Experience

Novella Clinical

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Lead Quality Control Auditor

  • Aug 2008 - Present

  In addition to duties in previous position:•Responsible for oversight of a selected group of projects and QC Auditors: Coordinate project deliverables with QC leads and QC manager.Manage the timelines and budgets for each project.Oversee designated QC auditors, specifically,Coordination of team meeting attendance, communication of deliverables and CCB coverage for selected group of projects.Mentor on quality processes and advise on documentation.Assure notebooks for each project are audit ready.Assist in process auditing for specific study projects.

• Quality Control Auditor

  • Feb 2008 - Aug 2008

  Primarily responsible for quality control processes relating to customer deliverables. Provided QC support for the Biostatistics, Clinical Programming, Data Management, Information Technology, SAS programming groupsProvided final QC review of all study documents and other client documents (e.g., database QC, Inform QC, data management specifications, SAS output) before they are delivered.Assisted with the evaluation of quality control processes.Assured process compliance with all regulatory and Novella SOPs.Assisted in the scheduling and coordination of all QC activities across projects.



Amkor Technology, Inc.

• United States
• Semiconductor Manufacturing
• 700 & Above Employee

• Quality Technician III

  • 2005 - 2007

  Supported Quality Operations with Final Inspection Reports and Customer Audits.Performed lead auditing of internal audits for recertification of ISO9001:2000.Reviewed documentation for product processing for completion of customer specification.Generated data analysis and final reports to provide with customers’ product.Reviewed records for completed Nonconforming Material Reports, Customer Notifications and Special Work Requests.



Duke Clinical Research Institute

• United States
• Research Services
• 700 & Above Employee

• Clinical Data Assistant III

  • 2004 - 2006

  Support Clinical Data Integration team by performing quality control and audit functions.Performed routine QC checks of database data and Data Management Validation Binders as specified in clinical trial QC plans.Performed data entry, verifications and resolution of data for a critical trial using Clintrial.Performed database queries (SQL) for audit sampling and generated audit reports.Reported any discrepancies of the following audits trail forms: CRF, DVC, DCF and SAE.



VIAVI Solutions

• United States
• Telecommunications
• 700 & Above Employee

• Quality Assurance Specialist

  • 1999 - 2002

  Support achieving/maintaining the 5th TL9000 Certification for Telecommunication within 18 months of the quality start upAdministered and maintained documents utilizing Powerway document control system.Generated SOPs for document control and internal audit systems.Scheduled, conducted, tracked closure and report results of internal audits actions.Tracked closure of actions from meetings, corrective actions and non-conformances.Conducted quality overviews for new employee orientation: demonstrating the use of the document control system, reviewing quality policy, and introduction of ASQ Quality 101.