredited testing. \nPerformed internal audits

  performed CAPA investigations and CAPA write ups.\nCompleted supplier quality agreements and supplier risk assessments. \nDeveloped and implemented training programs for CAPA process

  internal auditing

  data integrity and safety. \nMaintained all controlled documents

  responsible for revisions and archiving process.\nValidated laboratory equipment on a monthly

  quarterly and yearly basis. \nReviewed all CAPA's and had final sign off responsibility. \nProficient with CFR's

  cGMP

  ISO 17025 standard

  NELAC standard and USDA guidelines.

  Analytical Food Laboratories

  Novartis

  Home Based

  Support the goals of the GenMed organization by initiating

  monitoring

  and closing out clinical study sites following GCP and ICH guidelines as well as Novartis SOPs and ensuring that study milestones are met. Central point of communication between Novartis and investigational sites for all GenMed clinical trial related activities. Mentor to CRAs. Trial Lead CRA role for a trial when assigned.

  Clinical Research Associate